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CDISC CT Codelist Short Name,Variable,CDISC CT Codelist Long Name,CDISC CT Codelist C-Code,Seq. for Order,Usages,Domain/Dataset,External Dictionary's Component,Descriptive Information,External Dictionary's Organization,External Dictionary's Name,Allowed Subset of Value(s) from CDISC CT,C-Code for Allowed Subset of Value(s) from CDISC CT,Condition 1,Condition 2,C-Code for Value in Condition 1,Define-XML Data Type,C-Code for Value in Condition 2,Health Authority Provisions
ACN,AEACN,Action Taken with Study Treatment,C66767,1,SDTMIG v3.3,AE,,,,,,,,,,,,
,AEBDSYCD,,,2,SDTMIG v3.3,AE,System Organ Class Code,"Although MedDRA is the terminology used for coding adverse events under the ICH, older data may have been coded using other dictionaries (e.g., COSTART), and data not used to support regulatory approval may be coded with other dictionaries (e.g., SNOMED, ICD-10). \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,AEBODSYS,,,3,SDTMIG v3.3,AE,System Organ Class,"Dictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may not necessarily be the primary SOC. \n Although MedDRA is the terminology used for coding adverse events under the ICH, older data may have been coded using other dictionaries (e.g., COSTART), and data not used to support regulatory approval may be coded with other dictionaries (e.g., SNOMED, ICD-10). \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
NY,AECONTRT,No Yes Response,C66742,4,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
,AEDECOD,,,5,SDTMIG v3.3,AE,Preferred Term,"Although MedDRA is the terminology used for coding adverse events under the ICH, older data may have been coded using other dictionaries (e.g., COSTART), and data not used to support regulatory approval may be coded with other dictionaries (e.g., SNOMED, ICD-10). \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
DIR,AEDIR,Directionality,C99074,6,SDTM v1.7,AE,,,,,,,,,,,,
STENRF,AEENRF,Relation to Reference Period,C66728,7,SDTMIG v3.3,AE,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,AEENRTPT,Relation to Reference Period,C66728,8,SDTMIG v3.3,AE,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
,AEHLGT,,,9,SDTMIG v3.3,AE,High Level Group Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,AEHLGTCD,,,10,SDTMIG v3.3,AE,High Level Group Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,AEHLT,,,11,SDTMIG v3.3,AE,High Level Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,AEHLTCD,,,12,SDTMIG v3.3,AE,High Level Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
LAT,AELAT,Laterality,C99073,13,SDTM v1.7,AE,,,,,,,,,,,,
,AELLT,,,14,SDTMIG v3.3,AE,Lowest Level Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,AELLTCD,,,15,SDTMIG v3.3,AE,Lowest Level Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
LOC,AELOC,Anatomical Location,C74456,16,SDTMIG v3.3,AE,,,,,,,,,,,,
OUT,AEOUT,Outcome of Event,C66768,17,SDTMIG v3.3,AE,,,,,,,,,,,,
PORTOT,AEPORTOT,Portion/Totality,C99075,18,SDTM v1.7,AE,,,,,,,,,,,,
NY,AEPRESP,No Yes Response,C66742,19,SDTMIG v3.3,AE,,,,,Y,C49488,,,,,,
,AEPTCD,,,20,SDTMIG v3.3,AE,Preferred Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
NY,AESCAN,No Yes Response,C66742,21,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
NY,AESCONG,No Yes Response,C66742,22,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
NY,AESDISAB,No Yes Response,C66742,23,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
NY,AESDTH,No Yes Response,C66742,24,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
NY,AESER,No Yes Response,C66742,25,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
AESEV,AESEV,Severity/Intensity Scale for Adverse Events,C66769,26,SDTMIG v3.3,AE,,,,,,,,,,,,
NY,AESHOSP,No Yes Response,C66742,27,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
NY,AESLIFE,No Yes Response,C66742,28,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
NY,AESMIE,No Yes Response,C66742,29,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
,AESOC,,,30,SDTMIG v3.3,AE,System Organ Class,"This should be the term from the primary path for the preferred term. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,AESOCCD,,,31,SDTMIG v3.3,AE,System Organ Class Code,"This should be the code from the primary path for the preferred term. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
NY,AESOD,No Yes Response,C66742,32,SDTMIG v3.3,AE,,,,,N; Y,C49487; C49488,,,,,,
,AETOX,,,33,SDTM v1.7,AE,CTCAE Term,"CTCAE can be used here but is not required by US FDA. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm",US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
,AETOXGR,,,34,SDTMIG v3.3,AE,Grade,"CTCAE can be used here but is not required by US FDA. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm",US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
TOXGRV3,AETOXGR,Common Terminology Criteria for Adverse Events V3.0,C66784,35,SDTMIG v3.3,AE,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA.",,,,,,,,,,
TOXGRV4,AETOXGR,Common Terminology Criteria for Adverse Events V4.0,C87162,36,SDTMIG v3.3,AE,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA.",,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,37,SDTMIG v3.3,AE,,,,,AE,C49562,,,,,,
EPOCH,EPOCH,Epoch,C99079,38,SDTMIG v3.3,AE,,,,,,,,,,,,
DEACNDEV,AEACNDEV,Device Events Action Taken with Device,C111110,39,SDTM v1.7,AE,,,,,,,,,,,,
NY,SUPPAE.QVAL,No Yes Response,C66742,40,SDTMIG v3.3,AE,,,,,,,SUPPAE.QNAM EQ "AETRTEM",SUPPAE.QLABEL EQ "Treatment Emergent Flag",,,,
NY,SUPPAE.QVAL,No Yes Response,C66742,41,TAUG-T1D-PDM v2.0,AE,,,,,N; Y,C49487; C49488,SUPPAE.QNAM EQ "SINTV",SUPPAE.QLABEL EQ "Needs Intervention to Prevent Impairment",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,CE,,,,,CE,C85441,,,,,,
STENRF,CEENRF,Relation to Reference Period,C66728,2,SDTMIG v3.3,CE,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,CEENRTPT,Relation to Reference Period,C66728,3,SDTMIG v3.3,CE,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
NY,CEOCCUR,No Yes Response,C66742,4,SDTMIG v3.3,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CEPRESP,No Yes Response,C66742,5,SDTMIG v3.3,CE,,,,,Y,C49488,,,,,,
ND,CESTAT,Not Done,C66789,6,SDTMIG v3.3,CE,,,,,,,,,,,,
STENRF,CESTRF,Relation to Reference Period,C66728,7,SDTMIG v3.3,CE,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,CESTRTPT,Relation to Reference Period,C66728,8,SDTMIG v3.3,CE,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
,CEBODSYS,,,9,SDTMIG v3.3,CE,,"Dictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may not necessarily be the primary SOC.",,,,,,,,,,
,CEBDSYCD,,,10,SDTM v1.7,CE,System Organ Class Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CEDECOD,,,11,SDTMIG v3.3,CE,Preferred Term,"Many people use MedDRA, but some older data may use other coding dictionaries like COSTART, etc. There is no regulatory Mandate for a specific terminology to be used for CEDECOD. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CEDECOD,,,12,SDTMIG v3.3,CE,ICD-10 Code,"Many people use MedDRA, but some older data may use other coding dictionaries like COSTART, etc. There is no regulatory Mandate for a specific terminology to be used for CEDECOD. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who.int/classifications/icd/en/",World Health Organization (WHO),International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10),,,,,,,,
,CEHLGT,,,13,SDTM v1.7,CE,High Level Group Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CEHLGTCD,,,14,SDTM v1.7,CE,High Level Group Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CEHLT,,,15,SDTM v1.7,CE,High Level Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CEHLTCD,,,16,SDTM v1.7,CE,High Level Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CELLT,,,17,SDTM v1.7,CE,Lowest Level Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CELLTCD,,,18,SDTM v1.7,CE,Lowest Level Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CEPTCD,,,19,SDTM v1.7,CE,Preferred Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CESOC,,,20,SDTM v1.7,CE,System Organ Class,"This should be the term from the primary path for the preferred term. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,CESOCCD,,,21,SDTM v1.7,CE,System Organ Class Code,"This should be the term from the primary path for the preferred term. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
LOC,CELOC,Anatomical Location,C74456,22,SDTM v1.7,CE,,,,,,,,,,,,
LAT,CELAT,Laterality,C99073,23,SDTM v1.7,CE,,,,,,,,,,,,
DIR,CEDIR,Directionality,C99074,24,SDTM v1.7,CE,,,,,,,,,,,,
PORTOT,CEPORTOT,Portion/Totality,C99075,25,SDTM v1.7,CE,,,,,,,,,,,,
NY,CESER,No Yes Response,C66742,26,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
SEVRS,CESEV,Severity Response,C165643,27,SDTM v1.7,CE,,Codelist is not cited in SDTMIG v3.3,,,,,,,,,,
ACN,CEACN,Action Taken with Study Treatment,C66767,28,SDTM v1.7,CE,,,,,,,,,,,,
OUT,CEOUT,Outcome of Event,C66768,29,SDTM v1.7,CE,,,,,,,,,,,,
NY,CECONTRT,No Yes Response,C66742,30,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESCAN,No Yes Response,C66742,31,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESCONG,No Yes Response,C66742,32,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESDISAB,No Yes Response,C66742,33,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESDTH,No Yes Response,C66742,34,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESHOSP,No Yes Response,C66742,35,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESLIFE,No Yes Response,C66742,36,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
NY,CESMIE,No Yes Response,C66742,37,SDTM v1.7,CE,,,,,N; Y,C49487; C49488,,,,,,
,CETOX,,,38,SDTM v1.7,CE,CTCAE Term,"CTCAE can be used here but is not required by US FDA. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm",US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
,CETOXGR,,,39,SDTM v1.7,CE,Grade,"CTCAE can be used here but is not required by US FDA. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm",US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
TOXGRV3,CETOXGR,Common Terminology Criteria for Adverse Events V3.0,C66784,40,SDTM v1.7,CE,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA",,,,,,,,,,
TOXGRV4,CETOXGR,Common Terminology Criteria for Adverse Events V4.0,C87162,41,SDTM v1.7,CE,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA",,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,42,SDTM v1.7,CE,,,,,,,,,,,,
DEACNDEV,CEACNDEV,Device Events Action Taken with Device,C111110,43,SDTM v1.7,CE,,,,,,,,,,,,
NY,SUPPCE.QVAL,No Yes Response,C66742,44,TAUG-Schizophrenia v1.1,CE,,,,,,,SUPPCE.QNAM EQ "CPEIND",SUPPCE.QLABEL EQ "Previous Episode Continuation Indicator",,,,
NY,SUPPCE.QVAL,No Yes Response,C66742,45,TAUG-Schizophrenia v1.1,CE,,,,,,,SUPPCE.QNAM EQ "EP1IND",SUPPCE.QLABEL EQ "First Episode Indicator",,,,
NY,SUPPCE.QVAL,No Yes Response,C66742,46,TAUG-Schizophrenia v1.1,CE,,,,,,,SUPPCE.QNAM EQ "RLSJDG",SUPPCE.QLABEL EQ "Investigator Judgment of Relapse",,,,
NY,SUPPCE.QVAL,No Yes Response,C66742,47,TAUG-Schizophrenia v1.1,CE,,,,,,,SUPPCE.QNAM EQ "VLBIND",SUPPCE.QLABEL EQ "Violent Behavior Indicator",,,,
MODTRN,SUPPCE.QVAL,Mode of Disease Transmission,C127265,48,TAUG-HIV v1.0,CE,,,,,,,SUPPCE.QNAM EQ "MODTR",SUPPCE.QLABEL EQ "Mode of Transmission",,,,
EVAL,SUPPCE.QVAL,Evaluator,C78735,49,TAUG-Influenza v1.1; TAUG-Nutrition v1.0; TAUG-T1D-SSM v1.0,CE,,"EVAL codelist was not associated to EVAL in TAUG-Influenza v1.1. However, logically this codelist would apply.",,,,,SUPPCE.QNAM EQ "EVAL",SUPPCE.QLABEL EQ "Evaluator",,,,
SETTING,SUPPCE.QVAL,Environmental Setting,C127262,50,TAUG-HIV v1.0,CE,,,,,,,SUPPCE.QNAM EQ "SETTNG",SUPPCE.QLABEL EQ "Event Setting",,,,
MODTRN,SUPPCE.QVAL,Mode of Disease Transmission,C127265,51,TAUG-HIV v1.0,CE,,,,,,,SUPPCE.QNAM EQ "MODTR1",SUPPCE.QLABEL EQ "Mode of Transmission 1",,,,
MODTRN,SUPPCE.QVAL,Mode of Disease Transmission,C127265,52,TAUG-HIV v1.0,CE,,,,,,,SUPPCE.QNAM EQ "MODTR2",SUPPCE.QLABEL EQ "Mode of Transmission 2",,,,
NY,SUPPCE.QVAL,No Yes Response,C66742,53,TAUG-TB v2.0,CE,,Uses same codelist as the Findings observation class --ACPTFL variable.,,,N; Y,C49487; C49488,SUPPCE.QNAM EQ "CEACPTFL",SUPPCE.QLABEL EQ "Accepted Record Flag",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DE,,,,,DE,C102616,,,,,,
,DEDECOD,,,2,SDTMIG-MD v1.1,DE,Term,"US FDA CDRH encourages the use of the Medical Device Problem Code Terminology. \n Enter Term to DEDECOD. FDA Code, NCIt Code, and IMDFR Code may optionally go to the SUPPDE dataset. \n Terminology files are available through NCI EVS FTP here: https://evs.nci.nih.gov/ftp1/FDA/CDRH/About.html \n Link to general information about the cited external dictionary, accessed 2022-06-16: https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources-medical-device-reports",U.S. Food and Drug Administration (US FDA),Medical Device Report Annex A: Medical Device Problem,,,,,,,,
DECAT,DECAT,Category of Device Events,C111109,3,SDTMIG-MD v1.1,DE,,,,,,,,,,,,
NY,DEPRESP,No Yes Response,C66742,4,SDTMIG-MD v1.1,DE,,,,,Y,C49488,,,,,,
NY,DEOCCUR,No Yes Response,C66742,5,SDTMIG-MD v1.1,DE,,,,,N; Y,C49487; C49488,,,,,,
ND,DESTAT,Not Done,C66789,6,SDTMIG-MD v1.1,DE,,,,,,,,,,,,
DEACNDEV,DEACNDEV,Device Events Action Taken with Device,C111110,7,SDTMIG-MD v1.1,DE,,,,,,,,,,,,
LOC,DELOC,Anatomical Location,C74456,8,SDTM v1.7,DE,,,,,,,,,,,,
LAT,DELAT,Laterality,C99073,9,SDTM v1.7,DE,,,,,,,,,,,,
DIR,DEDIR,Directionality,C99074,10,SDTM v1.7,DE,,,,,,,,,,,,
,DEREL,,,11,SDTM v1.7,DE,"Section 8, Causality Assessment Terms",,European Commission,"Guidance document - Clinical investigation, clinical evaluation - Clinical investigations: serious adverse event reporting - MEDDEV 2.7/3",,,,,,,,
,DEREL,,,12,SDTM v1.7,DE,,,International Organization for Standardization (ISO),Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155),,,,,,,,
SETTING,SUPPDE.QVAL,Environmental Setting,C127262,13,TAUG-T1D-PDM v2.0,DE,,,,,,,SUPPDE.QNAM EQ "SETTING",SUPPDE.QLABEL EQ "Setting of Device Event",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,DS,,,,,DS,C49576,,,,,,
NCOMPLT,DSDECOD,Completion/Reason for Non-Completion,C66727,2,SDTMIG v3.3,DS,,,,,,,DSCAT EQ "DISPOSITION EVENT",,C74590,,,
PROTMLST,DSDECOD,Protocol Milestone,C114118,3,SDTMIG v3.3,DS,,,,,,,DSCAT EQ "PROTOCOL MILESTONE",,C74588,,,
OTHEVENT,DSDECOD,Other Disposition Event Response,C150811,4,SDTMIG v3.3,DS,,This codelist is not referenced in SDTMIG v3.3 but is part of published CT.,,,,,DSCAT EQ "OTHER EVENT",,C150824,,,
DSCAT,DSCAT,Category for Disposition Event,C74558,5,SDTMIG v3.3,DS,,,,,,,,,,,,
DSSCAT,DSSCAT,Subcategory for Disposition Event,C170443,6,SDTM v1.7,DS,,A codelist for DSSCAT was published with terminology publication 2020-03-27 P41,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,7,SDTMIG v3.3,DS,,,,,,,,,,,,
NY,SUPPDS.QVAL,No Yes Response,C66742,8,TAUG-MDD v1.0; TAUG-Schizophrenia v1.1,DS,,,,,,,SUPPDS.QNAM EQ "RLSIND",SUPPDS.QLABEL EQ "Relapse Indicator",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DT,,,,,DT,C102621,,,,,,
DTDECOD,DTDECOD,Device Tracking and Disposition Event Dictionary Derived Term,C112037,2,SDTMIG-MD v1.1,DT,,,,,,,,,,,,
ACCPARTY,DTPARTY,Accountable Party,C189265,3,SDTMIG-MD v1.1,DT,,,,,,,,,,,,
NY,DTPRESP,No Yes Response,C66742,4,SDTM v1.7,DT,,,,,Y,C49488,,,,,,
NY,DTOCCUR,No Yes Response,C66742,5,SDTM v1.7,DT,,,,,N; Y,C49487; C49488,,,,,,
ND,DTSTAT,Not Done,C66789,6,SDTM v1.7,DT,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,DV,,,,,DV,C147178,,,,,,
EPOCH,EPOCH,Epoch,C99079,2,SDTMIG v3.3,DV,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,HO,,,,,HO,C117757,,,,,,
NY,HOPRESP,No Yes Response,C66742,2,SDTMIG v3.3,HO,,,,,Y,C49488,,,,,,
NY,HOOCCUR,No Yes Response,C66742,3,SDTMIG v3.3,HO,,,,,N; Y,C49487; C49488,,,,,,
ND,HOSTAT,Not Done,C66789,4,SDTMIG v3.3,HO,,,,,,,,,,,,
STENRF,HOSTRTPT,Relation to Reference Period,C66728,5,SDTMIG v3.3,HO,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,HOENRTPT,Relation to Reference Period,C66728,6,SDTMIG v3.3,HO,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
EPOCH,EPOCH,Epoch,C99079,7,SDTM v1.7,HO,,,,,,,,,,,,
STENRF,HOSTRF,Relation to Reference Period,C66728,8,SDTM v1.7,HO,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,HOENRF,Relation to Reference Period,C66728,9,SDTM v1.7,HO,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
HODECOD,HODECOD,Health Care Encounters Dictionary Derived Term,C171444,10,SDTMIG v3.3,HO,,,,,,,,,,,,
SEVRS,HOSEV,Severity Response,C165643,11,SDTM v1.7,HO,,,,,,,,,,,,
DISCHDX,SUPPHO.QVAL,Discharge Disposition,C101863,12,TAUG-COVID-19 v1.0,HO,,,,,,,SUPPHO.QNAM EQ "DCGDSP",SUPPHO.QLABEL EQ "Discharge Disposition",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,MH,,,,,MH,C49603,,,,,,
,MHLLT,,,2,SDTM v1.7,MH,Lowest Level Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHLLTCD,,,3,SDTM v1.7,MH,Lowest Level Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHDECOD,,,4,SDTMIG v3.3,MH,Preferred Term,"Many people use MedDRA, but some older data may use other coding dictionaries like COSTART, etc. There is no regulatory mandate for a specific terminology to be used for MHDECOD. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHDECOD,,,5,SDTMIG v3.3,MH,ICD-10 Code,"Many people use MedDRA, but some older data may use other coding dictionaries like COSTART, etc. There is no regulatory mandate for a specific terminology to be used for MHDECOD. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who.int/classifications/icd/en/",World Health Organization (WHO),International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10),,,,,,,,
,MHPTCD,,,6,SDTM v1.7,MH,Preferred Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHHLT,,,7,SDTM v1.7,MH,High Level Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHHLTCD,,,8,SDTM v1.7,MH,High Level Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHHLGT,,,9,SDTM v1.7,MH,High Level Group Term,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHHLGTCD,,,10,SDTM v1.7,MH,High Level Group Term Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
NY,MHPRESP,No Yes Response,C66742,11,SDTMIG v3.3,MH,,,,,Y,C49488,,,,,,
NY,MHOCCUR,No Yes Response,C66742,12,SDTMIG v3.3,MH,,,,,N; Y,C49487; C49488,,,,,,
ND,MHSTAT,Not Done,C66789,13,SDTMIG v3.3,MH,,,,,,,,,,,,
,MHBODSYS,,,14,SDTMIG v3.3,MH,,"Dictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as \n MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may not necessarily be the primary SOC.",,,,,,,,,,
,MHBDSYCD,,,15,SDTM v1.7,MH,System Organ Class Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHSOC,,,16,SDTM v1.7,MH,System Organ Class,"This should be the term from the primary path for the preferred term. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
,MHSOCCD,,,17,SDTM v1.7,MH,System Organ Class Code,"This should be the code from the primary path for the preferred term. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
STENRF,MHSTRF,Relation to Reference Period,C66728,18,SDTM v1.7,MH,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MHSTRTPT,Relation to Reference Period,C66728,19,SDTM v1.7,MH,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,MHENRF,Relation to Reference Period,C66728,20,SDTMIG v3.3,MH,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MHENRTPT,Relation to Reference Period,C66728,21,SDTMIG v3.3,MH,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
MHEDTTYP,MHEVDTYP,Medical History Event Date Type,C124301,22,SDTMIG v3.3; TAUG-EVD v1.0; TAUG-DKD v1.0; TAUG-MDD v1.0; TAUG-Pain v1.1; TAUG-PTSD v1.0; TAUG-Schizophrenia v1.1; TAUG-LuCa v1.0; TAUG-CHCV v1.0,MH,,,,,,,,,,,,
LOC,MHLOC,Anatomical Location,C74456,23,SDTM v1.7,MH,,,,,,,,,,,,
LAT,MHLAT,Laterality,C99073,24,SDTM v1.7,MH,,,,,,,,,,,,
DIR,MHDIR,Directionality,C99074,25,SDTM v1.7,MH,,,,,,,,,,,,
PORTOT,MHPORTOT,Portion/Totality,C99075,26,SDTM v1.7,MH,,,,,,,,,,,,
NY,MHCONTRT,No Yes Response,C66742,27,SDTM v1.7,MH,,,,,N; Y,C49487; C49488,,,,,,
,MHTOX,,,28,SDTM v1.7,MH,CTCAE Term,Multiple versions of CTCAE can be used here but is not required by US FDA.,US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
TOXGRV3,MHTOXGR,Common Terminology Criteria for Adverse Events V3.0,C66784,29,SDTM v1.7,MH,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by US FDA.",,,,,,,,,,
TOXGRV4,MHTOXGR,Common Terminology Criteria for Adverse Events V4.0,C87162,30,SDTM v1.7,MH,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA.",,,,,,,,,,
OUT,MHOUT,Outcome of Event,C66768,31,SDTM v1.7,MH,,,,,,,,,,,,
SEVRS,MHSEV,Severity Response,C165643,32,SDTM v1.7,MH,,,,,,,,,,,,
,SUPPMH.QVAL,,,33,TAUG-PTSD v1.0; TAUG-Schizophrenia v1.1; TAUG-MDD v1.0,MH,Code,"TAUG-Schizophrenia v1.1 and TAUG-MDD v1.0 reference 'DSM5CODE' as the NSV short name. The short name was changed to 'MHDSM5CD' in TAUG-Schizophrenia to conform to the rule that the NSV short name should include the 2-letter domain abbreviation. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.psychiatry.org/psychiatrists/practice/dsm/",American Psychiatric Association (APA),"Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)",,,SUPPMH.QNAM EQ "MHDSM5CD",SUPPMH.QLABEL EQ "DSM-5 Code",,,,
,SUPPMH.QVAL,,,34,TAUG-Schizophrenia v1.1; TAUG-MDD v1.0,MH,Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.psychiatry.org/psychiatrists/practice/dsm/",American Psychiatric Association (APA),"Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)",,,SUPPMH.QNAM EQ "DSM4CD",SUPPMH.QLABEL EQ "DSM-IV-TR Code",,,,
,SUPPMH.QVAL,,,35,TAUG-Schizophrenia v1.1; TAUG-MDD v1.0,MH,Axis,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.psychiatry.org/psychiatrists/practice/dsm/",American Psychiatric Association (APA),"Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)",,,SUPPMH.QNAM EQ "DSMAXIS",SUPPMH.QLABEL EQ "DSM-IV-TR Axis",,,,
MODTRN,SUPPMH.QVAL,Mode of Disease Transmission,C127265,36,TAUG-CHCV v1.0,MH,,"This codelist was published in CDISC Terminology version 2019-09-27. \n Note, the NSV MODTR (Mode of Transmission published) in TAUG-HIV v1.0 may be synonymous with this NSV and as such would make use of the same codelist.",,,,,SUPPMH.QNAM EQ "MODINF",SUPPMH.QLABEL EQ "Mode of Infection",,,,
EVAL,SUPPMH.QVAL,Evaluator,C78735,37,TAUG-MDD v1.0,MH,,,,,,,SUPPMH.QNAM EQ "EVAL",SUPPMH.QLABEL EQ "Evaluator",,,,
NY,SUPPMH.QVAL,No Yes Response,C66742,38,TAUG-TBI v1.0,MH,,,,,,,SUPPMH.QNAM EQ "ABDEPIND",SUPPMH.QLABEL EQ "Airbag Deployment Indicator",,,,
NY,SUPPMH.QVAL,No Yes Response,C66742,39,TAUG-TBI v1.0,MH,,,,,,,SUPPMH.QNAM EQ "PRTDVIND",SUPPMH.QLABEL EQ "Protective Device Indicator",,,,
MHEDTTYP,SUPPMH.QVAL,Medical History Event Date Type,C124301,40,TAUG-CHCV v1.0,MH,,,,,,,SUPPMH.QNAM EQ "MHEVTYP",SUPPMH.QLABEL EQ "Medical History Event Type",,,,
MODTRN,SUPPMH.QVAL,Mode of Disease Transmission,C127265,41,TAUG-TB v2.0,MH,,,,,,,SUPPMH.QNAM EQ "MODTRN",SUPPMH.QLABEL EQ "Mode of Transmission",,,,
LOC,SUPPMH.QVAL,Anatomical Location,C74456,42,TAUG-Crohn's Disease v1.0,MH,,,,,,,SUPPMH.QNAM EQ "LOCn",SUPPMH.QLABEL EQ "Location of Event n",,,,
NY,SUPPMH.QVAL,No Yes Response,C66742,43,TAUG-T1D-PDM v2.0,MH,,,,,,,SUPPMH.QNAM EQ "SUABTS",SUPPMH.QLABEL EQ "Supportive Antibody Test Performed",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,CV,,,,,CV,C102605,,,,,,
CVTESTCD,CVTESTCD,Cardiovascular Test Code,C101847,2,SDTMIG v3.3,CV,,,,,,,,,,,,
CVTEST,CVTEST,Cardiovascular Test Name,C101846,3,SDTMIG v3.3,CV,,,,,,,,,,,,
POSITION,CVPOS,Position,C71148,4,SDTMIG v3.3,CV,,,,,,,,,,,,
UNIT,CVORRESU,Unit,C71620,5,SDTMIG v3.3,CV,,,,,,,,,,,,
UNIT,CVSTRESU,Unit,C71620,6,SDTMIG v3.3,CV,,,,,,,,,,,,
ND,CVSTAT,Not Done,C66789,7,SDTMIG v3.3,CV,,,,,,,,,,,,
LOC,CVLOC,Anatomical Location,C74456,8,SDTMIG v3.3,CV,,,,,,,,,,,,
LAT,CVLAT,Laterality,C99073,9,SDTMIG v3.3,CV,,,,,,,,,,,,
DIR,CVDIR,Directionality,C99074,10,SDTMIG v3.3,CV,,,,,,,,,,,,
PORTOT,CVPORTOT,Portion/Totality,C99075,11,SDTM v1.7,CV,,,,,,,,,,,,
METHOD,CVMETHOD,Method,C85492,12,SDTMIG v3.3,CV,,,,,,,,,,,,
NY,CVLOBXFL,No Yes Response,C66742,13,SDTMIG v3.3,CV,,,,,Y,C49488,,,,,,
NY,CVBLFL,No Yes Response,C66742,14,SDTMIG v3.3,CV,,,,,Y,C49488,,,,,,
NY,CVDRVFL,No Yes Response,C66742,15,SDTMIG v3.3,CV,,,,,Y,C49488,,,,,,
EVAL,CVEVAL,Evaluator,C78735,16,SDTMIG v3.3,CV,,,,,,,,,,,,
MEDEVAL,CVEVALID,Medical Evaluator,C96777,17,SDTMIG v3.3,CV,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,18,SDTMIG v3.3,CV,,,,,,,,,,,,
SEVRS,CVSEV,Severity Response,C165643,19,SDTM v1.7,CV,,,,,,,,,,,,
NY,CVACPTFL,No Yes Response,C66742,20,SDTM v1.7,CV,,,,,N; Y,C49487; C49488,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,DA,,,,,DA,C49578,,,,,,
DATESTCD,DATESTCD,Drug Accountability Test Code,C78732,2,SDTMIG v3.3,DA,,,,,,,,,,,,
DATEST,DATEST,Drug Accountability Test Name,C78731,3,SDTMIG v3.3,DA,,,,,,,,,,,,
UNIT,DAORRESU,Unit,C71620,4,SDTMIG v3.3,DA,,,,,,,,,,,,
UNIT,DASTRESU,Unit,C71620,5,SDTMIG v3.3,DA,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,6,SDTMIG v3.3,DA,,,,,,,,,,,,
ND,DASTAT,Not Done,C66789,7,SDTMIG v3.3,DA,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,DD,,,,,DD,C95087,,,,,,
DTHDXCD,DDTESTCD,SDTM Death Diagnosis and Details Test Code,C116108,2,SDTMIG v3.3,DD,,Codelist long name updated in CDISC CT Publication 2018-03-30 from SDTM Death Diagnosis Test Code to SDTM Death Diagnosis and Details Test Code.,,,,,,,,,,
DTHDX,DDTEST,SDTM Death Diagnosis and Details Test Name,C116107,3,SDTMIG v3.3,DD,,Codelist long name updated in CDISC CT Publication 2018-03-30 from SDTM Death Diagnosis Test Name to SDTM Death Diagnosis and Details Test Name.,,,,,,,,,,
EVAL,DDEVAL,Evaluator,C78735,4,SDTMIG v3.3,DD,,,,,,,,,,,,
MEDEVAL,DDEVALID,Medical Evaluator,C96777,5,SDTM v1.7,DD,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,6,SDTM v1.7,DD,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DO,,,,,DO,C102619,,,,,,
DOTESTCD,DOTESTCD,Device Properties Test Code,C111111,2,SDTMIG-MD v1.1,DO,,,,,,,,,,,,
DOTEST,DOTEST,Device Properties Test Name,C111112,3,SDTMIG-MD v1.1,DO,,,,,,,,,,,,
UNIT,DOORRESU,Unit,C71620,4,SDTMIG-MD v1.1,DO,,,,,,,,,,,,
UNIT,DOSTRESU,Unit,C71620,5,SDTM v1.7,DO,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DU,,,,,DU,C102622,,,,,,
DUTESTCD,DUTESTCD,Device-In-Use Test Code,C106483,2,SDTMIG-MD v1.1,DU,,,,,,,,,,,,
DUTEST,DUTEST,Device-In-Use Test Name,C106482,3,SDTMIG-MD v1.1,DU,,,,,,,,,,,,
UNIT,DUORRESU,Unit,C71620,4,SDTMIG-MD v1.1,DU,,,,,,,,,,,,
UNIT,DUSTRESU,Unit,C71620,5,SDTMIG-MD v1.1,DU,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,6,SDTM v1.7,DU,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,EG,,,,,EG,C49626,,,,,,
EGTESTCD,EGTESTCD,ECG Test Code,C71153,2,SDTMIG v3.3,EG,,Based on regular 10-second ECGs,,,,,,,,,,
HETESTCD,EGTESTCD,Holter ECG Test Code,C120523,3,SDTMIG v3.3,EG,,Based on Holter monitoring,,,,,,,,,,
EGTEST,EGTEST,ECG Test Name,C71152,4,SDTMIG v3.3,EG,,Based on regular 10-second ECGs,,,,,,,,,,
HETEST,EGTEST,Holter ECG Test Name,C120524,5,SDTMIG v3.3,EG,,Based on Holter monitoring,,,,,,,,,,
POSITION,EGPOS,Position,C71148,6,SDTMIG v3.3,EG,,,,,,,,,,,,
UNIT,EGORRESU,Unit,C71620,7,SDTMIG v3.3,EG,,,,,,,,,,,,
EGSTRESC,EGSTRESC,ECG Result,C71150,8,SDTMIG v3.3,EG,,Based on regular 10-second ECGs,,,,,,,,,,
HESTRESC,EGSTRESC,Holter ECG Results,C120522,9,SDTMIG v3.3,EG,,Based on Holter monitoring,,,,,,,,,,
NORMABNM,EGSTRESC,Normal Abnormal Response,C101834,10,SDTMIG v3.3,EG,,"Valid when EGTEST EQ ""Interpretation"" and EGTESTCD EQ ""INTP"" and collected results reflect the values in the referenced CDISC CT. Sponsors may use this codelist or extend EGSTRESC with values NORMAL, ABNORMAL, etc. as per sponsor data collection practices.",,,,,,,,,,
UNIT,EGSTRESU,Unit,C71620,11,SDTMIG v3.3,EG,,,,,,,,,,,,
ND,EGSTAT,Not Done,C66789,12,SDTMIG v3.3,EG,,,,,,,,,,,,
NY,EGBLFL,No Yes Response,C66742,13,SDTMIG v3.3,EG,,,,,Y,C49488,,,,,,
NY,EGDRVFL,No Yes Response,C66742,14,SDTMIG v3.3,EG,,,,,Y,C49488,,,,,,
EGLEAD,EGLEAD,ECG Lead,C90013,15,SDTMIG v3.3,EG,,,,,,,,,,,,
EGMETHOD,EGMETHOD,ECG Test Method,C71151,16,SDTMIG v3.3,EG,,,,,,,,,,,,
EVAL,EGEVAL,Evaluator,C78735,17,SDTMIG v3.3,EG,,,,,,,,,,,,
MEDEVAL,EGEVALID,Medical Evaluator,C96777,18,SDTM v1.7,EG,,,,,,,,,,,,
NY,EGACPTFL,No Yes Response,C66742,19,SDTM v1.7,EG,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,20,SDTM v1.7,EG,,,,,,,,,,,,
NY,SUPPEG.QVAL,No Yes Response,C66742,21,SDTMIG v3.3,EG,,,,,N; Y,C49487; C49488,SUPPEG.QNAM EQ "EGCLSIG",SUPPEG.QLABEL EQ "Clinically Significant",,,,
,EGLOINC,,,22,SDTM v1.7,EG,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
NY,SUPPEG.QVAL,No Yes Response,C66742,23,TAUG-QT v1.0,EG,,"This supplemental qualifier flags EG records used in calculating a coefficient represented in the QT domain, a custom domain which has not been added to the SDTMIG.",,,Y,C49488,SUPPEG.QNAM EQ "QTCCIFL",SUPPEG.QLABEL EQ "Individ QT Correction Coefficient Flag",,,,
NY,SUPPEG.QVAL,No Yes Response,C66742,24,TAUG-QT v1.0,EG,,"This supplemental qualifier flags EG records used in calculating a coefficient represented in the QT domain, a custom domain which has not been added to the SDTMIG.",,,Y,C49488,SUPPEG.QNAM EQ "QTCCNFL",SUPPEG.QLABEL EQ "Populatn QT Correction Coefficient Flag",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,FA,,,,,FA,C85442,,,,text,,
FATESTCD,FATESTCD,Findings About Test Code,C101832,2,SDTMIG v3.3,FA,,,,,,,,,,text,,
FATEST,FATEST,Findings About Test Name,C101833,3,SDTMIG v3.3,FA,,,,,,,,,,text,,
NY,FASTRESC,No Yes Response,C66742,4,TAUG-Asthma v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Asthma Findings About Test Code (ASFATSCD) and Asthma Findings About Test (ASFATS) CT codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,5,TAUG-CDAD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the CDAD Findings About Test Code (CDFATSCD) and CDAD Findings About Test Name (CDFATS) codelist, respectively.",,,,,FATESTCD EQ "EPSDNUM",FATEST EQ "Number of Episodes",C124281,integer,C124281,
,FASTRESC,,,6,TAUG-CDAD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the CDAD Findings About Test Code (CDFATSCD) and CDAD Findings About Test Name (CDFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,7,TAUG-CDAD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the CDAD Findings About Test Code (CDFATSCD) and CDAD Findings About Test Name (CDFATS) codelist, respectively.",,,,,FATESTCD EQ "VOL",FATEST EQ "Volume",C74720,float,C74720,
,FASTRESC,,,8,TAUG-COPD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COPD Findings About Test Code (CPFATSCD) and COPD Findings About Test Name (CPFATS) codelist, respectively.",,,,,FATESTCD EQ "CUMEXP",FATEST EQ "Cumulative Exposure",C94596,integer,C94596,
,FASTRESC,,,9,TAUG-COPD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COPD Findings About Test Code (CPFATSCD) and COPD Findings About Test Name (CPFATS) codelist, respectively.",,,,,FATESTCD EQ "EPMLDNUM",FATEST EQ "Number of Mild Episodes",C124328,integer,C124328,
,FASTRESC,,,10,TAUG-COPD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COPD Findings About Test Code (CPFATSCD) and COPD Findings About Test Name (CPFATS) codelist, respectively.",,,,,FATESTCD EQ "EPMODNUM",FATEST EQ "Number of Moderate Episodes",C124329,integer,C124329,
,FASTRESC,,,11,TAUG-COPD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COPD Findings About Test Code (CPFATSCD) and COPD Findings About Test Name (CPFATS) codelist, respectively.",,,,,FATESTCD EQ "EPSEVNUM",FATEST EQ "Number of Severe Episodes",C124330,integer,C124330,
,FASTRESC,,,12,TAUG-COVID-19 v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COVID-19 Findings About Test Code (C19FATCD) and COVID-19 Findings About Test Name (C19FAT) codelist, respectively.",,,,,FATESTCD EQ "EPSDNUM",FATEST EQ "Number of Episodes",C124281,integer,C124281,
NY,FASTRESC,No Yes Response,C66742,13,TAUG-COVID-19 v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COVID-19 Findings About Test Code (C19FATCD) and COVID-19 Findings About Test Name (C19FAT) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,14,TAUG-COVID-19 v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the COVID-19 Findings About Test Code (C19FATCD) and COVID-19 Findings About Test Name (C19FAT) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,15,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "ABSCNUM",FATEST EQ "Number of Abscesses",C181313,integer,C181313,
,FASTRESC,,,16,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "AGESYMST",FATEST EQ "Age Symptoms Started",C174273,integer,C174273,
NY,FASTRESC,No Yes Response,C66742,17,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "BIOPSIND",FATEST EQ "Biopsy Specimen Taken Indicator",C181316,text,C181316,
,FASTRESC,,,18,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "BIOPSNUM",FATEST EQ "Number of Biopsy Specimens Taken",C181317,integer,C181317,
,FASTRESC,,,19,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "BPSPTHAP",FATEST EQ "Pathologic Appearance of Biopsy Site",C181318,text,C181318,
NY,FASTRESC,No Yes Response,C66742,20,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "DCDEPIND",FATEST EQ "Unable to Discon Dependent Indicator",C176284,text,C176284,
,FASTRESC,,,21,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "DEVPNUM",FATEST EQ "Number of Devices Present",C176277,integer,C176277,
,FASTRESC,,,22,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "DVCINSN",FATEST EQ "Number of Devices Inserted",C174280,integer,C174280,
NY,FASTRESC,No Yes Response,C66742,23,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "EXETRIND",FATEST EQ "Expected Efficacious Treatment Reg Ind",C181310,text,C181310,
,FASTRESC,,,24,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "EXTRSCT",FATEST EQ "Extent of Resection",C157443,text,C157443,
,FASTRESC,,,25,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "FISTATYP",FATEST EQ "Fistula Anatomical Type",C181314,text,C181314,
,FASTRESC,,,26,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "FISTNUM",FATEST EQ "Number of Fistulas",C181312,integer,C181312,
,FASTRESC,,,27,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "FNDOSAMT",FATEST EQ "Final Dose Amount",C176280,integer,C176280,
,FASTRESC,,,28,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "FNDOSFRQ",FATEST EQ "Frequency of Final Dose Amount",C176281,text,C176281,
NY,FASTRESC,No Yes Response,C66742,29,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "ICJRIND",FATEST EQ "Ileocecal Junction Removed Indicator",C174279,text,C174279,
,FASTRESC,,,30,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "LENRSCT",FATEST EQ "Length of Resection",C174278,integer,C174278,
,FASTRESC,,,31,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "LESNUM",FATEST EQ "Number of Lesions",C174277,integer,C174277,
,FASTRESC,,,32,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "MXDOSAMT",FATEST EQ "Maximum Dose Amount",C176278,integer,C176278,
,FASTRESC,,,33,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "MXDOSFRQ",FATEST EQ "Frequency of Maximum Dose Amount",C176279,text,C176279,
,FASTRESC,,,34,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "PLLDIAM",FATEST EQ "Longest Diameter of Primary Lesion",C181311,integer,C181311,
,FASTRESC,,,35,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "PLLOC",FATEST EQ "Anatomical Location of Primary Lesion",C181315,text,C181315,
,FASTRESC,,,36,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "PROCPRFN",FATEST EQ "Number of Procedures Performed",C174228,integer,C174228,
NY,FASTRESC,No Yes Response,C66742,37,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "RLDEPIND",FATEST EQ "Relapse after Discon Dependent Indicator",C176283,text,C176283,
NY,FASTRESC,No Yes Response,C66742,38,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "SBDEPIND",FATEST EQ "Substance Dependence Indicator",C176285,text,C176285,
,FASTRESC,,,39,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,40,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "SSDISC",FATEST EQ "Sign/Symptom Leading to Discontinuation",C174281,text,C174281,
,FASTRESC,,,41,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,,,FATESTCD EQ "STRCTNUM",FATEST EQ "Number of Strictures",C174274,integer,C174274,
NY,FASTRESC,No Yes Response,C66742,42,TAUG-Crohn v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Crohn's Disease Findings About Test Code (CRFATSCD) and Crohn's Disease Findings About Test Name (CRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "TPDEPIND",FATEST EQ "Unable to Taper Dependent Indicator",C176282,text,C176282,
,FASTRESC,,,43,TAUG-DKD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Diabetic Kidney Disease Findings About Test Code (DKFATSCD) and Diabetic Kidney Disease Findings About Test Name (DKFATS) codelist, respectively.",,,,,FATESTCD EQ "EVENTNUM",FATEST EQ "Number of Events",C130057,integer,C130057,
,FASTRESC,,,44,TAUG-DMD v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Duchenne Muscular Dystrophy Findings About Test Code (DMFATSCD) and Duchenne Muscular Dystrophy Findings About Test Name (DMFATS) codelist, respectively.",,,,,FATESTCD EQ "AGEFTUSE",FATEST EQ "Age at Full-Time Use",C139175,integer,C139175,
,FASTRESC,,,45,TAUG-Ebola v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Ebola Virus Findings About Test Code (EBFATSCD) and Ebola Virus Findings About Test Name (EBFATS) codelist, respectively.",,,,,FATESTCD EQ "DIAMETER",FATEST EQ "Diameter",C25285,integer,C25285,
NY,FASTRESC,No Yes Response,C66742,46,TAUG-Ebola v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Ebola Virus Findings About Test Code (EBFATSCD) and Ebola Virus Findings About Test Name (EBFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,47,TAUG-Ebola v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Ebola Virus Findings About Test Code (EBFATSCD) and Ebola Virus Findings About Test Name (EBFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
NY,FASTRESC,No Yes Response,C66742,48,TAUG-LuCa v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Lung Cancer Findings About Test Code (LUFATSCD) and Lung Cancer Findings About Test Name (LUFATS) codelist, respectively.",,,,,FATESTCD EQ "ORCANIND",FATEST EQ "Origin of Cancer Known Ind",C154860,text,C154860,
NY,FASTRESC,No Yes Response,C66742,49,TAUG-LuCa v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Lung Cancer Findings About Test Code (LUFATSCD) and Lung Cancer Findings About Test Name (LUFATS) codelist, respectively.",,,,,FATESTCD EQ "RESCTIND",FATEST EQ "Resected Tumor Ind",C154861,text,C154861,
NY,FASTRESC,No Yes Response,C66742,50,TAUG-Malaria v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Malaria Findings About Test Code (MRFATSCD) and Malaria Findings About Test Name (MRFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,51,TAUG-Malaria v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Malaria Findings About Test Code (MRFATSCD) and Malaria Findings About Test Name (MRFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,52,TAUG-MS v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Multiple Sclerosis Findings About Test Code (MSFATSCD) and Multiple Sclerosis Findings About Test Name (MSFATS) codelist, respectively.",,,,,FATESTCD EQ "DXCRITMT",FATEST EQ "Diagnostic Criteria Met",C117883,text,C117883,
NY,FASTRESC,No Yes Response,C66742,53,TAUG-MS v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Multiple Sclerosis Findings About Test Code (MSFATSCD) and Multiple Sclerosis Findings About Test Name (MSFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "LOCONSET",FATEST EQ "Localization of Onset",C117884,text,C117884,
,FASTRESC,,,54,TAUG-MS v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Multiple Sclerosis Findings About Test Code (MSFATSCD) and Multiple Sclerosis Findings About Test Name (MSFATS) codelist, respectively.",,,,,FATESTCD EQ "OUNIMULT",FATEST EQ "Onset Unifocal or Multifocal",C117885,text,C117885,
,FASTRESC,,,55,TAUG-Nutrition v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Nutrition Findings About Test Code (NTFATSCD) and Nutrition Findings About Test Name (NTFATS) codelist, respectively.",,,,,FATESTCD EQ "EVENTFRQ",FATEST EQ "Event Frequency",C25515,integer,C25515,
NY,FASTRESC,No Yes Response,C66742,56,TAUG-Nutrition v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Nutrition Findings About Test Code (NTFATSCD) and Nutrition Findings About Test Name (NTFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,57,TAUG-Nutrition v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Nutrition Findings About Test Code (NTFATSCD) and Nutrition Findings About Test Name (NTFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,58,TAUG-PanCan v1.0,FA,Title,"The referenced term for FATESTCD and FATEST is a member of the Pancreatic Cancer Findings About Test Code (PAFATSCD) and Pancreatic Cancer Findings About Test Name (PAFATS) codelist, respectively. \n Link to general information about the cited external dictionary, accessed 2022-07-28: https://www.who.int/standards/classifications/other-classifications/international-classification-of-diseases-for-oncology/",World Health Organization International Agency for Research on Cancer (WHO IARC),"International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3)",,,FATESTCD EQ "PRYSTUOG",FATEST EQ "Primary Site of Tumor Origin",C179451,text,C179451,
,FASTRESC,,,59,TAUG-Psoriasis v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Psoriasis Findings About Test Code (PSFATSCD) and Psoriasis Findings About Test Name (PSFATS) codelist, respectively.",,,,,FATESTCD EQ "QOLIMP",FATEST EQ "QOL Impact",C170617,integer,C170617,
,FASTRESC,,,60,TAUG-Psoriasis v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Psoriasis Findings About Test Code (PSFATSCD) and Psoriasis Findings About Test Name (PSFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,61,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "ACUTSTRS",FATEST EQ "Most Severe Acute Stressor",C124437,text,C124437,
,FASTRESC,,,62,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "AGEEPSD1",FATEST EQ "Age At First Episode",C124438,integer,C124438,
,FASTRESC,,,63,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "AGEHOSP1",FATEST EQ "Age At First Hospitalization",C124439,integer,C124439,
,FASTRESC,,,64,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "AGETRT1",FATEST EQ "Age At First Treatment",C124440,integer,C124440,
,FASTRESC,,,65,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "CHRNSTRS",FATEST EQ "Most Severe Chronic Stressor",C124441,text,C124441,
NY,FASTRESC,No Yes Response,C66742,66,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "CLININD",FATEST EQ "Clinic Stay Indicator",C124442,text,C124442,
,FASTRESC,,,67,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "EPSDNUM",FATEST EQ "Number of Episodes",C124281,integer,C124281,
,FASTRESC,,,68,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "HOSPNUM",FATEST EQ "Number Of Hospitalizations",C124443,integer,C124443,
,FASTRESC,,,69,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "LONGCRSE",FATEST EQ "Longitudinal Course",C35461,text,C35461,
NY,FASTRESC,No Yes Response,C66742,70,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,71,TAUG-Schizophrenia v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Schizophrenia Findings About Test Code (SZFATSCD) and Schizophrenia Findings About Test Name (SZFATS) codelist, respectively.",,,,,FATESTCD EQ "TRTSETT",FATEST EQ "Treatment Setting",C124444,text,C124444,
,FASTRESC,,,72,TAUG-TB v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Tuberculosis Findings About Test Code (TBFATSCD) and Tuberculosis Findings About Test Name (TBFATS) codelist, respectively.",,,,,FATESTCD EQ "DRSTAT",FATEST EQ "Drug Resistance Status",C102626,text,C102626,
,FASTRESC,,,73,TAUG-TB v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Tuberculosis Findings About Test Code (TBFATSCD) and Tuberculosis Findings About Test Name (TBFATS) codelist, respectively.",,,,,FATESTCD EQ "LDIAM",FATEST EQ "Longest Diameter",C96684,integer,C96684,
NY,FASTRESC,No Yes Response,C66742,74,TAUG-TB v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Tuberculosis Findings About Test Code (TBFATSCD) and Tuberculosis Findings About Test Name (TBFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
,FASTRESC,,,75,TAUG-TB v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Tuberculosis Findings About Test Code (TBFATSCD) and Tuberculosis Findings About Test Name (TBFATS) codelist, respectively.",,,,,FATESTCD EQ "TOTNUM",FATEST EQ "Total Number",C127787,integer,C127787,
D1FATSCD,FATESTCD,Type 1 Diabetes Findings About Test Code,C163027,76,TAUG-T1D v1.0,FA,,,,,,,,,,text,,
D1FATS,FATEST,Type 1 Diabetes Findings About Test Name,C163028,77,TAUG-T1D v1.0,FA,,,,,,,,,,text,,
,FASTRESC,,,78,TAUG-T1D-PDM v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "ACNDEV",FATEST EQ "Action Taken With Device",C117037,text,C117037,
,FASTRESC,,,79,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "ACNSBJ",FATEST EQ "Action Taken With Subject",C163412,text,C163412,
,FASTRESC,,,80,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "ALCDRKN",FATEST EQ "Number of Alcoholic Drinks",C184464,float,C184464,
,FASTRESC,,,81,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "CALBURN",FATEST EQ "Calories Burned",C172476,integer,C172476,
,FASTRESC,,,82,TAUG-T1D-PDM v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "CUMEXP",FATEST EQ "Cumulative Exposure",C94596,integer,C94596,
,FASTRESC,,,83,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DACARO",FATEST EQ "Dietary Alpha Carotene",C184449,float,C184449,
,FASTRESC,,,84,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DADDSUG",FATEST EQ "Dietary Added Sugar",C172463,float,C172463,
,FASTRESC,,,85,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DALCOHOL",FATEST EQ "Dietary Alcohol",C184463,float,C184463,
,FASTRESC,,,86,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DARAC",FATEST EQ "Dietary Arachidonic Acid",C184441,float,C184441,
,FASTRESC,,,87,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DATOCO",FATEST EQ "Dietary Alpha Tocopherol",C184450,float,C184450,
,FASTRESC,,,88,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DAVITB12",FATEST EQ "Dietary Added Vitamin B12",C184461,float,C184461,
,FASTRESC,,,89,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DAVITE",FATEST EQ "Dietary Added Vitamin E",C184462,float,C184462,
,FASTRESC,,,90,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DBCARO",FATEST EQ "Dietary Beta Carotene",C184451,float,C184451,
,FASTRESC,,,91,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DBEANPEA",FATEST EQ "Dietary Beans and Peas",C184465,float,C184465,
,FASTRESC,,,92,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DBUTR",FATEST EQ "Dietary Butyric Acid",C184446,float,C184446,
,FASTRESC,,,93,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCA",FATEST EQ "Dietary Calcium",C184453,float,C184453,
,FASTRESC,,,94,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCAFFEIN",FATEST EQ "Dietary Caffeine",C184452,float,C184452,
,FASTRESC,,,95,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCAL",FATEST EQ "Dietary Calories",C172464,float,C172464,
,FASTRESC,,,96,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCAPO",FATEST EQ "Dietary Caproic Acid",C184447,float,C184447,
,FASTRESC,,,97,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCAPR",FATEST EQ "Dietary Capric Acid",C184430,float,C184430,
,FASTRESC,,,98,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCAPY",FATEST EQ "Dietary Caprylic Acid",C184448,float,C184448,
,FASTRESC,,,99,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCARBT",FATEST EQ "Dietary Total Carbohydrate",C172461,float,C172461,
,FASTRESC,,,100,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCHEESE",FATEST EQ "Dietary Cheese",C184454,float,C184454,
,FASTRESC,,,101,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCHOLEST",FATEST EQ "Dietary Cholesterol",C184466,float,C184466,
,FASTRESC,,,102,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCHOLINE",FATEST EQ "Dietary Choline",C184467,float,C184467,
,FASTRESC,,,103,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCITMELB","FATEST EQ ""Dietary Citrus, Melons, and Berries""",C184468,float,C184468,
,FASTRESC,,,104,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCPND",FATEST EQ "Dietary Clupanodonic Acid",C184444,float,C184444,
,FASTRESC,,,105,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCRXANB",FATEST EQ "Dietary Beta-Cryptoxanthin",C186015,float,C186015,
,FASTRESC,,,106,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DCU",FATEST EQ "Dietary Copper",C184455,float,C184455,
,FASTRESC,,,107,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DDAIRYT",FATEST EQ "Dietary Total Dairy",C184337,float,C184337,
,FASTRESC,,,108,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DDCHX",FATEST EQ "Dietary Docosahexaenoic Acid",C184445,float,C184445,
,FASTRESC,,,109,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DEGGS",FATEST EQ "Dietary Eggs",C184471,float,C184471,
,FASTRESC,,,110,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DERUC",FATEST EQ "Dietary Erucic Acid",C184443,float,C184443,
,FASTRESC,,,111,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFATM","FATEST EQ ""Dietary Fat, Monounsaturated""",C172471,float,C172471,
,FASTRESC,,,112,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFATP","FATEST EQ ""Dietary Fat, Polyunsaturated""",C172472,float,C172472,
,FASTRESC,,,113,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFATS","FATEST EQ ""Dietary Fat, Saturated""",C172470,float,C172470,
,FASTRESC,,,114,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFATT","FATEST EQ ""Dietary Fat, Total""",C172460,float,C172460,
,FASTRESC,,,115,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFE",FATEST EQ "Dietary Iron",C184456,float,C184456,
,FASTRESC,,,116,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFEQ",FATEST EQ "Dietary Folate Equivalents",C186016,float,C186016,
,FASTRESC,,,117,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFIBER",FATEST EQ "Dietary Fiber",C172469,float,C172469,
,FASTRESC,,,118,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFOLFD",FATEST EQ "Dietary Food Folate",C186017,float,C186017,
,FASTRESC,,,119,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFOLIC",FATEST EQ "Dietary Folic Acid",C186018,float,C186018,
,FASTRESC,,,120,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFOLTOT",FATEST EQ "Dietary Total Folate",C186019,float,C186019,
,FASTRESC,,,121,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFRTJUCE",FATEST EQ "Dietary Fruit Juice",C184472,float,C184472,
,FASTRESC,,,122,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DFRUIT",FATEST EQ "Dietary Fruit",C172465,float,C172465,
,FASTRESC,,,123,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DGADL",FATEST EQ "Dietary Gadoleic Acid",C184440,float,C184440,
,FASTRESC,,,124,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DGRAIN",FATEST EQ "Dietary Grain",C172467,float,C172467,
,FASTRESC,,,125,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DGRAINRF","FATEST EQ ""Dietary Grain, Refined""",C184484,float,C184484,
,FASTRESC,,,126,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DGRAINWH",FATEST EQ "Dietary Whole Grains",C184502,float,C184502,
,FASTRESC,,,127,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DISPAMT",FATEST EQ "Dispensed Amount",C78721,float,C78721,
,FASTRESC,,,128,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DISTANCE",FATEST EQ "Distance",C25167,float,C25167,
,FASTRESC,,,129,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DK",FATEST EQ "Dietary Potassium",C184457,float,C184457,
,FASTRESC,,,130,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DLAUR",FATEST EQ "Dietary Lauric Acid",C184431,float,C184431,
,FASTRESC,,,131,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DLINO",FATEST EQ "Dietary Linoleic Acid",C184437,float,C184437,
,FASTRESC,,,132,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DLINOL",FATEST EQ "Dietary Linolenic Acid",C184438,float,C184438,
,FASTRESC,,,133,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DLUTZXAN",FATEST EQ "Dietary Lutein and Zeaxanthin",C184473,float,C184473,
,FASTRESC,,,134,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DLYCOP",FATEST EQ "Dietary Lycopene",C184474,float,C184474,
,FASTRESC,,,135,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMEAT",FATEST EQ "Dietary Meat",C172468,float,C172468,
,FASTRESC,,,136,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMEATCUR","FATEST EQ ""Dietary Meat, Cured""",C184469,float,C184469,
,FASTRESC,,,137,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMEATORG","FATEST EQ ""Dietary Meat, Organ""",C184480,float,C184480,
,FASTRESC,,,138,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMEATPLS","FATEST EQ ""Dietary Meat, Poultry, and Seafood""",C184504,float,C184504,
,FASTRESC,,,139,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMG",FATEST EQ "Dietary Magnesium",C172462,float,C172462,
,FASTRESC,,,140,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMILK",FATEST EQ "Dietary Milk",C184475,float,C184475,
,FASTRESC,,,141,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMOISTUR",FATEST EQ "Dietary Moisture",C184476,float,C184476,
,FASTRESC,,,142,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DMYRST",FATEST EQ "Dietary Myristic Acid",C184432,float,C184432,
,FASTRESC,,,143,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DNA",FATEST EQ "Dietary Sodium",C184459,float,C184459,
,FASTRESC,,,144,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DNIACIN",FATEST EQ "Dietary Niacin",C184477,float,C184477,
,FASTRESC,,,145,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DNUTSEED",FATEST EQ "Dietary Nuts and Seeds",C184478,float,C184478,
,FASTRESC,,,146,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DOILS",FATEST EQ "Dietary Oils",C184479,float,C184479,
,FASTRESC,,,147,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DOLE",FATEST EQ "Dietary Oleic Acid",C184436,float,C184436,
,FASTRESC,,,148,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DP",FATEST EQ "Dietary Phosphorus",C184481,float,C184481,
,FASTRESC,,,149,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPALM",FATEST EQ "Dietary Palmitic Acid",C184433,float,C184433,
,FASTRESC,,,150,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPALMO",FATEST EQ "Dietary Palmitoleic Acid",C184434,float,C184434,
,FASTRESC,,,151,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPARN",FATEST EQ "Dietary Parinaric Acid",C184439,float,C184439,
,FASTRESC,,,152,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPOTATO",FATEST EQ "Dietary Potatoes",C184482,float,C184482,
,FASTRESC,,,153,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPOULTRY",FATEST EQ "Dietary Poultry",C184483,float,C184483,
,FASTRESC,,,154,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPROT",FATEST EQ "Dietary Protein",C172459,float,C172459,
,FASTRESC,,,155,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DPROTFD",FATEST EQ "Dietary Protein Foods",C184494,float,C184494,
,FASTRESC,,,156,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DRETINOL",FATEST EQ "Dietary Retinol",C184485,float,C184485,
,FASTRESC,,,157,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DRIBFLVN",FATEST EQ "Dietary Riboflavin",C184486,float,C184486,
,FASTRESC,,,158,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSE",FATEST EQ "Dietary Selenium",C184458,float,C184458,
,FASTRESC,,,159,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSFHN3FA",FATEST EQ "Dietary Seafood High in n-3 Fatty Acids",C184487,float,C184487,
,FASTRESC,,,160,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSFLN3FA",FATEST EQ "Dietary Seafood Low in n-3 Fatty Acids",C184488,float,C184488,
,FASTRESC,,,161,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSLDFAT",FATEST EQ "Dietary Solid Fats",C184489,float,C184489,
,FASTRESC,,,162,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSOYPROD",FATEST EQ "Dietary Soy Products",C184490,float,C184490,
,FASTRESC,,,163,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSTER",FATEST EQ "Dietary Stearic Acid",C184435,float,C184435,
,FASTRESC,,,164,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DSUGART",FATEST EQ "Dietary Total Sugars",C184338,float,C184338,
,FASTRESC,,,165,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DTHEOBR",FATEST EQ "Dietary Theobromine",C184491,float,C184491,
,FASTRESC,,,166,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DTHIAMIN",FATEST EQ "Dietary Thiamine",C184492,float,C184492,
,FASTRESC,,,167,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DTMND",FATEST EQ "Dietary Timnodonic Acid",C184442,float,C184442,
,FASTRESC,,,168,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DTOMATO",FATEST EQ "Dietary Tomatoes",C184493,float,C184493,
,FASTRESC,,,169,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVEG",FATEST EQ "Dietary Vegetable",C172466,float,C172466,
,FASTRESC,,,170,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVEGDG","FATEST EQ ""Dietary Vegetables, Dark Green""",C184470,float,C184470,
,FASTRESC,,,171,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVEGRO","FATEST EQ ""Dietary Vegetables, Red and Orange""",C184495,float,C184495,
,FASTRESC,,,172,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVEGSTAR","FATEST EQ ""Dietary Vegetables, Starchy""",C184496,float,C184496,
,FASTRESC,,,173,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVITA",FATEST EQ "Dietary Vitamin A",C184497,float,C184497,
,FASTRESC,,,174,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVITB12",FATEST EQ "Dietary Vitamin B12",C184353,float,C184353,
,FASTRESC,,,175,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVITB6",FATEST EQ "Dietary Vitamin B6",C184498,float,C184498,
,FASTRESC,,,176,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVITC",FATEST EQ "Dietary Vitamin C",C184499,float,C184499,
,FASTRESC,,,177,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVITD",FATEST EQ "Dietary Vitamin D",C184500,float,C184500,
,FASTRESC,,,178,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DVITK",FATEST EQ "Dietary Vitamin K",C184501,float,C184501,
,FASTRESC,,,179,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DYOGURT",FATEST EQ "Dietary Yogurt",C184503,float,C184503,
,FASTRESC,,,180,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "DZN",FATEST EQ "Dietary Zinc",C184460,float,C184460,
,FASTRESC,,,181,TAUG-T1D-PDM v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "EPSDNUM",FATEST EQ "Number of Episodes",C124281,integer,C124281,
,FASTRESC,,,182,Type 1 Diabetes Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "ESTWT",FATEST EQ "Estimated Weight",C174282,float,C174282,
,FASTRESC,,,183,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "EXCDUR",FATEST EQ "Exercise Duration",C172475,durationDatetime,C172475,
,FASTRESC,,,184,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "EXCINTSY",FATEST EQ "Exercise Intensity",C172473,text,C172473,
,FASTRESC,,,185,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "EXCMPLNC",FATEST EQ "Exercise Compliance",C172474,integer,C172474,
,FASTRESC,,,186,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "LAPCOMPN",FATEST EQ "Number of Laps Completed",C172478,float,C172478,
,FASTRESC,,,187,TAUG-T1D-PDM v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "PPTFCT",FATEST EQ "Precipitating Factor",C163413,text,C163413,
,FASTRESC,,,188,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "PREPAMT",FATEST EQ "Prepared Amount",C170562,float,C170562,
,FASTRESC,,,189,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "REMAMT",FATEST EQ "Remaining Amount",C170563,float,C170563,
,FASTRESC,,,190,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "RETAMT",FATEST EQ "Returned Amount",C78722,float,C78722,
,FASTRESC,,,191,TAUG-T1D-PDM v2.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "RLDEV",FATEST EQ "Relationship to Device",C163414,text,C163414,
,FASTRESC,,,192,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "SPEED",FATEST EQ "Speed",C41146,integer,C41146,
,FASTRESC,,,193,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "STEPSTN",FATEST EQ "Number of Steps Taken",C172479,integer,C172479,
,FASTRESC,,,194,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "TTIMPAUS",FATEST EQ "Total Time Paused",C172477,integer,C172477,
,FASTRESC,,,195,TAUG-T1D-ENM v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Type 1 Diabetes Findings About Test Code (D1FATSCD) and Type 1 Diabetes Findings About Test Name (D1FATS) codelist, respectively.",,,,,FATESTCD EQ "TTIMPHAC",FATEST EQ "Total Time Physically Active",C172480,integer,C172480,
,FASTRESC,,,196,TAUG-Vaccines v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,,,FATESTCD EQ "EPSDNUM",FATEST EQ "Number of Episodes",C124281,integer,C124281,
,FASTRESC,,,197,TAUG-Vaccines v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,,,FATESTCD EQ "LDIAM",FATEST EQ "Longest Diameter",C96684,integer,C96684,
,FASTRESC,,,198,Vaccines Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,,,FATESTCD EQ "NDLGAUGE",FATEST EQ "Needle Gauge",C101687,integer,C101687,
NY,FASTRESC,No Yes Response,C66742,199,TAUG-Vaccines v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,N; Y,C49487; C49488,FATESTCD EQ "OCCUR",FATEST EQ "Occurrence Indicator",C127786,text,C127786,
NY,FASTRESC,No Yes Response,C66742,200,Vaccines Therapeutic Area,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,,,FATESTCD EQ "PDAIND",FATEST EQ "Prevents Daily Activities Indicator",C184724,text,C184724,
,FASTRESC,,,201,TAUG-Vaccines v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,,,FATESTCD EQ "SEV",FATEST EQ "Severity/Intensity",C25676,text,C25676,
,FASTRESC,,,202,TAUG-Vaccines v1.1,FA,,"The referenced term for FATESTCD and FATEST is a member of the Vaccines Findings About Test Code (VNFATSCD) and Vaccines Findings About Test Name (VNFATS) codelist, respectively.",,,,,FATESTCD EQ "TOXGR",FATEST EQ "Toxicity Grade",C82528,text,C82528,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,203,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,TYPE 1 MYOCARDIAL INFARCTION; TYPE 2 MYOCARDIAL INFARCTION; TYPE 3 MYOCARDIAL INFARCTION; TYPE 4A MYOCARDIAL INFARCTION; TYPE 4B MYOCARDIAL INFARCTION; TYPE 4C MYOCARDIAL INFARCTION; TYPE 5 MYOCARDIAL INFARCTION,C119220; C119221; C119222; C119223; C119224; C119225; C119226,FATESTCD EQ "ACMITYPE",FATEST EQ "Acute Myocardial Infarction Type",C118936,text,C118936,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,204,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,ANGIOGRAPHY; AUTOPSY,C20080; C25153,FATESTCD EQ "CATMTHID",FATEST EQ "Coronary Artery Thrombosis Method Ident",C119229,text,C119229,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,205,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,HEART FAILURE HOSPITALIZATION; URGENT HEART FAILURE VISIT,C119204; C119227,FATESTCD EQ "HETYPE",FATEST EQ "Health Care Encounter Type",C119231,text,C119231,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,206,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,INCREASE IN HEART FAILURE BIOMARKER; INVASIVE DIAGNOSTIC EVIDENCE OF HEART FAILURE; NON-INVASIVE DIAGNOSTIC EVIDENCE OF HEART FAILURE; RADIOLOGICAL EVIDENCE OF PULMONARY CONGESTION,C119205; C119209; C119215; C119217,FATESTCD EQ "HFLBFNW",FATEST EQ "Heart Failure New/Worsening Lab Findings",C119232,text,C119232,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,207,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,CLINICALLY SIGNIFICANT OR RAPID WEIGHT GAIN; INCREASED JUGULAR VENOUS PRESSURE OR HEPATOJUGULAR REFLUX; INCREASING ABDOMINAL DISTENTION OR ASCITES; PERIPHERAL EDEMA; PULMONARY RALES/CRACKLES/CREPITATIONS; S3 GALLOP,C119200; C119206; C2885; C78262; C119216; C61455,FATESTCD EQ "HFPEFNW",FATEST EQ "Heart Failure New/Worsening PE Findings",C119232,text,C119232,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,208,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,"AUGMENTATION OF ORAL DIURETIC THERAPY; INTRAVENOUS DIURETIC, INOTROPE, OR VASODILATOR THERAPY; MECHANICAL OR SURGICAL INTERVENTION",C119199; C119208; C119212,FATESTCD EQ "HFTHERIN","FATEST EQ ""Heart Failure Therapy, Intensification""",C119234,text,C119234,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,209,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,CORONARY LESION ON ANGIOGRAPHY; CORONARY REVASCULARIZATION; INDUCIBLE MYOCARDIAL ISCHEMIA; RESTING ECG CHANGES,C119201; C119202; C119207; C119218,FATESTCD EQ "ISCETYP",FATEST EQ "Ischemic Evidence Type",C119236,text,C119236,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,210,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,NEW LOSS OF VIABLE MYOCARDIUM; NEW REGIONAL WALL MOTION ABNORMALITY,C119213; C119214,FATESTCD EQ "NINVIMGC",FATEST EQ "Non-Invasive Imaging Change",C123443,text,C123443,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,211,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,DECREASED EXERCISE TOLERANCE; DYSPNEA; FATIGUE; VOLUME OVERLOAD; WORSENED END-ORGAN PERFUSION,C119203; C2998; C3036; C50591; C119228,FATESTCD EQ "NWSYMP",FATEST EQ "New or Worsening Symptoms",C119238,text,C119238,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,212,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,LOSS OF A SIDE BRANCH; LOSS OF MAJOR CORONARY; SLOW-FLOW/NO-FLOW/EMBOLIZATION,C119210; C119211; C119219,FATESTCD EQ "PCIAAC",FATEST EQ "PCI Acute Angiographic Complication",C119239,text,C119239,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,213,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,STENT THROMBOSIS ARC ACUTE; STENT THROMBOSIS ARC LATE; STENT THROMBOSIS ARC SUBACUTE; STENT THROMBOSIS ARC VERY LATE,C123439; C123440; C123441; C123442,FATESTCD EQ "STCTIMNG","FATEST EQ ""Stent Thrombosis, Coronary, ARC Timing""",C123424,text,C123424,
CVFARS,FASTRESC,Cardiovascular Findings About Results,C119016,214,TAUG-CV v1.0,FA,,"The referenced term for FATESTCD and FATEST is a member of the Cardiovascular Findings About Test Code (CVFATSCD) and Cardiovascular Findings About Test Name (CVFATS) codelist, respectively.",,,HEMORRHAGIC STROKE; ISCHEMIC STROKE; UNDETERMINED STROKE,C95803; C95802; C3390,FATESTCD EQ "STROKTYP",FATEST EQ "Stroke Type",C119579,text,C119579,
UNIT,FAORRESU,Unit,C71620,215,SDTMIG v3.3,FA,,,,,,,,,,text,,
UNIT,FASTRESU,Unit,C71620,216,SDTMIG v3.3,FA,,,,,,,,,,text,,
ND,FASTAT,Not Done,C66789,217,SDTMIG v3.3,FA,,,,,,,,,,text,,
LOC,FALOC,Anatomical Location,C74456,218,SDTMIG v3.3,FA,,,,,,,,,,text,,
LAT,FALAT,Laterality,C99073,219,SDTMIG v3.3,FA,,,,,,,,,,text,,
NY,FALOBXFL,No Yes Response,C66742,220,SDTMIG v3.3,FA,,,,,Y,C49488,,,,text,,
NY,FABLFL,No Yes Response,C66742,221,SDTMIG v3.3,FA,,,,,Y,C49488,,,,text,,
EVAL,FAEVAL,Evaluator,C78735,222,SDTMIG v3.3,FA,,,,,,,,,,text,,
EPOCH,EPOCH,Epoch,C99079,223,SDTMIG v3.3,FA,,,,,,,,,,text,,
COLSTYP,SUPPFA.QVAL,Collected Summarized Value Type Response,C177908,224,TAUG-T1D-ENM v1.0; TAUG-T1D-PDM v1.0,FA,,,,,,,SUPPFA.QNAM EQ "COLSRT",SUPPFA.QLABEL EQ "Collected Summary Result Type",,text,,
SETTING,SUPPFA.QVAL,Environmental Setting,C127262,225,TAUG-T1D-ENM v1.0,FA,,,,,,,SUPPFA.QNAM EQ "SETTING",SUPPFA.QLABEL EQ "Environmental Setting",,text,,
NY,SUPPFA.QVAL,No Yes Response,C66742,226,TAUG-T1D-ENM v1.0,FA,,,,,,,SUPPFA.QNAM EQ "RECVFL",SUPPFA.QLABEL EQ "Record Validity Flag",,text,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,IE,,,,,IE,C61536,,,,,,
IECAT,IECAT,Category for Inclusion/Exclusion,C66797,2,SDTMIG v3.3,IE,,,,,,,,,,,,
NY,IEORRES,No Yes Response,C66742,3,SDTMIG v3.3,IE,,,,,N; Y,C49487; C49488,,,,,,
NY,IESTRESC,No Yes Response,C66742,4,SDTMIG v3.3,IE,,,,,N; Y,C49487; C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,5,SDTMIG v3.3,IE,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,IS,,,,,IS,C112320,,,,,,
NY,ISBLFL,No Yes Response,C66742,2,SDTMIG v3.3,IS,,,,,Y,C49488,,,,,,
METHOD,ISMETHOD,Method,C85492,3,SDTMIG v3.3,IS,,,,,,,,,,,,
UNIT,ISORRESU,Unit,C71620,4,SDTMIG v3.3,IS,,,,,,,,,,,,
SPECTYPE,ISSPEC,Specimen Type,C78734,5,SDTMIG v3.3,IS,,,,,,,,,,,,
ND,ISSTAT,Not Done,C66789,6,SDTMIG v3.3,IS,,,,,,,,,,,,
UNIT,ISSTRESU,Unit,C71620,7,SDTMIG v3.3,IS,,,,,,,,,,,,
ISTEST,ISTEST,Immunogenicity Specimen Assessments Test Name,C120526,8,SDTMIG v3.3,IS,,,,,,,,,,,,
ISTESTCD,ISTESTCD,Immunogenicity Specimen Assessments Test Code,C120525,9,SDTMIG v3.3,IS,,,,,,,,,,,,
NY,ISLOBXFL,No Yes Response,C66742,10,SDTMIG v3.3,IS,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,11,SDTMIG v3.3,IS,,,,,,,,,,,,
SPECCOND,ISSPCCND,Specimen Condition,C78733,12,SDTM v1.7,IS,,,,,,,,,,,,
NY,ISDRVFL,No Yes Response,C66742,13,SDTM v1.7,IS,,,,,Y,C49488,,,,,,
NY,ISACPTFL,No Yes Response,C66742,14,SDTM v1.7,IS,,,,,Y,C49488,,,,,,
LOC,ISLOC,Anatomical Location,C74456,15,SDTM v1.7,IS,,,,,,,,,,,,
DIR,ISDIR,Directionality,C99074,16,SDTM v1.7,IS,,,,,,,,,,,,
LAT,ISLAT,Laterality,C99073,17,SDTM v1.7,IS,,,,,,,,,,,,
PORTOT,ISPORTOT,Portion/Totality,C99075,18,SDTM v1.7,IS,,,,,,,,,,,,
NY,ISSPCUFL,No Yes Response,C66742,19,SDTM v1.7,IS,,,,,N,C49487,,,,,,
,ISLOINC,,,20,SDTM v1.7,IS,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
MICROORG,SUPPIS.QVAL,Microorganism,C85491,21,TAUG-HIV v1.0; TAUG-T1D-SSM v1.0; TAUG-T1D-PDM v2.0,IS,,,,,,,SUPPIS.QNAM EQ "BDAGNT",SUPPIS.QLABEL EQ "Binding Agent",,,,
ISBDAGT,SUPPIS.QVAL,Binding Agent for Immunogenicity Tests,C181169,22,TAUG-HIV v1.0; TAUG-T1D-SSM v1.0; TAUG-T1D-PDM v2.0,IS,,,,,,,SUPPIS.QNAM EQ "BDAGNT",SUPPIS.QLABEL EQ "Binding Agent",,,,
TSTOPOBJ,SUPPIS.QVAL,Test Operational Objective,C181170,23,TAUG-T1D-SSM v1.0; TAUG-T1D-PDM v2.0,IS,,,,,,,SUPPIS.QNAM EQ "TSTOPO",SUPPIS.QLABEL EQ "Test Operational Objective",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,LB,,,,,LB,C49592,,,,,,
NY,LBACPTFL,No Yes Response,C66742,2,SDTM v1.7,LB,,,,,Y,C49488,,,,,,
NY,LBBLFL,No Yes Response,C66742,3,SDTMIG v3.3,LB,,,,,Y,C49488,,,,,,
DIR,LBDIR,Directionality,C99074,4,SDTM v1.7,LB,,,,,,,,,,,,
NY,LBDRVFL,No Yes Response,C66742,5,SDTMIG v3.3,LB,,,,,Y,C49488,,,,,,
EVAL,LBEVAL,Evaluator,C78735,6,SDTM v1.7,LB,,,,,,,,,,,,
NY,LBFAST,No Yes Response,C66742,7,SDTMIG v3.3,LB,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
LAT,LBLAT,Laterality,C99073,8,SDTM v1.7,LB,,,,,,,,,,,,
LOC,LBLOC,Anatomical Location,C74456,9,SDTM v1.7,LB,,,,,,,,,,,,
,LBLOINC,,,10,SDTMIG v3.3,LB,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
METHOD,LBMETHOD,Method,C85492,11,SDTMIG v3.3,LB,,,,,,,,,,,,
NRIND,LBNRIND,Reference Range Indicator,C78736,12,SDTMIG v3.3,LB,,,,,,,,,,,,
UNIT,LBORRESU,Unit,C71620,13,SDTMIG v3.3,LB,,,,,,,,,,,,
PORTOT,LBPORTOT,Portion/Totality,C99075,14,SDTM v1.7,LB,,,,,,,,,,,,
SPECCOND,LBSPCCND,Specimen Condition,C78733,15,SDTMIG v3.3,LB,,,,,,,,,,,,
NY,LBSPCUFL,No Yes Response,C66742,16,SDTM v1.7,LB,,,,,N,C49487,,,,,,
SPECTYPE,LBSPEC,Specimen Type,C78734,17,SDTMIG v3.3,LB,,,,,,,,,,,,
ND,LBSTAT,Not Done,C66789,18,SDTMIG v3.3,LB,,,,,,,,,,,,
LBSTRESC,LBSTRESC,Laboratory Test Standard Character Result,C102580,19,SDTMIG v3.3,LB,,,,,,,,,,,,
UNIT,LBSTRESU,Unit,C71620,20,SDTMIG v3.3,LB,,,,,,,,,,,,
LBTEST,LBTEST,Laboratory Test Name,C67154,21,SDTMIG v3.3,LB,,,,,,,,,,,,
LBTESTCD,LBTESTCD,Laboratory Test Code,C65047,22,SDTMIG v3.3,LB,,,,,,,,,,,,
,LBTOX,,,23,SDTMIG v3.3,LB,CTCAE Term,"CTCAE can be used here but is not required by US FDA. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm",US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
,LBTOXGR,,,24,SDTMIG v3.3,LB,Grade,"CTCAE can be used here but is not required by US FDA. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm",US National Cancer Institute (NCI),Common Terminology Criteria for Adverse Events (CTCAE),,,,,,,,
TOXGRV3,LBTOXGR,Common Terminology Criteria for Adverse Events V3.0,C66784,25,SDTMIG v3.3,LB,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA.",,,,,,,,,,
TOXGRV4,LBTOXGR,Common Terminology Criteria for Adverse Events V4.0,C87162,26,SDTMIG v3.3,LB,,"This codelist was retired in 2015-09-25 (package 23). Usage is dependent upon which version of CT is used. If any later versions of CT are in use, CTCAE can be used here but is not required by FDA.",,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,27,SDTM v1.7,LB,,,,,,,,,,,,
NY,SUPPLB.QVAL,No Yes Response,C66742,28,SDTMIG v3.3,LB,,,,,N; Y,C49487; C49488,SUPPLB.QNAM EQ "LBCLSIG",SUPPLB.QLABEL EQ "Clinically Significant",,,,
LBANMET,LBANMETH,Laboratory Analytical Method Calculation Formula,C160922,29,SDTM v1.7,LB,,,,,,,,,,,,
COLSTYP,SUPPLB.QVAL,Collected Summarized Value Type Response,C177908,30,TAUG-HIV v1.0; TAUG-T1D-PDM v2.0,LB,,,,,,,SUPPLB.QNAM EQ "COLSRT",SUPPLB.QLABEL EQ "Collected Summary Result Type",,,,
EPOCH,EPOCH,Epoch,C99079,31,SDTMIG v3.3,LB,,,,,,,,,,,,
NY,LBLOBXFL,No Yes Response,C66742,32,SDTMIG v3.3,LB,,,,,Y,C49488,,,,,,
RSLSCLRS,SUPPLB.QVAL,Result Scale Response,C177910,33,TAUG-Crohn v1.0,LB,,,,,,,SUPPLB.QNAM EQ "RSLSCL",SUPPLB.QLABEL EQ "Result Scale",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,MB,,,,,MB,C49602,,,,,,
NY,MBBLFL,No Yes Response,C66742,2,SDTMIG v3.3,MB,,,,,Y,C49488,,,,,,
NY,MBDRVFL,No Yes Response,C66742,3,SDTMIG v3.3,MB,,,,,Y,C49488,,,,,,
LOC,MBLOC,Anatomical Location,C74456,4,SDTMIG v3.3,MB,,,,,,,,,,,,
METHOD,MBMETHOD,Method,C85492,5,SDTMIG v3.3,MB,,,,,,,,,,,,
UNIT,MBORRESU,Unit,C71620,6,SDTMIG v3.3,MB,,,,,,,,,,,,
SPECCOND,MBSPCCND,Specimen Condition,C78733,7,SDTMIG v3.3,MB,,,,,,,,,,,,
SPECTYPE,MBSPEC,Specimen Type,C78734,8,SDTMIG v3.3,MB,,,,,,,,,,,,
ND,MBSTAT,Not Done,C66789,9,SDTMIG v3.3,MB,,,,,,,,,,,,
MICROORG,MBSTRESC,Microorganism,C85491,10,SDTMIG v3.3,MB,,,,,,,,,,,,
UNIT,MBSTRESU,Unit,C71620,11,SDTMIG v3.3,MB,,,,,,,,,,,,
MBTEST,MBTEST,Microbiology Test Name,C120528,12,SDTMIG v3.3,MB,,,,,,,,,,,,
MBTESTCD,MBTESTCD,Microbiology Test Code,C120527,13,SDTMIG v3.3,MB,,,,,,,,,,,,
,MBLOINC,,,14,SDTMIG v3.3,MB,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
NY,MBLOBXFL,No Yes Response,C66742,15,SDTMIG v3.3,MB,,,,,Y,C49488,,,,,,
NY,MBFAST,No Yes Response,C66742,16,SDTMIG v3.3,MB,,,,,Y,C49488,,,,,,
NY,MBACPTFL,No Yes Response,C66742,17,SDTM v1.7,MB,,,,,Y,C49488,,,,,,
DIR,MBDIR,Directionality,C99074,18,SDTMIG v3.3,MB,,,,,,,,,,,,
EVAL,MBEVAL,Evaluator,C78735,19,SDTM v1.7,MB,,,,,,,,,,,,
LAT,MBLAT,Laterality,C99073,20,SDTMIG v3.3,MB,,,,,,,,,,,,
NRIND,MBNRIND,Reference Range Indicator,C78736,21,SDTM v1.7,MB,,,,,,,,,,,,
PORTOT,MBPORTOT,Portion/Totality,C99075,22,SDTM v1.7,MB,,,,,,,,,,,,
NY,MBSPCUFL,No Yes Response,C66742,23,SDTM v1.7,MB,,,,,N,C49487,,,,,,
EPOCH,EPOCH,Epoch,C99079,24,SDTMIG v3.3,MB,,,,,,,,,,,,
MBFTSDTL,MBTSTDTL,Microbiology Findings Test Details,C174225,25,SDTMIG v3.3; TAUG-LuCa v1.0,MB,,"The codelist MBFTSDTL (C174225) was created to be used with SDTMIG v3.3 after IG publication, therefore the codelist does not appear in the domain specification table.",,,,,,,,,,
MCIDCERT,SUPPMB.QVAL,Microbial Identification Certainty,C102581,26,TAUG-TB v2.0,MB,,,,,,,SUPPMB.QNAM EQ "MCIDCERT",SUPPMB.QLABEL EQ "Microbial Identification Certainty",,,,
NY,SUPPMB.QVAL,No Yes Response,C66742,27,TAUG-TB v2.0,MB,,,,,Y,C49488,SUPPMB.QNAM EQ "CNTMIND",SUPPMB.QLABEL EQ "Culture Contamination Indicator",,,,
,SUPPMB.QVAL,,,28,TAUG-TB v2.0,MB,,Refer to Appendices E1 and E2 of the TAUG TB v2.0 for a list of smear scales and mappings for standardizing results.,,,,,SUPPMB.QNAM EQ "AFBSCAL",SUPPMB.QLABEL EQ "AFB Quantification Scale",,,,
,SUPPMB.QVAL,,,29,TAUG-TB v2.0,MB,,Refer to Appendices E3 and E4 of the TAUG TB v2.0 for a list of solid culture colony counts and mappings for standardizing results.,,,,,SUPPMB.QNAM EQ "COLSCAL",SUPPMB.QLABEL EQ "Colony Quantification Scale",,,,
CLTMDTYP,SUPPMB.QVAL,Culture Medium Type,C127264,30,SDTMIG v3.3,MB,,Recommendation to align with the NSV registry naming convention of QNAM="CLTMDM" and QLABEL="Culture Medium". NSV Registry Location: Non-standard Variable Registry Home,,,,,SUPPMB.QNAM EQ "MEDTYPE",SUPPMB.QLABEL EQ "Culture Medium Type",,,,
CLTMDTYP,SUPPMB.QVAL,Culture Medium Type,C127264,31,TAUG-TB v2.0,MB,,Recommendation to align with the NSV registry naming convention of QNAM="CLTMDM" and QLABEL="Culture Medium". NSV Registry Location: Non-standard Variable Registry Home,,,,,SUPPMB.QNAM EQ "MEDTYPE",SUPPMB.QLABEL EQ "Medium Type",,,,
CLTMDTYP,SUPPMB.QVAL,Culture Medium Type,C127264,32,TAUG-CDAD v1.0,MB,,Recommendation to align with the NSV registry naming convention of QNAM="CLTMDM" and QLABEL="Culture Medium". NSV Registry Location: Non-standard Variable Registry Home,,,,,SUPPMB.QNAM EQ "CLTMDM",SUPPMB.QLABEL EQ "Culture Medium",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,MI,,,,,MI,C95095,,,,,,
MITSCD,MITESTCD,SDTM Microscopic Findings Test Code,C132263,2,SDTMIG v3.3,MI,,,,,,,,,,,,
MITS,MITEST,SDTM Microscopic Findings Test Name,C132262,3,SDTMIG v3.3,MI,,,,,,,,,,,,
MIFTSDTL,MITSTDTL,Microscopic Findings Test Details,C125922,4,SDTMIG v3.3,MI,,,,,,,,,,,,
UNIT,MIORRESU,Unit,C71620,5,SDTMIG v3.3,MI,,,,,,,,,,,,
UNIT,MISTRESU,Unit,C71620,6,SDTMIG v3.3,MI,,,,,,,,,,,,
ND,MISTAT,Not Done,C66789,7,SDTMIG v3.3,MI,,,,,,,,,,,,
SPECTYPE,MISPEC,Specimen Type,C78734,8,SDTMIG v3.3,MI,,,,,,,,,,,,
SPECCOND,MISPCCND,Specimen Condition,C78733,9,SDTMIG v3.3,MI,,,,,,,,,,,,
LOC,MILOC,Anatomical Location,C74456,10,SDTMIG v3.3,MI,,,,,,,,,,,,
LAT,MILAT,Laterality,C99073,11,SDTMIG v3.3,MI,,,,,,,,,,,,
DIR,MIDIR,Directionality,C99074,12,SDTMIG v3.3,MI,,,,,,,,,,,,
NY,MIBLFL,No Yes Response,C66742,13,SDTMIG v3.3,MI,,,,,Y,C49488,,,,,,
NY,MIDRVFL,No Yes Response,C66742,14,SDTM v1.7,MI,,,,,Y,C49488,,,,,,
METHOD,MIMETHOD,Method,C85492,15,SDTMIG v3.3,MI,,,,,,,,,,,,
EVAL,MIEVAL,Evaluator,C78735,16,SDTMIG v3.3,MI,,,,,,,,,,,,
MEDEVAL,MIEVALID,Medical Evaluator,C96777,17,SDTM v1.7,MI,,,,,,,,,,,,
NY,MIACPTFL,No Yes Response,C66742,18,SDTM v1.7,MI,,,,,Y,C49488,,,,,,
NY,MISPCUFL,No Yes Response,C66742,19,SDTM v1.7,MI,,,,,N,C49487,,,,,,
EPOCH,EPOCH,Epoch,C99079,20,SDTMIG v3.3,MI,,,,,,,,,,,,
,MILOINC,,,21,SDTM v1.7,MI,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
CLMETH,SUPPMI.QVAL,Specimen Collection Method,C132314,22,TAUG-TB v2.0,MI,,,,,,,SUPPMI.QNAM EQ "CLMTH",SUPPMI.QLABEL EQ "Specimen Collection Method",,,,
NY,SUPPMI.QVAL,No Yes Response,C66742,23,TAUG-DMD v1.0,MI,,"NY codelist was not associated to MSKIND in TAUG-DMD v1.0. However, logically this codelist would apply.",,,,,SUPPMI.QNAM EQ "MSKIND",SUPPMI.QLABEL EQ "Masked Indicator",,,,
NY,MILOBXFL,No Yes Response,C66742,24,SDTMIG v3.3,MI,,,,,Y,C49488,,,,,,
,MICHRON,,,25,SDTM v1.7,MI,,CHRNCTY (C120529) is a codelist in the SEND CT. There is no restriction for SDTMIG implementation to use a codelist in the SEND CT.,,,,,,,,,,
,MIDISTR,,,26,SDTM v1.7,MI,,DSTRBN (C120530) is a codelist in the SEND CT. There is no restriction for SDTMIG implementation to use a codelist in the SEND CT.,,,,,,,,,,
TSTOPOBJ,SUPPMI.QVAL,Test Operational Objective,C181170,27,TAUG-Crohn v1.0,MI,,,,,,,SUPPMI.QNAM EQ "TSTOPO",SUPPMI.QLABEL EQ "Test Operational Objective",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,MK,,,,,MK,C102674,,,,,,
NY,MKACPTFL,No Yes Response,C66742,2,SDTM v1.7,MK,,,,,N; Y,C49487; C49488,,,,,,
NY,MKBLFL,No Yes Response,C66742,3,SDTMIG v3.3,MK,,,,,Y,C49488,,,,,,
DIR,MKDIR,Directionality,C99074,4,SDTMIG v3.3,MK,,,,,,,,,,,,
NY,MKDRVFL,No Yes Response,C66742,5,SDTMIG v3.3,MK,,,,,Y,C49488,,,,,,
EVAL,MKEVAL,Evaluator,C78735,6,SDTMIG v3.3,MK,,,,,,,,,,,,
MEDEVAL,MKEVALID,Medical Evaluator,C96777,7,SDTMIG v3.3,MK,,,,,,,,,,,,
LAT,MKLAT,Laterality,C99073,8,SDTMIG v3.3,MK,,,,,,,,,,,,
LOC,MKLOC,Anatomical Location,C74456,9,SDTMIG v3.3,MK,,,,,,,,,,,,
,MKLOINC,,,10,SDTM v1.7,MK,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
METHOD,MKMETHOD,Method,C85492,11,SDTMIG v3.3,MK,,,,,,,,,,,,
NRIND,MKNRIND,Reference Range Indicator,C78736,12,SDTM v1.7,MK,,,,,,,,,,,,
UNIT,MKORRESU,Unit,C71620,13,SDTMIG v3.3,MK,,,,,,,,,,,,
PORTOT,MKPORTOT,Portion/Totality,C99075,14,SDTM v1.7,MK,,,,,,,,,,,,
ND,MKSTAT,Not Done,C66789,15,SDTMIG v3.3,MK,,,,,,,,,,,,
UNIT,MKSTRESU,Unit,C71620,16,SDTMIG v3.3,MK,,,,,,,,,,,,
MUSCTS,MKTEST,Musculoskeletal System Finding Test Name,C127270,17,SDTMIG v3.3,MK,,,,,,,,,,,,
MUSCTSCD,MKTESTCD,Musculoskeletal System Finding Test Code,C127269,18,SDTMIG v3.3,MK,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,19,SDTMIG v3.3,MK,,,,,,,,,,,,
POSITION,MKPOS,Position,C71148,20,SDTMIG v3.3,MK,,,,,,,,,,,,
NY,MKLOBXFL,No Yes Response,C66742,21,SDTMIG v3.3,MK,,,,,Y,C49488,,,,,,
SEVRS,MKSEV,Severity Response,C165643,22,SDTM v1.7,MK,,,,,,,,,,,,
NY,SUPPMK.QVAL,No Yes Response,C66742,23,TAUG-T1D-ENM v1.0,MK,,,,,N; Y,C49487; C49488,SUPPMK.QNAM EQ "AFIJDS",SUPPMK.QLABEL EQ "Result Affected by Injury/Disability",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,MO,,,,,MO,C102671,,,,,,
MOTESTCD,MOTESTCD,Morphology Test Code,C114117,2,SDTMIG v3.3,MO,,This codelist was deprecated as of version 2016-09-30 of CDISC CT. The codelist is not referenced in the domain specification table of SDTMIGv3.3.,,,,,,,,,,
MOTEST,MOTEST,Morphology Test Name,C114116,3,SDTMIG v3.3,MO,,This codelist was deprecated as of version 2016-09-30 of CDISC CT. The codelist is not referenced in the domain specification table of SDTMIGv3.3.,,,,,,,,,,
POSITION,MOPOS,Position,C71148,4,SDTMIG v3.3,MO,,,,,,,,,,,,
UNIT,MOORRESU,Unit,C71620,5,SDTMIG v3.3,MO,,,,,,,,,,,,
UNIT,MOSTRESU,Unit,C71620,6,SDTMIG v3.3,MO,,,,,,,,,,,,
ND,MOSTAT,Not Done,C66789,7,SDTMIG v3.3,MO,,,,,,,,,,,,
SPECTYPE,MOSPEC,Specimen Type,C78734,8,SDTM v1.7,MO,,,,,,,,,,,,
SPECCOND,MOSPCCND,Specimen Condition,C78733,9,SDTM v1.7,MO,,,,,,,,,,,,
LOC,MOLOC,Anatomical Location,C74456,10,SDTMIG v3.3,MO,,,,,,,,,,,,
LAT,MOLAT,Laterality,C99073,11,SDTMIG v3.3,MO,,,,,,,,,,,,
DIR,MODIR,Directionality,C99074,12,SDTMIG v3.3,MO,,,,,,,,,,,,
PORTOT,MOPORTOT,Portion/Totality,C99075,13,SDTMIG v3.3,MO,,,,,,,,,,,,
NY,MOBLFL,No Yes Response,C66742,14,SDTMIG v3.3,MO,,,,,Y,C49488,,,,,,
NY,MODRVFL,No Yes Response,C66742,15,SDTMIG v3.3,MO,,,,,Y,C49488,,,,,,
METHOD,MOMETHOD,Method,C85492,16,SDTMIG v3.3,MO,,,,,,,,,,,,
EVAL,MOEVAL,Evaluator,C78735,17,SDTMIG v3.3,MO,,,,,,,,,,,,
MEDEVAL,MOEVALID,Medical Evaluator,C96777,18,SDTM v1.7,MO,,,,,,,,,,,,
NY,MOACPTFL,No Yes Response,C66742,19,SDTM v1.7,MO,,,,,Y,C49488,,,,,,
NY,MOSPCUFL,No Yes Response,C66742,20,SDTM v1.7,MO,,,,,N,C49487,,,,,,
EPOCH,EPOCH,Epoch,C99079,21,SDTMIG v3.3,MO,,,,,,,,,,,,
NY,MOLOBXFL,No Yes Response,C66742,22,SDTMIG v3.3,MO,,,,,Y,C49488,,,,,,
,MOLOINC,,,23,SDTM v1.7,MO,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
SEVRS,MOSEV,Severity Response,C165643,24,SDTM v1.7,MO,,,,,,,,,,,,
STENRF,MOENRF,Relation to Reference Period,C66728,25,SDTM v1.7,MO,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MOSTRF,Relation to Reference Period,C66728,26,SDTM v1.7,MO,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MOENRTPT,Relation to Reference Period,C66728,27,SDTM v1.7,MO,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
STENRF,MOSTRTPT,Relation to Reference Period,C66728,28,SDTM v1.7,MO,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,MS,,,,,MS,C61531,,,,,,
NY,MSBLFL,No Yes Response,C66742,2,SDTMIG v3.3,MS,,,,,Y,C49488,,,,,,
NY,MSDRVFL,No Yes Response,C66742,3,SDTMIG v3.3,MS,,,,,Y,C49488,,,,,,
METHOD,MSMETHOD,Method,C85492,4,SDTMIG v3.3,MS,,,,,,,,,,,,
UNIT,MSORRESU,Unit,C71620,5,SDTMIG v3.3,MS,,,,,,,,,,,,
MSRESCAT,MSRESCAT,Microbiology Susceptibility Testing Result Category,C85495,6,SDTMIG v3.3,MS,,"From SDTMIGv3.3, MS Domain Specification Table, CDISC Notes column: \n ""results from some susceptibility tests may report only a categorical result and not a numeric result. Thus, in order for susceptibility results to be represented consistently, MSRESCAT should no longer be used for this purpose. In this version, the core designation has been changed from Expected to Permissible.""",,,,,,,,,,
ND,MSSTAT,Not Done,C66789,7,SDTMIG v3.3,MS,,,,,,,,,,,,
UNIT,MSSTRESU,Unit,C71620,8,SDTMIG v3.3,MS,,,,,,,,,,,,
MSTEST,MSTEST,Microbiology Susceptibility Test Name,C128687,9,SDTMIG v3.3,MS,,,,,,,,,,,,
MSTESTCD,MSTESTCD,Microbiology Susceptibility Test Code,C128688,10,SDTMIG v3.3,MS,,,,,,,,,,,,
,MSLOINC,,,11,SDTMIG v3.3,MS,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
NY,MSACPTFL,No Yes Response,C66742,12,SDTMIG v3.3,MS,,,,,Y,C49488,,,,,,
DIR,MSDIR,Directionality,C99074,13,SDTMIG v3.3,MS,,,,,,,,,,,,
EVAL,MSEVAL,Evaluator,C78735,14,SDTMIG v3.3,MS,,,,,,,,,,,,
MEDEVAL,MSEVALID,Medical Evaluator,C96777,15,SDTMIG v3.3,MS,,,,,,,,,,,,
LAT,MSLAT,Laterality,C99073,16,SDTMIG v3.3,MS,,,,,,,,,,,,
NRIND,MSNRIND,Reference Range Indicator,C78736,17,SDTM v1.7,MS,,,,,,,,,,,,
PORTOT,MSPORTOT,Portion/Totality,C99075,18,SDTM v1.7,MS,,,,,,,,,,,,
NY,MSSPCUFL,No Yes Response,C66742,19,SDTMIG v3.3,MS,,,,,N,C49487,,,,,,
LOC,MSLOC,Anatomical Location,C74456,20,SDTMIG v3.3,MS,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,21,SDTMIG v3.3,MS,,,,,,,,,,,,
SPECTYPE,MSSPEC,Specimen Type,C78734,22,SDTMIG v3.3,MS,,,,,,,,,,,,
SPECCOND,MSSPCCND,Specimen Condition,C78733,23,SDTMIG v3.3,MS,,,,,,,,,,,,
NY,MSFAST,No Yes Response,C66742,24,SDTMIG v3.3,MS,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
NY,MSLOBXFL,No Yes Response,C66742,25,SDTMIG v3.3,MS,,,,,Y,C49488,,,,,,
UNIT,MSCONCU,Unit,C71620,26,SDTMIG v3.3; TAUG-TB v2.0,MS,,,,,,,,,,,,
STENRF,MSENRF,Relation to Reference Period,C66728,27,SDTMIG v3.3,MS,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MSENRTPT,Relation to Reference Period,C66728,28,SDTMIG v3.3,MS,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
STENRF,MSSTRTPT,Relation to Reference Period,C66728,29,SDTMIG v3.3,MS,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,MSSTRF,Relation to Reference Period,C66728,30,SDTMIG v3.3,MS,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
CLTMDTYP,SUPPMS.QVAL,Culture Medium Type,C127264,31,TAUG-TB v2.0,MS,,,,,,,SUPPMS.QNAM EQ "MEDTYPE",SUPPMS.QLABEL EQ "Medium Type",,,,
NY,SUPPMS.QVAL,No Yes Response,C66742,32,TAUG-Influenza v1.1; TAUG-Virology v2.1,MS,,,,,Y,C49488,SUPPMS.QNAM EQ "VDBLFL",SUPPMS.QLABEL EQ "Vendor-defined Baseline Flag",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,NV,,,,,NV,C102677,,,,,,
NVTESTCD,NVTESTCD,Nervous System Findings Test Code,C116104,2,SDTMIG v3.3,NV,,,,,,,,,,,,
NVTEST,NVTEST,Nervous System Findings Test Name,C116103,3,SDTMIG v3.3,NV,,,,,,,,,,,,
UNIT,NVORRESU,Unit,C71620,4,SDTMIG v3.3,NV,,,,,,,,,,,,
UNIT,NVSTRESU,Unit,C71620,5,SDTMIG v3.3,NV,,,,,,,,,,,,
ND,NVSTAT,Not Done,C66789,6,SDTMIG v3.3,NV,,,,,,,,,,,,
LOC,NVLOC,Anatomical Location,C74456,7,SDTMIG v3.3,NV,,,,,,,,,,,,
LAT,NVLAT,Laterality,C99073,8,SDTMIG v3.3,NV,,,,,,,,,,,,
DIR,NVDIR,Directionality,C99074,9,SDTMIG v3.3,NV,,,,,,,,,,,,
METHOD,NVMETHOD,Method,C85492,10,SDTMIG v3.3,NV,,,,,,,,,,,,
NY,NVLOBXFL,No Yes Response,C66742,11,SDTMIG v3.3,NV,,,,,Y,C49488,,,,,,
NY,NVBLFL,No Yes Response,C66742,12,SDTMIG v3.3,NV,,,,,Y,C49488,,,,,,
NY,NVDRVFL,No Yes Response,C66742,13,SDTMIG v3.3,NV,,,,,Y,C49488,,,,,,
EVAL,NVEVAL,Evaluator,C78735,14,SDTMIG v3.3,NV,,,,,,,,,,,,
MEDEVAL,NVEVALID,Medical Evaluator,C96777,15,SDTMIG v3.3,NV,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,16,SDTMIG v3.3,NV,,,,,,,,,,,,
NY,NVACPTFL,No Yes Response,C66742,17,SDTM v1.7,NV,,,,,N; Y,C49487; C49488,,,,,,
POSITION,NVPOS,Position,C71148,18,SDTM v1.7,NV,,,,,,,,,,,,
PORTOT,NVPORTOT,Portion/Totality,C99075,19,SDTM v1.7,NV,,,,,,,,,,,,
,NVLOINC,,,20,SDTM v1.7,NV,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
CSTATE,NVCSTATE,Consciousness State,C90018,21,SDTM v1.7,NV,,,,,,,,,,,,
SEVRS,NVSEV,Severity Response,C165643,22,SDTM v1.7,NV,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,OE,,,,,OE,C147180,,,,,,
OEFOCUS,FOCID,Ophthalmic Focus of Study Specific Interest,C119013,2,SDTMIG v3.3,OE,,,,,,,,,,,,
OETESTCD,OETESTCD,Ophthalmic Exam Test Code,C117743,3,SDTMIG v3.3,OE,,,,,,,,,,,,
OETEST,OETEST,Ophthalmic Exam Test Name,C117742,4,SDTMIG v3.3,OE,,,,,,,,,,,,
UNIT,OEORRESU,Unit,C71620,5,SDTMIG v3.3,OE,,,,,,,,,,,,
UNIT,OESTRESU,Unit,C71620,6,SDTMIG v3.3,OE,,,,,,,,,,,,
NRIND,OENRIND,Reference Range Indicator,C78736,7,SDTMIG v3.3,OE,,,,,,,,,,,,
ND,OESTAT,Not Done,C66789,8,SDTMIG v3.3,OE,,,,,,,,,,,,
LOC,OELOC,Anatomical Location,C74456,9,SDTMIG v3.3,OE,,,,,,,,,,,,
LAT,OELAT,Laterality,C99073,10,SDTMIG v3.3,OE,,,,,,,,,,,,
DIR,OEDIR,Directionality,C99074,11,SDTMIG v3.3,OE,,,,,,,,,,,,
PORTOT,OEPORTOT,Portion/Totality,C99075,12,SDTMIG v3.3,OE,,,,,,,,,,,,
METHOD,OEMETHOD,Method,C85492,13,SDTMIG v3.3,OE,,,,,,,,,,,,
NY,OELOBXFL,No Yes Response,C66742,14,SDTMIG v3.3,OE,,,,,Y,C49488,,,,,,
NY,OEBLFL,No Yes Response,C66742,15,SDTMIG v3.3,OE,,,,,Y,C49488,,,,,,
NY,OEDRVFL,No Yes Response,C66742,16,SDTMIG v3.3,OE,,,,,Y,C49488,,,,,,
EVAL,OEEVAL,Evaluator,C78735,17,SDTMIG v3.3,OE,,,,,,,,,,,,
MEDEVAL,OEEVALID,Medical Evaluator,C96777,18,SDTMIG v3.3,OE,,,,,,,,,,,,
NY,OEACPTFL,No Yes Response,C66742,19,SDTMIG v3.3,OE,,,,,N; Y,C49487; C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,20,SDTMIG v3.3,OE,,,,,,,,,,,,
,OELOINC,,,21,SDTM v1.7,OE,LOINC Code,,Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
SEVRS,OESEV,Severity Response,C165643,22,SDTM v1.7,OE,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,PC,,,,,PC,C49606,,,,,,
PKUNIT,PCORRESU,PK Units of Measure,C85494,2,SDTMIG v3.3,PC,,,,,,,,,,,,
PKUNIT,PCSTRESU,PK Units of Measure,C85494,3,SDTMIG v3.3,PC,,,,,,,,,,,,
ND,PCSTAT,Not Done,C66789,4,SDTMIG v3.3,PC,,,,,,,,,,,,
SPECTYPE,PCSPEC,Specimen Type,C78734,5,SDTMIG v3.3,PC,,,,,,,,,,,,
SPECCOND,PCSPCCND,Specimen Condition,C78733,6,SDTMIG v3.3,PC,,,,,,,,,,,,
NY,PCSPCUFL,No Yes Response,C66742,7,SDTM v1.7,PC,,,,,N,C49487,,,,,,
METHOD,PCMETHOD,Method,C85492,8,SDTMIG v3.3,PC,,,,,,,,,,,,
NY,PCFAST,No Yes Response,C66742,9,SDTMIG v3.3,PC,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
NY,PCDRVFL,No Yes Response,C66742,10,SDTMIG v3.3,PC,,,,,Y,C49488,,,,,,
NY,PCBLFL,No Yes Response,C66742,11,SDTM v1.7,PC,,,,,Y,C49488,,,,,,
,PCLOINC,,,12,SDTM v1.7,PC,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
EPOCH,EPOCH,Epoch,C99079,13,SDTMIG v3.3,PC,,,,,,,,,,,,
NY,PCLOBXFL,No Yes Response,C66742,14,SDTM v1.7,PC,,,,,Y,C49488,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,PE,,,,,PE,C49608,,,,,,
POSITION,PEPOS,Position,C71148,2,SDTM v1.7,PE,,,,,,,,,,,,
,PEBODSYS,,,3,SDTMIG v3.3,PE,System Organ Class,"Many people use MedDRA, but some older data may use other coding dictionaries like COSTART, etc. There is no regulatory mandate for a specific terminology to be used for PEBODSYS. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.meddra.org/",Maintenance and Support Services Organization (MSSO),Medical Dictionary for Regulatory Activities (MedDRA),,,,,,,,
UNIT,PEORRESU,Unit,C71620,4,SDTMIG v3.3,PE,,,,,,,,,,,,
ND,PESTAT,Not Done,C66789,5,SDTMIG v3.3,PE,,,,,,,,,,,,
,PELOINC,,,6,SDTM v1.7,PE,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
LOC,PELOC,Anatomical Location,C74456,7,SDTMIG v3.3,PE,,,,,,,,,,,,
LAT,PELAT,Laterality,C99073,8,SDTMIG v3.3,PE,,,,,,,,,,,,
DIR,PEDIR,Directionality,C99074,9,SDTM v1.7,PE,,,,,,,,,,,,
PORTOT,PEPORTOT,Portion/Totality,C99075,10,SDTM v1.7,PE,,,,,,,,,,,,
METHOD,PEMETHOD,Method,C85492,11,SDTMIG v3.3,PE,,,,,,,,,,,,
NY,PELOBXFL,No Yes Response,C66742,12,SDTMIG v3.3,PE,,,,,Y,C49488,,,,,,
NY,PEBLFL,No Yes Response,C66742,13,SDTMIG v3.3,PE,,,,,Y,C49488,,,,,,
NY,PEDRVFL,No Yes Response,C66742,14,SDTM v1.7,PE,,,,,Y,C49488,,,,,,
EVAL,PEEVAL,Evaluator,C78735,15,SDTMIG v3.3,PE,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,16,SDTMIG v3.3,PE,,,,,,,,,,,,
NY,SUPPPE.QVAL,No Yes Response,C66742,17,SDTMIG v3.3,PE,,,,,N; Y,C49487; C49488,SUPPPE.QNAM EQ "PECLSIG",SUPPPE.QLABEL EQ "Clinically Significant",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,PP,,,,,PP,C49607,,,,,,
PKPARMCD,PPTESTCD,PK Parameters Code,C85839,2,SDTMIG v3.3,PP,,,,,,,,,,,,
PKPARM,PPTEST,PK Parameters,C85493,3,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUNIT,PPORRESU,PK Units of Measure,C85494,4,SDTMIG v3.3,PP,,3.3 Assumptions: \n Codelist "PKUNIT" is used for non-normalized parameters. Codelists "PKUDMG" and "PKUDUG" are used when parameters are normalized by dose amount in milligrams or micrograms respectively. Codelists "PKUWG" and "PKUWKG" are used when parameters are normalized by weight in grams or kilograms respectively.,,,,,,,,,,
PKUWG,PPORRESU,PK Units of Measure - Weight g,C128684,5,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUWKG,PPORRESU,PK Units of Measure - Weight kg,C128683,6,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUDMG,PPORRESU,PK Units of Measure - Dose mg,C128685,7,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUDUG,PPORRESU,PK Units of Measure - Dose ug,C128686,8,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUNIT,PPSTRESU,PK Units of Measure,C85494,9,SDTMIG v3.3,PP,,"Any of these can be used PKUNIT, PKUDMG, PKUDUG, PKUWG, PKUWKG. Usage of PKUDMG, PKUDUG, PKUWG, PKUWKG is dependent of the test.",,,,,,,,,,
PKUWG,PPSTRESU,PK Units of Measure - Weight g,C128684,10,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUWKG,PPSTRESU,PK Units of Measure - Weight kg,C128683,11,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUDMG,PPSTRESU,PK Units of Measure - Dose mg,C128685,12,SDTMIG v3.3,PP,,,,,,,,,,,,
PKUDUG,PPSTRESU,PK Units of Measure - Dose ug,C128686,13,SDTMIG v3.3,PP,,,,,,,,,,,,
ND,PPSTAT,Not Done,C66789,14,SDTMIG v3.3,PP,,,,,,,,,,,,
SPECTYPE,PPSPEC,Specimen Type,C78734,15,SDTMIG v3.3,PP,,,,,,,,,,,,
PKANMET,PPANMETH,PK Analytical Method,C172330,16,SDTM v1.7,PP,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,17,SDTMIG v3.3,PP,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,RE,,,,,RE,C95098,,,,,,
RETESTCD,RETESTCD,Respiratory Test Code,C111106,2,SDTMIG v3.3,RE,,,,,,,,,,,,
RETEST,RETEST,Respiratory Test Name,C111107,3,SDTMIG v3.3,RE,,,,,,,,,,,,
POSITION,REPOS,Position,C71148,4,SDTMIG v3.3,RE,,,,,,,,,,,,
UNIT,REORRESU,Unit,C71620,5,SDTMIG v3.3,RE,,,,,,,,,,,,
UNIT,RESTRESU,Unit,C71620,6,SDTMIG v3.3,RE,,,,,,,,,,,,
ND,RESTAT,Not Done,C66789,7,SDTMIG v3.3,RE,,,,,,,,,,,,
LOC,RELOC,Anatomical Location,C74456,8,SDTMIG v3.3,RE,,,,,,,,,,,,
LAT,RELAT,Laterality,C99073,9,SDTMIG v3.3,RE,,,,,,,,,,,,
DIR,REDIR,Directionality,C99074,10,SDTMIG v3.3,RE,,,,,,,,,,,,
METHOD,REMETHOD,Method,C85492,11,SDTMIG v3.3,RE,,,,,,,,,,,,
NY,RELOBXFL,No Yes Response,C66742,12,SDTMIG v3.3,RE,,,,,Y,C49488,,,,,,
NY,REBLFL,No Yes Response,C66742,13,SDTMIG v3.3,RE,,,,,Y,C49488,,,,,,
NY,REDRVFL,No Yes Response,C66742,14,SDTMIG v3.3,RE,,,,,Y,C49488,,,,,,
EVAL,REEVAL,Evaluator,C78735,15,SDTMIG v3.3,RE,,,,,,,,,,,,
MEDEVAL,REEVALID,Medical Evaluator,C96777,16,SDTMIG v3.3,RE,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,17,SDTMIG v3.3,RE,,,,,,,,,,,,
NY,REACPTFL,No Yes Response,C66742,18,SDTM v1.7,RE,,,,,N; Y,C49487; C49488,,,,,,
POSITION,REPOS,Position,C71148,19,SDTM v1.7,RE,,,,,,,,,,,,
PORTOT,REPORTOT,Portion/Totality,C99075,20,SDTM v1.7,RE,,,,,,,,,,,,
,RELOINC,,,21,SDTM v1.7,RE,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
CSTATE,RECSTATE,Consciousness State,C90018,22,SDTM v1.7,RE,,,,,,,,,,,,
SEVRS,RESEV,Severity Response,C165643,23,SDTM v1.7,RE,,,,,,,,,,,,
NY,SUPPRE.QVAL,No Yes Response,C66742,24,TAUG-COVID-19 v1.0,RE,,"As per SDTMIG v3.3, the QLABEL for this NSV is published as ""Clinically Significant"".",,,N; Y,C49487; C49488,SUPPRE.QNAM EQ "CLSIG","SUPPRE.QLABEL EQ ""Clinically Significant, Collected""",,,,
NY,SUPPRE.QVAL,No Yes Response,C66742,25,TAUG-T1D-ENM v1.0,RE,,,,,,,SUPPRE.QNAM EQ "SCMIND",SUPPRE.QLABEL EQ "Standardized Test Criteria Met Indicator",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,RP,,,,,RP,C102707,,,,,,
RPTESTCD,RPTESTCD,Reproductive System Findings Test Code,C106479,2,SDTMIG v3.3,RP,,,,,,,,,,,,
RPTEST,RPTEST,Reproductive System Findings Test Name,C106478,3,SDTMIG v3.3,RP,,,,,,,,,,,,
UNIT,RPORRESU,Unit,C71620,4,SDTMIG v3.3,RP,,,,,,,,,,,,
UNIT,RPSTRESU,Unit,C71620,5,SDTMIG v3.3,RP,,,,,,,,,,,,
ND,RPSTAT,Not Done,C66789,6,SDTMIG v3.3,RP,,,,,,,,,,,,
NY,RPBLFL,No Yes Response,C66742,7,SDTMIG v3.3,RP,,,,,Y,C49488,,,,,,
NY,RPDRVFL,No Yes Response,C66742,8,SDTMIG v3.3,RP,,,,,Y,C49488,,,,,,
NRIND,RPNRIND,Reference Range Indicator,C78736,9,SDTM v1.7,RP,,,,,,,,,,,,
,RPLOINC,,,10,SDTM v1.7,RP,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
LOC,RPLOC,Anatomical Location,C74456,11,SDTM v1.7,RP,,,,,,,,,,,,
LAT,RPLAT,Laterality,C99073,12,SDTM v1.7,RP,,,,,,,,,,,,
DIR,RPDIR,Directionality,C99074,13,SDTM v1.7,RP,,,,,,,,,,,,
PORTOT,RPPORTOT,Portion/Totality,C99075,14,SDTM v1.7,RP,,,,,,,,,,,,
METHOD,RPMETHOD,Method,C85492,15,SDTM v1.7,RP,,,,,,,,,,,,
EVAL,RPEVAL,Evaluator,C78735,16,SDTM v1.7,RP,,,,,,,,,,,,
MEDEVAL,RPEVALID,Medical Evaluator,C96777,17,SDTM v1.7,RP,,,,,,,,,,,,
NY,RPACPTFL,No Yes Response,C66742,18,SDTM v1.7,RP,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,19,SDTM v1.7,RP,,,,,,,,,,,,
NY,RPLOBXFL,No Yes Response,C66742,20,SDTMIG v3.3,RP,,,,,Y,C49488,,,,,,
SEVRS,RPSEV,Severity Response,C165643,21,SDTM v1.7,RP,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,RS,,,,,RS,C107097,,,,,,
ONCRTS,RSTEST,Oncology Response Assessment Test Name,C96781,2,SDTMIG v3.3,RS,,,,,,,,,,,,
ONCRTSCD,RSTESTCD,Oncology Response Assessment Test Code,C96782,3,SDTMIG v3.3,RS,,,,,,,,,,,,
ONCRSCAT,RSCAT,Category of Oncology Response Assessment,C124298,4,SDTMIG v3.3,RS,,Please refer to the Oncology Codetable Mapping file on CDISC.org for appropriate use of RSCAT values with associated TEST and TESTCD values.,,,,,,,,,,
ND,RSSTAT,Not Done,C66789,5,SDTMIG v3.3,RS,,,,,,,,,,,,
ONCRSR,RSSTRESC,Oncology Response Assessment Result,C96785,6,SDTMIG v3.3,RS,,,,,,,,,,,,
EVAL,RSEVAL,Evaluator,C78735,7,SDTMIG v3.3,RS,,,,,,,,,,,,
MEDEVAL,RSEVALID,Medical Evaluator,C96777,8,SDTMIG v3.3,RS,,,,,,,,,,,,
NY,RSACPTFL,No Yes Response,C66742,9,SDTMIG v3.3,RS,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,10,SDTMIG v3.3,RS,,,,,,,,,,,,
NY,RSBLFL,No Yes Response,C66742,11,SDTMIG v3.3,RS,,,,,Y,C49488,,,,,,
NY,RSDRVFL,No Yes Response,C66742,12,SDTMIG v3.3,RS,,,,,Y,C49488,,,,,,
NY,RSLOBXFL,No Yes Response,C66742,13,SDTMIG v3.3,RS,,,,,Y,C49488,,,,,,
UNIT,RSORRESU,Unit,C71620,14,SDTMIG v3.3,RS,,,,,,,,,,,,
UNIT,RSSTRESU,Unit,C71620,15,SDTMIG v3.3,RS,,,,,,,,,,,,
STENRF,RSENRTPT,Relation to Reference Period,C66728,16,SDTMIG v3.3,RS,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SC,,,,,SC,C49610,,,,text,,
SCTESTCD,SCTESTCD,Subject Characteristic Test Code,C74559,2,SDTMIG v3.3,SC,,,,,,,,,,text,,
SCTEST,SCTEST,Subject Characteristic Test Name,C103330,3,SDTMIG v3.3,SC,,,,,,,,,,text,,
UNIT,SCORRESU,Unit,C71620,4,SDTMIG v3.3,SC,,,,,,,,,,text,,
UNIT,SCSTRESU,Unit,C71620,5,SDTMIG v3.3,SC,,,,,,,,,,text,,
ND,SCSTAT,Not Done,C66789,6,SDTMIG v3.3,SC,,,,,,,,,,text,,
EVAL,SCEVAL,Evaluator,C78735,7,SDTM v1.7,SC,,,,,,,,,,text,,
EPOCH,EPOCH,Epoch,C99079,8,SDTM v1.7,SC,,,,,,,,,,text,,
,SCLOINC,,,9,SDTM v1.7,SC,LOINC Code,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,text,,
NY,SCSTRESC,No Yes Response,C66742,10,TAUG-TB v2.0,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "BRFEDIND",SCTEST EQ "Breast Fed Indicator",C112233,text,C112233,
,SCSTRESC,,,11,TAUG-EVD v1.0,SC,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,SCTESTCD EQ "CTRYDEXP",SCTEST EQ "Country of Potential Disease Exposure",C102612,text,C102612,
,SCSTRESC,,,12,TAUG-EVD v1.0,SC,ISO 3166-1 Alpha-3,"New term to be added to (SCTEST) and (SCTESTCD) \n Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,SCTESTCD EQ "CTRYPAD",SCTEST EQ "Country of Permanent Address",C176365,text,C176365,
,SCSTRESC,,,13,TAUG-EVD v1.0,SC,Uniform Resource Identifier for Geographic Locations ('geo' URI),"New term to be added to (SCTEST) and (SCTESTCD) \n Link to general information about the cited external dictionary, accessed 2023-02-10: https://tools.ietf.org/html/rfc5870/",Internet Engineering Task Force (IETF),Request for Comments 5870 (RFC 5870),,,SCTESTCD EQ "GPSDEXP",SCTEST EQ "GPS Coord of Potential Disease Exposure",C174365,text,C174365,
NY,SCSTRESC,No Yes Response,C66742,14,TAUG-KT v1.0,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "HIVHRIND",SCTEST EQ "CDC HIV High Risk Donor Indicator",C139271,text,C139271,
,SCSTRESC,,,15,TAUG-EVD v1.0,SC,ISO 639-3 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-639-language-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of languages - Part 3: Alpha-3 code for comprehensive coverage of languages (ISO 639-3),,,SCTESTCD EQ "LNGSPP",SCTEST EQ "Primary Language Spoken",C132459,text,C132459,
,SCSTRESC,,,16,TAUG-EVD v1.0,SC,ISO 639-3 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-639-language-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of languages - Part 3: Alpha-3 code for comprehensive coverage of languages (ISO 639-3),,,SCTESTCD EQ "LNGSPS",SCTEST EQ "Secondary Language Spoken",C132460,text,C132460,
NY,SCSTRESC,No Yes Response,C66742,17,SDTMIG v3.3,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "LVSBJIND",SCTEST EQ "Living with Subject Indicator",C135502,text,C135502,
,SCSTRESC,,,18,TAUG-TB v2.0,SC,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,SCTESTCD EQ "NATORIG",SCTEST EQ "National Origin",C28407,text,C28407,
NY,SCSTRESC,No Yes Response,C66742,19,SDTMIG v3.3; TAUG-HIV v1.0,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "SMGAIND",SCTEST EQ "Small for Gestational Age Indicator",C156662,text,C156662,
NY,SCSTRESC,No Yes Response,C66742,20,SDTMIG v3.3,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "STDNTIND",SCTEST EQ "Student Indicator",C147485,text,C147485,
MARISTAT,SCSTRESC,Marital Status Response,C76348,21,SDTMIG v3.2; TAUG-EVD v1.0,SC,,,,,,,SCTESTCD EQ "MARISTAT",SCTEST EQ "Marital Status",C25188,text,C25188,
SEX,SCSTRESC,Sex,C66731,22,TAUG-TB v2.0,SC,,,,,,,SCTESTCD EQ "SEXRBRTH",SCTEST EQ "Sex Reported at Birth",C124436,text,C124436,
SKINCLAS,SCSTRESC,Fitzpatrick Skin Classification Response,C76351,23,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "SKINCLAS",SCTEST EQ "Skin Classification",C74563,text,C74563,
LAT,SCSTRESC,Laterality,C99073,24,SDTMIG v3.3,SC,,,,,LEFT; RIGHT,C25229; C25228,SCTESTCD EQ "HANDDOM",SCTEST EQ "Dominant Hand",C114182,text,C114182,
NY,SCSTRESC,No Yes Response,C66742,25,TAUG-COVID-19 v1.0,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "ADEVAIND",SCTEST EQ "Appropriate Developmental Age Indicator",C171499,text,C171499,
,SCSTRESC,,,26,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "BIOBRON","SCTEST EQ ""Number of Brothers, Biological""",C135500,integer,C135500,
,SCSTRESC,,,27,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "BIOSISN","SCTEST EQ ""Number of Sisters, Biological""",C135501,integer,C135501,
NY,SCSTRESC,No Yes Response,C66742,28,TAUG-TB v1.0,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "CINVIND",SCTEST EQ "Contact Investigation Indicator",C102625,text,C202576,
,SCSTRESC,,,29,TAUG-EVD v1.0,SC,,,,,,,SCTESTCD EQ "CNTYPAD",SCTEST EQ "County of Permanent Address",C176362,text,C176362,
,SCSTRESC,,,30,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "CTRYDDTC",SCTEST EQ "Entry Date from Ptntl Cntry Disease Exp",C102631,datetime,C102631,
,SCSTRESC,,,31,TAUG-KT v1.0,SC,,,,,,,SCTESTCD EQ "DDDTYPE",SCTEST EQ "Deceased Donor Donation Type",C139270,text,C139270,
,SCSTRESC,,,32,TAUG-EVD v1.0,SC,,,,,,,SCTESTCD EQ "DISTDEXP",SCTEST EQ "District of Potential Disease Exposure",C174364,text,C174364,
,SCSTRESC,,,33,TAUG-EVD v1.0,SC,,,,,,,SCTESTCD EQ "DISTPAD",SCTEST EQ "District of Permanent Address",C176363,text,C176363,
,SCSTRESC,,,34,TAUG-KT v1.0,SC,,,,,,,SCTESTCD EQ "DSTATTOD",SCTEST EQ "Donor Status at Time of Organ Donation",C139269,text,C139269,
,SCSTRESC,,,35,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "EDULEVEL",SCTEST EQ "Level of Education Attained",C17953,text,C17953,
,SCSTRESC,,,36,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "EDUYRNUM",SCTEST EQ "Number of Years of Education",C122393,float,C122393,
,SCSTRESC,,,37,CDASH SAE,SC,,,,,,,SCTESTCD EQ "EGESTAGE",SCTEST EQ "Estimated Gestational Age",C122188,float,C122188,
,SCSTRESC,,,38,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "EMPJOB",SCTEST EQ "Employee Job",C25193,text,,
,SCSTRESC,,,39,TAUG-HIV v1.0,SC,,,,,,,SCTESTCD EQ "GENIDENT",SCTEST EQ "Gender Identity",C158277,text,C158277,
,SCSTRESC,,,40,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "GSTABRTH",SCTEST EQ "Gestational Age at Birth",C124435,float,C124435,
AGEU,SCSTRESU,Age Unit,C66781,41,SDTMIG v3.3,SC,,,,,WEEKS; DAYS,C29844; C25301,SCTESTCD EQ "GSTABRTH",SCTEST EQ "Gestational Age at Birth",C124435,text,C124435,
,SCSTRESC,,,42,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "INCMLVL",SCTEST EQ "Income Level",C154890,text,C154890,
NY,SCSTRESC,No Yes Response,C66742,43,TAUG-COVID-19 v1.0,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "INL1YIND",SCTEST EQ "Infant Less Than One Year Indicator",C171513,text,C171513,
EMPSTAT,SCSTRESC,Employment Status,C111108,44,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "JOBCLAS",SCTEST EQ "Employee Job Class",C74565,text,C74565,
,SCSTRESC,,,45,TAUG-T1D-ENM v1.0,SC,,,,,,,SCTESTCD EQ "PHYACLFS",SCTEST EQ "Physical Activity Lifestyle",C179818,text,C179818,
NY,SCSTRESC,No Yes Response,C66742,46,SDTMIG v3.3,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "PREMBRTH",SCTEST EQ "Premature Birth Indicator",C112400,text,C112400,
PRITBCON,SCSTRESC,Priority of Tuberculosis Contact,C102582,47,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "PRICON",SCTEST EQ "Priority of Disease Contact",C102699,text,C102699,
NY,SCSTRESC,No Yes Response,C66742,48,SDTMIG v3.3,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "RISKPOP",SCTEST EQ "Member of High Risk Population",C102666,text,C102666,
RISKSOC,SCSTRESC,Social Risk Factor,C102587,49,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "RISKSOC",SCTEST EQ "Social Risk Factor",C102711,text,C102711,
,SCSTRESC,,,50,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "SALTYP",SCTEST EQ "Employee Salary Type",C74566,text,C74566,
SETTING,SCSTRESC,Environmental Setting,C127262,51,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "SETCON",SCTEST EQ "Setting of Contact",C102708,text,C102708,
,SCSTRESC,,,52,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "SYMPTOM",SCTEST EQ "Symptom",C4876,text,C4876,
,SCSTRESC,,,53,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "TWINTYP",SCTEST EQ "Twin Type",C112424,text,C112424,
CCINVTYP,SCSTRESC,Contact Case Investigation Contact Type,C102575,54,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "TYPCON",SCTEST EQ "Type of Contact",C102723,text,C102723,
,SCSTRESC,,,55,TAUG-EVD v1.0,SC,,,,,,,SCTESTCD EQ "VILLPAD",SCTEST EQ "Village of Permanent Address",C176364,text,C176364,
,SCSTRESC,,,56,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "BIO1DRN","SCTEST EQ ""Num 1st Degree Relatives, Biological""",C198360,integer,C198360,
,SCSTRESC,,,57,SDTMIG v3.3,SC,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,SCTESTCD EQ "BRCTRY",SCTEST EQ "Birth Country",C200441,text,C200441,
,SCSTRESC,,,58,SDTMIG v3.3,SC,GENC Alpha 3,"Link to general information about the cited external dictionary, accessed 2024-04-19: Index of /ftp1/GENC (nih.gov)",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,SCTESTCD EQ "BRCTRY",SCTEST EQ "Birth Country",C200441,text,C200441,
,SCSTRESC,,,59,SDTMIG v3.3,SC,ISO 3166-1 numeric,"Link to general information about the cited external dictionary, accessed 2023-02-10: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,SCTESTCD EQ "BRCTRYCD",SCTEST EQ "Birth Country Code",C93516,text,C93516,
,SCSTRESC,,,60,SDTMIG v3.3,SC,GENC Number,"Link to general information about the cited external dictionary, accessed 2024-04-19: Index of /ftp1/GENC (nih.gov)",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,SCTESTCD EQ "BRCTRYCD",SCTEST EQ "Birth Country Code",C93516,text,C93516,
,SCSTRESC,,,61,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "BTHPLRTY",SCTEST EQ "Birth Plurality",C198361,text,C198361,
,SCSTRESC,,,62,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "CHLDHSHN",SCTEST EQ "Number of Children in Household",C19309,integer,C19309,
NY,SCSTRESC,No Yes Response,C66742,63,SDTMIG v3.3,SC,,,,,N; Y; U,C49487; C49488; C17998,SCTESTCD EQ "DAYCRIND",SCTEST EQ "Daycare Indicator",C198362,text,C198362,
,SCSTRESC,,,64,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "EDLVRDTC",SCTEST EQ "Estimated Date of Delivery",C81247,datetime,C81247,
,SCSTRESC,,,65,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "FRTLSTAT",SCTEST EQ "Fertility Status",C186214,text,C186214,
,SCSTRESC,,,66,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "MILTSTAT",SCTEST EQ "Military Status",C171085,text,C171085,
,SCSTRESC,,,67,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "PPLHSHN",SCTEST EQ "Number of People in Household",C198363,integer,C198363,
,SCSTRESC,,,68,SDTMIG v3.3,SC,,,,,,,SCTESTCD EQ "SOCECCLS",SCTEST EQ "Socioeconomic Classification",C198364,text,C198364,
NY,SCLOBXFL,No Yes Response,C66742,69,SDTM v1.7,SC,,,,,Y,C49488,,,,text,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SR,,,,,SR,C112420,,,,,,
SRTESTCD,SRTESTCD,Skin Response Test Code,C112024,2,SDTMIG v3.3,SR,,,,,,,,,,,,
SRTEST,SRTEST,Skin Response Test Name,C112023,3,SDTMIG v3.3,SR,,,,,,,,,,,,
,SRSTRESC,,,4,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "ASRINDEX",SRTEST EQ "Allergen Skin Response Index",C112221,float,C112221,
,SRSTRESC,,,5,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "ASRINT",SRTEST EQ "Allergen Skin Response Intensity",C112222,text,C112222,
NY,SRSTRESC,No Yes Response,C66742,6,SDTMIG v3.3,SR,,,,,N; Y; U,C49487; C49488; C17998,SRTESTCD EQ "BLISTIND",SRTEST EQ "Blistering Indicator",C122195,text,C122195,
SIZE,SRSTRESC,Size Response,C66733,7,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "FLARESZ",SRTEST EQ "Flare Size",C112283,text,C112283,
,SRSTRESC,,,8,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "FLRLDIAM",SRTEST EQ "Flare Longest Diameter",C112281,float,C112281,
UNIT,SRSTRESU,Unit,C71620,9,SDTMIG v3.3,SR,,,,,cm; in; mm,C49668; C48500; C28251,SRTESTCD EQ "FLRLDIAM",SRTEST EQ "Flare Longest Diameter",C112281,text,C112281,
,SRSTRESC,,,10,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "FLRMDIAM",SRTEST EQ "Flare Mean Diameter",C112282,float,C112282,
UNIT,SRSTRESU,Unit,C71620,11,SDTMIG v3.3,SR,,,,,cm; in; mm,C49668; C48500; C28251,SRTESTCD EQ "FLRMDIAM",SRTEST EQ "Flare Mean Diameter",C112282,text,C112282,
,SRSTRESC,,,12,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "IDRLDIAM",SRTEST EQ "Induration Longest Diameter",C122196,float,C122196,
UNIT,SRSTRESU,Unit,C71620,13,SDTMIG v3.3,SR,,,,,cm; in; mm,C49668; C48500; C28251,SRTESTCD EQ "IDRLDIAM",SRTEST EQ "Induration Longest Diameter",C122196,text,C122196,
,SRSTRESC,,,14,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "INTP",SRTEST EQ "Interpretation",C41255,text,C41255,
,SRSTRESC,,,15,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "REACTGR",SRTEST EQ "Reaction Grade",C179819,text,C179819,
SIZE,SRSTRESC,Size Response,C66733,16,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "WHEALSZ",SRTEST EQ "Wheal Size",C112429,text,C112429,
,SRSTRESC,,,17,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "WHLINT",SRTEST EQ "Wheal Diameter Interpretation",C130186,text,C130186,
,SRSTRESC,,,18,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "WHLLDIAM",SRTEST EQ "Wheal Longest Diameter",C112427,float,C112427,
UNIT,SRSTRESU,Unit,C71620,19,SDTMIG v3.3,SR,,,,,cm; in; mm,C49668; C48500; C28251,SRTESTCD EQ "WHLLDIAM",SRTEST EQ "Wheal Longest Diameter",C112427,text,C112427,
,SRSTRESC,,,20,SDTMIG v3.3,SR,,,,,,,SRTESTCD EQ "WHLMDIAM",SRTEST EQ "Wheal Mean Diameter",C112428,float,C112428,
UNIT,SRSTRESU,Unit,C71620,21,SDTMIG v3.3,SR,,,,,cm; in; mm,C49668; C48500; C28251,SRTESTCD EQ "WHLMDIAM",SRTEST EQ "Wheal Mean Diameter",C112428,text,C112428,
UNIT,SRORRESU,Unit,C71620,22,SDTMIG v3.3,SR,,,,,,,,,,,,
UNIT,SRSTRESU,Unit,C71620,23,SDTMIG v3.3,SR,,,,,,,,,,,,
ND,SRSTAT,Not Done,C66789,24,SDTMIG v3.3,SR,,,,,,,,,,,,
LOC,SRLOC,Anatomical Location,C74456,25,SDTMIG v3.3,SR,,,,,,,,,,,,
LAT,SRLAT,Laterality,C99073,26,SDTMIG v3.3,SR,,,,,,,,,,,,
METHOD,SRMETHOD,Method,C85492,27,SDTMIG v3.3,SR,,,,,,,,,,,,
EVAL,SREVAL,Evaluator,C78735,28,SDTMIG v3.3,SR,,,,,,,,,,,,
MEDEVAL,SREVALID,Medical Evaluator,C96777,29,SDTM v1.7,SR,,,,,,,,,,,,
DIR,SRDIR,Directionality,C99074,30,SDTM v1.7,SR,,,,,,,,,,,,
NY,SRBLFL,No Yes Response,C66742,31,SDTMIG v3.3,SR,,,,,Y,C49488,,,,,,
NY,SRDRVFL,No Yes Response,C66742,32,SDTM v1.7,SR,,,,,Y,C49488,,,,,,
NY,SRACPTFL,No Yes Response,C66742,33,SDTM v1.7,SR,,,,,Y,C49488,,,,,,
PORTOT,SRPORTOT,Portion/Totality,C99075,34,SDTM v1.7,SR,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,35,SDTMIG v3.3,SR,,,,,,,,,,,,
,SRLOINC,,,36,SDTM v1.7,SR,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SS,,,,,SS,C117655,,,,,,
SSTESTCD,SSTESTCD,Subject Status Test Code,C124305,2,SDTMIG v3.3,SS,,,,,,,,,,,,
SSTEST,SSTEST,Subject Status Test Name,C124306,3,SDTMIG v3.3,SS,,,,,,,,,,,,
SSTATRS,SSSTRESC,Subject Status Response,C124304,4,SDTMIG v3.3,SS,,,,,,,SSTESTCD EQ "SURVSTAT",SSTEST EQ "Survival Status",C25717,,C25717,
ND,SSSTAT,Not Done,C66789,5,SDTMIG v3.3,SS,,,,,,,,,,,,
EVAL,SSEVAL,Evaluator,C78735,6,SDTMIG v3.3,SS,,,,,,,,,,,,
MEDEVAL,SSEVALID,Medical Evaluator,C96777,7,SDTM v1.7,SS,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,8,SDTMIG v3.3,SS,,,,,,,,,,,,
,SSLOINC,,,9,SDTM v1.7,SS,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TR,,,,,TR,C106578,,,,,,
TRTEST,TRTEST,Tumor or Lesion Properties Test Name,C96778,2,SDTMIG v3.3,TR,,,,,,,,,,,,
TRTESTCD,TRTESTCD,Tumor or Lesion Properties Test Code,C96779,3,SDTMIG v3.3,TR,,,,,,,,,,,,
TRPROPRS,TRSTRESC,Tumor or Lesion Properties Test Result,C124309,4,SDTMIG v3.3,TR,,,,,,,,,,,,
UNIT,TRORRESU,Unit,C71620,5,SDTMIG v3.3,TR,,,,,,,,,,,,
UNIT,TRSTRESU,Unit,C71620,6,SDTMIG v3.3,TR,,,,,,,,,,,,
ND,TRSTAT,Not Done,C66789,7,SDTMIG v3.3,TR,,,,,,,,,,,,
METHOD,TRMETHOD,Method,C85492,8,SDTMIG v3.3,TR,,,,,,,,,,,,
EVAL,TREVAL,Evaluator,C78735,9,SDTMIG v3.3,TR,,,,,,,,,,,,
MEDEVAL,TREVALID,Medical Evaluator,C96777,10,SDTMIG v3.3,TR,,,,,,,,,,,,
NY,TRACPTFL,No Yes Response,C66742,11,SDTMIG v3.3,TR,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,12,SDTMIG v3.3,TR,,,,,,,,,,,,
,TRLOINC,,,13,SDTM v1.7,TR,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
NY,TRBLFL,No Yes Response,C66742,14,SDTMIG v3.3,TR,,,,,Y,C49488,,,,,,
NY,TRDRVFL,No Yes Response,C66742,15,SDTM v1.7,TR,,,,,Y,C49488,,,,,,
NY,TRLOBXFL,No Yes Response,C66742,16,SDTMIG v3.3,TR,,,,,Y,C49488,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TU,,,,,TU,C106577,,,,,,
TUTEST,TUTEST,Tumor or Lesion Identification Test Name,C96783,2,SDTMIG v3.3,TU,,,,,,,,,,,,
TUTESTCD,TUTESTCD,Tumor or Lesion Identification Test Code,C96784,3,SDTMIG v3.3,TU,,,,,,,,,,,,
TUIDRS,TUSTRESC,Tumor or Lesion Identification Test Results,C123650,4,SDTMIG v3.3,TU,,,,,,,,,,,,
LOC,TULOC,Anatomical Location,C74456,5,SDTMIG v3.3,TU,,,,,,,,,,,,
LAT,TULAT,Laterality,C99073,6,SDTMIG v3.3,TU,,,,,,,,,,,,
DIR,TUDIR,Directionality,C99074,7,SDTMIG v3.3,TU,,,,,,,,,,,,
PORTOT,TUPORTOT,Portion/Totality,C99075,8,SDTMIG v3.3,TU,,,,,,,,,,,,
METHOD,TUMETHOD,Method,C85492,9,SDTMIG v3.3,TU,,,,,,,,,,,,
EVAL,TUEVAL,Evaluator,C78735,10,SDTMIG v3.3,TU,,,,,,,,,,,,
MEDEVAL,TUEVALID,Medical Evaluator,C96777,11,SDTMIG v3.3,TU,,,,,,,,,,,,
NY,TUACPTFL,No Yes Response,C66742,12,SDTMIG v3.3,TU,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,13,SDTMIG v3.3,TU,,,,,,,,,,,,
ND,TUSTAT,Not Done,C66789,14,SDTM v1.7,TU,,,,,,,,,,,,
NY,TUBLFL,No Yes Response,C66742,15,SDTMIG v3.3,TU,,,,,Y,C49488,,,,,,
NY,TULOBXFL,No Yes Response,C66742,16,SDTMIG v3.3,TU,,,,,Y,C49488,,,,,,
NY,SUPPTU.QVAL,No Yes Response,C66742,17,SDTMIG v3.3,TU,,,,,,,SUPPTU.QNAM EQ "PREVIR",SUPPTU.QLABEL EQ "Previously Irradiated",,,,
NY,SUPPTU.QVAL,No Yes Response,C66742,18,SDTMIG v3.3,TU,,,,,,,SUPPTU.QNAM EQ "PREVIRP",SUPPTU.QLABEL EQ "Irradiated then Subsequent Progression",,,,
GRAFTTYP,SUPPTU.QVAL,Graft Type,C117737,19,TAUG-CV v1.0,TU,,,,,,,SUPPTU.QNAM EQ "TUCAGT",SUPPTU.QLABEL EQ "Coronary Artery Graft Type",,,,
GRAFTTYP,SUPPTU.QVAL,Graft Type,C117737,20,TAUG-CV v1.0,TU,,,,,,,SUPPTU.QNAM EQ "TUPAGT",SUPPTU.QLABEL EQ "Peripheral Artery Graft Type",,,,
DSPRTYP,SUPPTU.QVAL,Disease Presentation Type,C127268,21,TAUG-BrCa v1.0; TAUG-LuCa v1.0,TU,,,,,,,SUPPTU.QNAM EQ "TUPRTYP",SUPPTU.QLABEL EQ "Tumor or Lesion Presentation Type",,,,
LOC,SUPPTU.QVAL,Anatomical Location,C74456,22,TAUG-CV v1.0,TU,,,,,,,SUPPTU.QNAM EQ "CAGAMAST",SUPPTU.QLABEL EQ "Coronary Artery Graft Anastomosis",,,,
LOC,SUPPTU.QVAL,Anatomical Location,C74456,23,TAUG-CV v1.0,TU,,,,,,,SUPPTU.QNAM EQ "PAGAMAST",SUPPTU.QLABEL EQ "Peripheral Artery Graft Anastomosis",,,,
GRAFTTYP,SUPPTU.QVAL,Graft Type,C117737,24,TAUG-CV v1.0,TU,,,,,,,SUPPTU.QNAM EQ "CAGT",SUPPTU.QLABEL EQ "Coronary Artery Graft Type",,,,
GRAFTTYP,SUPPTU.QVAL,Graft Type,C117737,25,TAUG-CV v1.0,TU,,,,,,,SUPPTU.QNAM EQ "PAGT",SUPPTU.QLABEL EQ "Peripheral Artery Graft Type",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,UR,,,,,UR,C102726,,,,,,
URNSTSCD,URTESTCD,Urinary System Test Code,C129942,2,SDTMIG v3.3,UR,,,,,,,,,,,,
URNSTS,URTEST,Urinary System Test Name,C129941,3,SDTMIG v3.3,UR,,,,,,,,,,,,
UNIT,URORRESU,Unit,C71620,4,SDTMIG v3.3,UR,,,,,,,,,,,,
UNIT,URSTRESU,Unit,C71620,5,SDTMIG v3.3,UR,,,,,,,,,,,,
ND,URSTAT,Not Done,C66789,6,SDTMIG v3.3,UR,,,,,,,,,,,,
SPECTYPE,URSPEC,Specimen Type,C78734,7,SDTMIG v3.3,UR,,,,,,,,,,,,
NY,URSPCUFL,No Yes Response,C66742,8,SDTMIG v3.3,UR,,,,,N,C49487,,,,,,
LOC,URLOC,Anatomical Location,C74456,9,SDTMIG v3.3,UR,,,,,,,,,,,,
LAT,URLAT,Laterality,C99073,10,SDTMIG v3.3,UR,,,,,,,,,,,,
DIR,URDIR,Directionality,C99074,11,SDTMIG v3.3,UR,,,,,,,,,,,,
METHOD,URMETHOD,Method,C85492,12,SDTMIG v3.3,UR,,,,,,,,,,,,
NY,URLOBXFL,No Yes Response,C66742,13,SDTMIG v3.3,UR,,,,,Y,C49488,,,,,,
NY,URBLFL,No Yes Response,C66742,14,SDTMIG v3.3,UR,,,,,Y,C49488,,,,,,
NY,URDRVFL,No Yes Response,C66742,15,SDTMIG v3.3,UR,,,,,Y,C49488,,,,,,
EVAL,UREVAL,Evaluator,C78735,16,SDTMIG v3.3,UR,,,,,,,,,,,,
MEDEVAL,UREVALID,Medical Evaluator,C96777,17,SDTMIG v3.3,UR,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,18,SDTMIG v3.3,UR,,,,,,,,,,,,
NY,URACPTFL,No Yes Response,C66742,19,SDTM v1.7,UR,,,,,N; Y,C49487; C49488,,,,,,
PORTOT,URPORTOT,Portion/Totality,C99075,20,SDTM v1.7,UR,,,,,,,,,,,,
,URLOINC,,,21,SDTM v1.7,UR,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
SPECCOND,URSPCCND,Specimen Condition,C78733,22,SDTM v1.7,UR,,,,,,,,,,,,
SEVRS,URSEV,Severity Response,C165643,23,SDTM v1.7,UR,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,VS,,,,,VS,C49622,,,,,,
VSTESTCD,VSTESTCD,Vital Signs Test Code,C66741,2,SDTMIG v3.3,VS,,,,,,,,,,,,
VSTEST,VSTEST,Vital Signs Test Name,C67153,3,SDTMIG v3.3,VS,,,,,,,,,,,,
VSRESU,VSORRESU,Units for Vital Signs Results,C66770,4,SDTMIG v3.3,VS,,,,,,,,,,,,
VSRESU,VSSTRESU,Units for Vital Signs Results,C66770,5,SDTMIG v3.3,VS,,,,,,,,,,,,
ND,VSSTAT,Not Done,C66789,6,SDTMIG v3.3,VS,,,,,,,,,,,,
NY,VSBLFL,No Yes Response,C66742,7,SDTMIG v3.3,VS,,,,,Y,C49488,,,,,,
NY,VSDRVFL,No Yes Response,C66742,8,SDTMIG v3.3,VS,,,,,Y,C49488,,,,,,
POSITION,VSPOS,Position,C71148,9,SDTMIG v3.3,VS,,,,,,,,,,,,
,VSLOINC,,,10,SDTM v1.7,VS,LOINC Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://loinc.org/",Regenstrief Institute,Logical Observation Identifiers Names and Codes (LOINC),,,,,,,,
LOC,VSLOC,Anatomical Location,C74456,11,SDTMIG v3.3,VS,,,,,,,,,,,,
LAT,VSLAT,Laterality,C99073,12,SDTMIG v3.3,VS,,,,,,,,,,,,
DIR,VSDIR,Directionality,C99074,13,SDTM v1.7,VS,,,,,,,,,,,,
METHOD,VSMETHOD,Method,C85492,14,SDTM v1.7,VS,,,,,,,,,,,,
EVAL,VSEVAL,Evaluator,C78735,15,SDTM v1.7,VS,,,,,,,,,,,,
MEDEVAL,VSEVALID,Medical Evaluator,C96777,16,SDTM v1.7,VS,,,,,,,,,,,,
NY,VSACPTFL,No Yes Response,C66742,17,SDTM v1.7,VS,,,,,Y,C49488,,,,,,
EPOCH,EPOCH,Epoch,C99079,18,SDTMIG v3.3,VS,,,,,,,,,,,,
NY,VSLOBXFL,No Yes Response,C66742,19,SDTMIG v3.3,VS,,,,,Y,C49488,,,,,,
COLSTYP,SUPPVS.QVAL,Collected Summarized Value Type Response,C177908,20,TAUG-Vaccines v1.1,VS,,,,,,,SUPPVS.QNAM EQ "COLSRT",SUPPVS.QLABEL EQ "Collected Summary Result Type",,,,
COLSTYP,SUPPVS.QVAL,Collected Summarized Value Type Response,C177908,21,TAUG-T1D-SSM v1.0; TAUG-T1D-ENM v1.0,VS,,,,,,,SUPPVS.QNAM EQ "COLSRT",SUPPVS.QLABEL EQ "Collected Summary Result Type",,,,
NY,SUPPVS.QVAL,No Yes Response,C66742,22,TAUG-T1D-ENM v1.0,VS,,,,,,,SUPPVS.QNAM EQ "RECVFL",SUPPVS.QLABEL EQ "Record Validity Flag",,,,
SETTING,SUPPVS.QVAL,Environmental Setting,C127262,23,TAUG-T1D-ENM v1.0,VS,,,,,,,SUPPVS.QNAM EQ "SETTING",SUPPVS.QLABEL EQ "Environmental Setting",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,AG,,,,,AG,C117755,,,,,,
NY,AGPRESP,No Yes Response,C66742,2,SDTMIG v3.3,AG,,,,,Y,C49488,,,,,,
NY,AGOCCUR,No Yes Response,C66742,3,SDTMIG v3.3,AG,,,,,N; Y,C49487; C49488,,,,,,
ND,AGSTAT,Not Done,C66789,4,SDTMIG v3.3,AG,,,,,,,,,,,,
UNIT,AGDOSU,Unit,C71620,5,SDTMIG v3.3,AG,,,,,,,,,,,,
FRM,AGDOSFRM,Pharmaceutical Dosage Form,C66726,6,SDTMIG v3.3,AG,,,,,,,,,,,,
FREQ,AGDOSFRQ,Frequency,C71113,7,SDTMIG v3.3,AG,,,,,,,,,,,,
ROUTE,AGROUTE,Route of Administration Response,C66729,8,SDTMIG v3.3,AG,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,9,SDTMIG v3.3,AG,,,,,,,,,,,,
STENRF,AGSTRF,Relation to Reference Period,C66728,10,SDTMIG v3.3,AG,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,AGENRF,Relation to Reference Period,C66728,11,SDTMIG v3.3,AG,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,AGSTRTPT,Relation to Reference Period,C66728,12,SDTMIG v3.3,AG,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,AGENRTPT,Relation to Reference Period,C66728,13,SDTMIG v3.3,AG,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
LOC,AGLOC,Anatomical Location,C74456,14,SDTM v1.7,AG,,,,,,,,,,,,
LAT,AGLAT,Laterality,C99073,15,SDTM v1.7,AG,,,,,,,,,,,,
DIR,AGDIR,Directionality,C99074,16,SDTM v1.7,AG,,,,,,,,,,,,
NY,AGFAST,No Yes Response,C66742,17,SDTM v1.7,AG,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
UNIT,AGVAMTU,Unit,C71620,18,SDTM v1.7,AG,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,CM,,,,,CM,C49568,,,,,,
,CMDECOD,,,2,SDTMIG v3.3,CM,WHODrug drug name,"Listed in US FDA and Japan PMDA Data Standards Catalogs. As per US FDA Data Standards Catalog, support for WHODrug Dictionary ends March 15 2019 and support for WHODrug Global begins March 15 2019. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Dictionary,,,,,,,,
,CMDECOD,,,3,SDTMIG v3.3,CM,WHODrug drug name,"Listed in US FDA Data Standards Catalog, which states that support for WHODD ends 15 March. 2019 and support for WHODrug Global begins 15 March, 2019. \n Listed in Japan PMDA data standards catalog, which states that support for WHO Drug Dictionary Enhanced and WHODrug Global begins October 01, 2016. Ref: https://www.pmda.go.jp/files/000232074.zip \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
,CMDECOD,,,4,SDTMIG v3.3,CM,Unique Ingredient Identifier (UNII),"Listed in US FDA Data Standards Catalog: ""After UNII is assigned, use UNII in SDTM and SEND TS domain for TSVAL where TSPARMCD is any of the following: TRT, CURTRT, COMPTRT. Use also in CMDECOD."" \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,,,,,,
NY,CMPRESP,No Yes Response,C66742,5,SDTMIG v3.3,CM,,,,,Y,C49488,,,,,,
NY,CMOCCUR,No Yes Response,C66742,6,SDTMIG v3.3,CM,,,,,N; Y,C49487; C49488,,,,,,
ND,CMSTAT,Not Done,C66789,7,SDTMIG v3.3,CM,,,,,,,,,,,,
,CMCLAS,,,8,SDTMIG v3.3,CM,Anatomical Therapeutic Chemical Classification (ATC),"Listed in US FDA Data Standards Catalog, which states that support for WHODD ends March 15 2019 and support for WHODrug Global begins March 15 2019. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
,CMCLAS,,,9,SDTMIG v3.3,CM,Anatomical Therapeutic Chemical Classification (ATC),"Listed in US FDA and Japan PMDA data standards catalogs. As per US FDA Data Standards Catalog, support for WHODrug Dictionary ends March 15 2019 and support for WHODrug Global begins March 15 2019. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Dictionary,,,,,,,,
,CMCLAS,,,10,SDTMIG v3.3,CM,RxNorm clinical drug name,"Listed in US FDA Data Standards Catalog. Used to be named NDF-RT. \n From US FDA Data Standards Catalog: ""Use in SDTM and SEND TS domain for TSVAL where TSPARMCD=PCLAS and TSPARM = Pharmacologic Class. Use FDA established Pharmacologic Class for all FDA approved moieties (see References). Use also in SDTM CMCLAS."" \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://evs.nci.nih.gov/ftp1/MED-RT/medrt_about.html","Department of Veterans Affairs, Structured Product Labeling Interagency Expert Panel (SPLIEP)",Medication Reference Terminology (MED-RT),,,,,,,,
,CMCLASCD,,,11,SDTMIG v3.3,CM,Anatomical Therapeutic Chemical Classification Code (ATCCD),"Listed in US FDA Data Standards Catalog, which states that support for WHODD ends March 15 2019 and support for WHODrug Global begins March 15 2019. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
,CMCLASCD,,,12,SDTMIG v3.3,CM,Anatomical Therapeutic Chemical Classification Code (ATCCD),"Listed in US FDA and Japan PMDA data standards catalogs. As per US FDA Data Standards Catalog, support for WHODrug Dictionary ends March 15 2019 and support for WHODrug Global begins March 15 2019. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Dictionary,,,,,,,,
,CMCLASCD,,,13,SDTMIG v3.3,CM,RxNorm clinical drug name,"Listed in US FDA Data Standards Catalog. Used to be named NDF-RT. \n From US FDA Data Standards Catalog: ""Use in SDTM and SEND TS domain for TSVAL where TSPARMCD=PCLAS and TSPARM = Pharmacologic Class. Use FDA established Pharmacologic Class for all FDA approved moieties (see References). Use also in SDTM CMCLAS."" \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/","Department of Veterans Affairs, Structured Product Labeling Interagency Expert Panel (SPLIEP)",Medication Reference Terminology (MED-RT),,,,,,,,
UNIT,CMDOSU,Unit,C71620,14,SDTMIG v3.3,CM,,,,,,,,,,,,
FRM,CMDOSFRM,Pharmaceutical Dosage Form,C66726,15,SDTMIG v3.3,CM,,,,,,,,,,,,
FREQ,CMDOSFRQ,Frequency,C71113,16,SDTMIG v3.3,CM,,,,,,,,,,,,
ROUTE,CMROUTE,Route of Administration Response,C66729,17,SDTMIG v3.3,CM,,,,,,,,,,,,
STENRF,CMSTRF,Relation to Reference Period,C66728,18,SDTMIG v3.3,CM,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,CMENRF,Relation to Reference Period,C66728,19,SDTMIG v3.3,CM,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,CMSTRTPT,Relation to Reference Period,C66728,20,SDTMIG v3.3,CM,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,CMENRTPT,Relation to Reference Period,C66728,21,SDTMIG v3.3,CM,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
LOC,CMLOC,Anatomical Location,C74456,22,SDTM v1.7,CM,,,,,,,,,,,,
LAT,CMLAT,Laterality,C99073,23,SDTM v1.7,CM,,,,,,,,,,,,
DIR,CMDIR,Directionality,C99074,24,SDTM v1.7,CM,,,,,,,,,,,,
NY,CMFAST,No Yes Response,C66742,25,SDTM v1.7,CM,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
UNIT,CMPSTRGU,Unit,C71620,26,SDTM v1.7,CM,,,,,,,,,,,,
UNIT,CMVAMTU,Unit,C71620,27,SDTM v1.7,CM,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,28,SDTM v1.7,CM,,,,,,,,,,,,
VCNEVD,SUPPCM.QVAL,Vaccination Evidence Source,C102590,29,TAUG-TB v2.0,CM,,,,,,,SUPPCM.QNAM EQ "VCNEVD",SUPPCM.QLABEL EQ "Vaccination Evidence Source",,,,
TRTSET,SUPPCM.QVAL,Treatment Setting,C124308,30,TAUG-BrCa v1.0,CM,,,,,,,SUPPCM.QNAM EQ "TRTSTT",SUPPCM.QLABEL EQ "Setting",,,,
TRTINTNT,SUPPCM.QVAL,Treatment Intent,C124307,31,TAUG-BrCa v1.0,CM,,,,,,,SUPPCM.QNAM EQ "TRTINT",SUPPCM.QLABEL EQ "Treatment Intent",,,,
REASTRT,SUPPCM.QVAL,Reason For Treatment,C102584,32,TAUG-TB v2.0,CM,,,,,,,SUPPCM.QNAM EQ "REASTRT",SUPPCM.QLABEL EQ "Reason for Treatment",,,,
EVDRETRT,SUPPCM.QVAL,Supporting Evidence for Re-Treatment,C102579,33,TAUG-CHCV v1.0,CM,,,,,,,SUPPCM.QNAM EQ "EVDRETRT",SUPPCM.QLABEL EQ "Supporting Evidence for Retreatment",,,,
AVOUTTRT,SUPPCM.QVAL,Anti-Viral Outcome of Treatment,C120521,34,TAUG-CHCV v1.0,CM,,,,,,,SUPPCM.QNAM EQ "OUTTRT",SUPPCM.QLABEL EQ "Outcome of Treatment",,,,
NY,SUPPCM.QVAL,No Yes Response,C66742,35,TAUG-TB v2.0,CM,,,,,Y,C49488,SUPPCM.QNAM EQ "BCGSRIND",SUPPCM.QLABEL EQ "BCG Scar Present Indicator",,,,
NY,SUPPCM.QVAL,No Yes Response,C66742,36,TAUG-TB v2.0,CM,,,,,Y,C49488,SUPPCM.QNAM EQ "DOTIND",SUPPCM.QLABEL EQ "Directly Observed Therapy Indicator",,,,
SETTING,SUPPCM.QVAL,Environmental Setting,C127262,37,TAUG-TB v2.0,CM,,,,,,,SUPPCM.QNAM EQ "DOTSET",SUPPCM.QLABEL EQ "Directly Observed Therapy Setting",,,,
SETTING,SUPPCM.QVAL,Environmental Setting,C127262,38,TAUG-LuCa v1.0,CM,,,,,,,SUPPCM.QNAM EQ "SETTNG","SUPPCM.QLABEL EQ ""Setting of Event, Intervention, Finding""",,,,
TRTSET,SUPPCM.QVAL,Treatment Setting,C124308,39,TAUG-TB v2.0,CM,,,,,,,SUPPCM.QNAM EQ "PRTRTPRD",SUPPCM.QLABEL EQ "Prior Treatment Period",,,,
NY,SUPPCM.QVAL,No Yes Response,C66742,40,TAUG HF v1.0,CM,,,,,,,SUPPCM.QNAM EQ "CMRRGYN",SUPPCM.QLABEL EQ "Prescribed Recommended Regimen Indicator",,,,
COLSTYP,SUPPCM.QVAL,Collected Summarized Value Type Response,C177908,41,TAUG T1D-PDM v2.0,CM,,,,,,,SUPPCM.QNAM EQ "COLSDT",SUPPCM.QLABEL EQ "Collected Summary Dose Type",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DX,,,,,DX,C102617,,,,,,
,DXTRT,,,2,SDTMIG-MD v1.1,DX,GMDN Term Name,"US FDA CDRH encourages the use of GMDN. \n Link to general information about the cited external dictionary, accessed 2022-06-16: https://www.gmdnagency.org/assets/about/resources/GMDN Agency Terms Data Export Field Descriptions 2021-06-04.pdf",GMDN Agency,Global Medical Device Nomenclature (GMDN),,,,,,,,
,DXTRT,,,3,SDTMIG-MD v1.1,DX,Term,"Enter Term to DXTRT. FDA Code, NCIt Code, and IMDFR Code may optionally go to the SUPPDX dataset. \n Terminology files are available through NCI EVS FTP here: https://evs.nci.nih.gov/ftp1/FDA/CDRH/About.html \n Link to general information about the cited external dictionary, accessed 2022-06-16: https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources-medical-device-reports",U.S. Food and Drug Administration (US FDA),Medical Device Report Annex G: Medical Device Component,,,,,,,,
UNIT,DXDOSU,Unit,C71620,4,SDTMIG-MD v1.1,DX,,,,,,,,,,,,
FREQ,DXDOSFRQ,Frequency,C71113,5,SDTMIG-MD v1.1,DX,,,,,,,,,,,,
ROUTE,DXROUTE,Route of Administration Response,C66729,6,SDTMIG-MD v1.1,DX,,,,,,,,,,,,
LOC,DXLOC,Anatomical Location,C74456,7,SDTMIG-MD v1.1,DX,,,,,,,,,,,,
LAT,DXLAT,Laterality,C99073,8,SDTMIG-MD v1.1,DX,,,,,,,,,,,,
DIR,DXDIR,Directionality,C99074,9,SDTM v1.7,DX,,,,,,,,,,,,
PORTOT,DXPORTOT,Portion/Totality,C99075,10,SDTM v1.7,DX,,,,,,,,,,,,
NY,DXPRESP,No Yes Response,C66742,11,SDTM v1.7,DX,,,,,Y,C49488,,,,,,
NY,DXOCCUR,No Yes Response,C66742,12,SDTM v1.7,DX,,,,,N; Y,C49487; C49488,,,,,,
ND,DXSTAT,Not Done,C66789,13,SDTM v1.7,DX,,,,,,,,,,,,
UNIT,DXVAMTU,Unit,C71620,14,SDTM v1.7,DX,,,,,,,,,,,,
EVAL,SUPPDX.QVAL,Evaluator,C78735,15,TAUG-HIV v1.0,DX,,,,,,,SUPPDX.QNAM EQ "INSROL",SUPPDX.QLABEL EQ "Role of Person who Inserted the Device",,,,
EVAL,SUPPDX.QVAL,Evaluator,C78735,16,TAUG-HIV v1.0,DX,,,,,,,SUPPDX.QNAM EQ "RMVROL",SUPPDX.QLABEL EQ "Role of Person who Removed the Device",,,,
NY,SUPPDX.QVAL,No Yes Response,C66742,17,TAUG-HIV v1.0,DX,,,,,,,SUPPDX.QNAM EQ "RNSIND",SUPPDX.QLABEL EQ "Device Rinsed Indicator",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,EC,,,,,EC,C117466,,,,,,
BRDGMOOD,ECMOOD,BRIDG Activity Mood,C125923,2,SDTMIG v3.3,EC,,,,,,,,,,,,
NY,ECPRESP,No Yes Response,C66742,3,SDTMIG v3.3,EC,,,,,Y,C49488,,,,,,
NY,ECOCCUR,No Yes Response,C66742,4,SDTMIG v3.3,EC,,,,,N; Y,C49487; C49488,,,,,,
UNIT,ECDOSU,Unit,C71620,5,SDTMIG v3.3,EC,,,,,,,,,,,,
FRM,ECDOSFRM,Pharmaceutical Dosage Form,C66726,6,SDTMIG v3.3,EC,,,,,,,,,,,,
FREQ,ECDOSFRQ,Frequency,C71113,7,SDTMIG v3.3,EC,,,,,,,,,,,,
ROUTE,ECROUTE,Route of Administration Response,C66729,8,SDTMIG v3.3,EC,,,,,,,,,,,,
LOC,ECLOC,Anatomical Location,C74456,9,SDTMIG v3.3,EC,,,,,,,,,,,,
LAT,ECLAT,Laterality,C99073,10,SDTMIG v3.3,EC,,,,,,,,,,,,
DIR,ECDIR,Directionality,C99074,11,SDTMIG v3.3,EC,,,,,,,,,,,,
PORTOT,ECPORTOT,Portion/Totality,C99075,12,SDTMIG v3.3,EC,,,,,,,,,,,,
NY,ECFAST,No Yes Response,C66742,13,SDTMIG v3.3,EC,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
UNIT,ECPSTRGU,Unit,C71620,14,SDTMIG v3.3,EC,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,15,SDTMIG v3.3,EC,,,,,,,,,,,,
NY,SUPPEC.QVAL,No Yes Response,C66742,16,TAUG-Malaria v1.0,EC,,,,,,,SUPPEC.QNAM EQ "RDIND",SUPPEC.QLABEL EQ "Redose Indicator",,,,
NY,SUPPEC.QVAL,No Yes Response,C66742,17,TAUG-Malaria v1.0,EC,,,,,,,SUPPEC.QNAM EQ "DOTIND",SUPPEC.QLABEL EQ "Directly Observed Therapy Indicator",,,,
NY,SUPPEC.QVAL,No Yes Response,C66742,18,TAUG-PanCan v1.0,EC,,,,,,,SUPPEC.QNAM EQ "INFIRP",SUPPEC.QLABEL EQ "Infusion Interrupted",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,EX,,,,,EX,C49587,,,,,,
UNIT,EXDOSU,Unit,C71620,2,SDTMIG v3.3,EX,,,,,,,,,,,,
FRM,EXDOSFRM,Pharmaceutical Dosage Form,C66726,3,SDTMIG v3.3,EX,,,,,,,,,,,,
FREQ,EXDOSFRQ,Frequency,C71113,4,SDTMIG v3.3,EX,,,,,,,,,,,,
ROUTE,EXROUTE,Route of Administration Response,C66729,5,SDTMIG v3.3,EX,,,,,,,,,,,,
LOC,EXLOC,Anatomical Location,C74456,6,SDTMIG v3.3,EX,,,,,,,,,,,,
LAT,EXLAT,Laterality,C99073,7,SDTMIG v3.3,EX,,,,,,,,,,,,
DIR,EXDIR,Directionality,C99074,8,SDTMIG v3.3,EX,,,,,,,,,,,,
PORTOT,EXPORTOT,Portion/Totality,C99075,9,SDTM v1.7,EX,,,,,,,,,,,,
NY,EXFAST,No Yes Response,C66742,10,SDTMIG v3.3,EX,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
UNIT,EXPSTRGU,Unit,C71620,11,SDTM v1.7,EX,,,,,,,,,,,,
UNIT,EXVAMTU,Unit,C71620,12,SDTM v1.7,EX,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,13,SDTMIG v3.3,EX,,,,,,,,,,,,
NY,SUPPEX.QVAL,No Yes Response,C66742,14,TAUG-EVD v1.0,EX,,,,,N; Y; U,C49487; C49488; C17998,SUPPEX.QNAM EQ "RDIND",SUPPEX.QLABEL EQ "Redose Indicator",,,,
REASTINT,SUPPEX.QVAL,Reason for Treatment Interruption,C102583,15,TAUG-TB v2.0,EX,,,,,,,SUPPEX.QNAM EQ "REASINT",SUPPEX.QLABEL EQ "Reason for Interruption",,,,
NY,SUPPEX.QVAL,No Yes Response,C66742,16,TAUG-PanCan v1.0,EX,,,,,,,SUPPEX.QNAM EQ "INFIRP",SUPPEX.QLABEL EQ "Infusion Interrupted",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,ML,,,,,ML,C49604,,,,,,
NY,MLPRESP,No Yes Response,C66742,2,SDTMIG v3.3,ML,,,,,Y,C49488,,,,,,
NY,MLOCCUR,No Yes Response,C66742,3,SDTMIG v3.3,ML,,,,,N; Y,C49487; C49488,,,,,,
ND,MLSTAT,Not Done,C66789,4,SDTMIG v3.3,ML,,,,,,,,,,,,
UNIT,MLDOSU,Unit,C71620,5,SDTMIG v3.3,ML,,,,,,,,,,,,
FRM,MLDOSFRM,Pharmaceutical Dosage Form,C66726,6,SDTMIG v3.3,ML,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,7,SDTMIG v3.3,ML,,,,,,,,,,,,
STENRF,MLSTRF,Relation to Reference Period,C66728,8,SDTM v1.7,ML,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MLENRF,Relation to Reference Period,C66728,9,SDTM v1.7,ML,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,MLSTRTPT,Relation to Reference Period,C66728,10,SDTM v1.7,ML,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,MLENRTPT,Relation to Reference Period,C66728,11,SDTM v1.7,ML,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
ROUTE,MLROUTE,Route of Administration Response,C66729,12,SDTM v1.7,ML,,,,,,,,,,,,
NY,MLFAST,No Yes Response,C66742,13,SDTM v1.7,ML,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
FREQ,MLDOSFRQ,Frequency,C71113,14,SDTM v1.7,ML,,,,,,,,,,,,
SETTING,SUPPML.QVAL,Environmental Setting,C127262,15,TAUG-T1D-ENM v1.0,ML,,,,,,,SUPPML.QNAM EQ "SETTING",SUPPML.QLABEL EQ "Environmental Setting",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,PR,,,,,PR,C102700,,,,,,
PROCEDUR,PRDECOD,Procedure,C101858,2,SDTMIG v3.3,PR,,,,,,,,,,,,
DIR,PRDIR,Directionality,C99074,3,SDTM v1.7,PR,,,,,,,,,,,,
FRM,PRDOSFRM,Pharmaceutical Dosage Form,C66726,4,SDTMIG v3.3,PR,,,,,,,,,,,,
FREQ,PRDOSFRQ,Frequency,C71113,5,SDTMIG v3.3,PR,,,,,,,,,,,,
UNIT,PRDOSU,Unit,C71620,6,SDTMIG v3.3,PR,,,,,,,,,,,,
STENRF,PRENRTPT,Relation to Reference Period,C66728,7,SDTMIG v3.3,PR,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
LAT,PRLAT,Laterality,C99073,8,SDTM v1.7,PR,,,,,,,,,,,,
LOC,PRLOC,Anatomical Location,C74456,9,SDTM v1.7,PR,,,,,,,,,,,,
NY,PROCCUR,No Yes Response,C66742,10,SDTMIG v3.3,PR,,,,,N; Y,C49487; C49488,,,,,,
PORTOT,PRPORTOT,Portion/Totality,C99075,11,SDTM v1.7,PR,,,,,,,,,,,,
NY,PRPRESP,No Yes Response,C66742,12,SDTMIG v3.3,PR,,,,,Y,C49488,,,,,,
ROUTE,PRROUTE,Route of Administration Response,C66729,13,SDTMIG v3.3,PR,,,,,,,,,,,,
STENRF,PRSTRTPT,Relation to Reference Period,C66728,14,SDTM v1.7,PR,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
BRDGMOOD,PRMOOD,BRIDG Activity Mood,C125923,15,SDTM v1.7,PR,,,,,,,,,,,,
STENRF,PRENRF,Relation to Reference Period,C66728,16,SDTM v1.7,PR,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,PRSTRF,Relation to Reference Period,C66728,17,SDTM v1.7,PR,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
ND,PRSTAT,Not Done,C66789,18,SDTM v1.7,PR,,,,,,,,,,,,
NY,PRFAST,No Yes Response,C66742,19,SDTM v1.7,PR,,,,,N; Y; U,C49487; C49488; C17998,,,,,,
UNIT,PRPSTRGU,Unit,C71620,20,SDTM v1.7,PR,,,,,,,,,,,,
EPOCH,EPOCH,Epoch,C99079,21,SDTMIG v3.3,PR,,,,,,,,,,,,
UNIT,PRVAMTU,Unit,C71620,22,SDTM v1.7,PR,,,,,,,,,,,,
SETTING,SUPPPR.QVAL,Environmental Setting,C127262,23,TAUG-PTSD v1.0,PR,,,,,,,SUPPPR.QNAM EQ "TSTSET",SUPPPR.QLABEL EQ "Setting of Test",,,,
TRTSET,SUPPPR.QVAL,Treatment Setting,C124308,24,TAUG-BrCa v1.0; TAUG-PanCan v1.0,PR,,,,,,,SUPPPR.QNAM EQ "TRTSTT",SUPPPR.QLABEL EQ "Setting",,,,
TRTINTNT,SUPPPR.QVAL,Treatment Intent,C124307,25,TAUG-BrCa v1.0,PR,,,,,,,SUPPPR.QNAM EQ "TRTINT",SUPPPR.QLABEL EQ "Treatment Intent",,,,
,SUPPPR.QVAL,,,26,TAUG-TBI v1.0,PR,ICD-9 Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who.int/classifications/icd/en/",World Health Organization (WHO),International Statistical Classification of Diseases and Related Health Problems 9th Revision (ICD-9),,,SUPPPR.QNAM EQ "DECDCD",SUPPPR.QLABEL EQ "Decode Code",,,,
,SUPPPR.QVAL,,,27,TAUG-TBI v1.0,PR,ICD-10 Code,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who.int/classifications/icd/en/",World Health Organization (WHO),International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10),,,SUPPPR.QNAM EQ "DECDCD",SUPPPR.QLABEL EQ "Decode Code",,,,
PRURGNCY,SUPPPR.QVAL,Procedure Urgency Status,C101856,28,TAUG-HIV v1.0,PR,,,,,,,SUPPPR.QNAM EQ "URGNCY",SUPPPR.QLABEL EQ "Procedure Urgency Status Type",,,,
LOC,SUPPPR.QVAL,Anatomical Location,C74456,29,TAUG-LuCa v1.0,PR,,,,,,,SUPPPR.QNAM EQ "PRLOC1",SUPPPR.QLABEL EQ "Location of Procedure 1",,,,
LOC,SUPPPR.QVAL,Anatomical Location,C74456,30,TAUG-LuCa v1.0,PR,,,,,,,SUPPPR.QNAM EQ "PRLOC2",SUPPPR.QLABEL EQ "Location of Procedure 2",,,,
SETTING,SUPPPR.QVAL,Environmental Setting,C127262,31,TAUG-T1D-ENM v1.0,PR,,,,,,,SUPPPR.QNAM EQ "SETTING",SUPPPR.QLABEL EQ "Environmental Setting",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SU,,,,,SU,C49615,,,,,,
,SUDECOD,,,2,SDTMIG v3.3,SU,WHODrug drug name,"Not required for regulatory submissions. Terminology is available in external dictionary. May not be used for most values in SU. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
,SUDECOD,,,3,SDTMIG v3.3,SU,WHODrug drug name,"Not required for regulatory submissions. Terminology is available in external dictionary. May not be used for most values in SU. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Dictionary,,,,,,,,
,SUCLAS,,,4,SDTMIG v3.3,SU,Anatomical Therapeutic Chemical Classification (ATC),"Not required for regulatory submissions. Terminology is available in external dictionary. May not be used for most values in SU. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
,SUCLAS,,,5,SDTMIG v3.3,SU,Anatomical Therapeutic Chemical Classification (ATC),"Not required for regulatory submissions. Terminology is available in external dictionary. May not be used for most values in SU. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Dictionary,,,,,,,,
,SUCLASCD,,,6,SDTMIG v3.3,SU,Anatomical Therapeutic Chemical Classification Code (ATCCD),"Not required for regulatory submissions. Terminology is available in external dictionary. May not be used for most values in SU. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
,SUCLASCD,,,7,SDTMIG v3.3,SU,Anatomical Therapeutic Chemical Classification Code (ATCCD),"Not required for regulatory submissions. Terminology is available in external dictionary. May not be used for most values in SU. \n Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/",Uppsala Monitoring Centre,WHODrug Global,,,,,,,,
NY,SUPRESP,No Yes Response,C66742,8,SDTMIG v3.3,SU,,,,,Y,C49488,,,,,,
NY,SUOCCUR,No Yes Response,C66742,9,SDTMIG v3.3,SU,,,,,N; Y,C49487; C49488,,,,,,
ND,SUSTAT,Not Done,C66789,10,SDTMIG v3.3,SU,,,,,,,,,,,,
UNIT,SUDOSU,Unit,C71620,11,SDTMIG v3.3,SU,,,,,,,,,,,,
FRM,SUDOSFRM,Pharmaceutical Dosage Form,C66726,12,SDTMIG v3.3,SU,,,,,,,,,,,,
FREQ,SUDOSFRQ,Frequency,C71113,13,SDTMIG v3.3,SU,,,,,,,,,,,,
ROUTE,SUROUTE,Route of Administration Response,C66729,14,SDTMIG v3.3,SU,,,,,,,,,,,,
STENRF,SUENRTPT,Relation to Reference Period,C66728,15,SDTMIG v3.3,SU,,,,,AFTER; BEFORE; COINCIDENT; ONGOING; UNKNOWN,C38008; C25629; C25456; C53279; C17998,,,,,,
STENRF,SUSTRTPT,Relation to Reference Period,C66728,16,SDTMIG v3.3,SU,,,,,AFTER; BEFORE; COINCIDENT; UNKNOWN,C38008; C25629; C25456; C17998,,,,,,
STENRF,SUENRF,Relation to Reference Period,C66728,17,SDTMIG v3.3,SU,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
STENRF,SUSTRF,Relation to Reference Period,C66728,18,SDTMIG v3.3,SU,,,,,AFTER; BEFORE; DURING; DURING/AFTER; UNKNOWN,C38008; C25629; C25490; C49640; C17998,,,,,,
EPOCH,EPOCH,Epoch,C99079,19,SDTMIG v3.3,SU,,,,,,,,,,,,
RELSUB,SREL,Relationship to Subject,C100130,1,SDTM v1.7,APRELSUB,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DR,,,,,DR,C102620,,,,,,
DOMAIN,RDOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,RELREC,,,,,,,,,,,,
RELTYPE,RELTYPE,Relationship Type,C78737,2,SDTMIG v3.3,RELREC,,,,,,,,,,,,
RELSUB,SREL,Relationship to Subject,C100130,1,SDTMIG v3.3,RELSUB,,,,,,,,,,,,
DOMAIN,RDOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SUPPQUAL,,,,,,,,,,,,
EVAL,QEVAL,Evaluator,C78735,2,SDTMIG v3.3,SUPPQUAL,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,CO,,,,,CO,C49569,,,,,,
DOMAIN,RDOMAIN,SDTM Domain Abbreviation,C66734,2,SDTMIG v3.3,CO,,,,,,,,,,,,
EVAL,COEVAL,Evaluator,C78735,3,SDTMIG v3.3,CO,,,,,,,,,,,,
MEDEVAL,COEVALID,Medical Evaluator,C96777,4,SDTMIG v3.3,CO,,,,,,,,,,,,
,ACTARM,,,1,SDTMIG v3.3,DM,,"With the exception of studies which use multi-stage Arm assignments, ACTARM must be a value of ARM in the Trial Arms Dataset.",,,,,,,,,,
,ACTARMCD,,,2,SDTMIG v3.3,DM,,"With the exception of studies which use multi-stage Arm assignments, ACTARMCD must be a value of ARMCD in the Trial Arms Dataset.",,,,,,,,,,
AGEU,AGEU,Age Unit,C66781,3,SDTMIG v3.3,DM,,,,,,,,,,,,
,ARM,,,4,SDTMIG v3.3,DM,,Value should correspond to TA.ARM (Source: SDTMIG v3.3. Section 5. DM Assumption 4.).,,,,,,,,,,
,ARMCD,,,5,SDTMIG v3.3,DM,,Value should correspond to TA.ARMCD (Source: SDTMIG v3.3. Section 5. DM Assumptions 4.).,,,,,,,,,,
,COUNTRY,,,6,SDTMIG v3.3,DM,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2020-10-17: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,,,,,,
,COUNTRY,,,7,SDTMIG v3.3,DM,GENC Alpha 3,"Per US FDA Data standards catalog, GENC should be used for FDA submissions. US FDA has not set any expectations on usage about two or three character codes. Suggest to use 3 character codes. \n Link to general information about the cited external dictionary, accessed 2021-05-13: https://evs.nci.nih.gov/ftp1/GENC/About.html",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,8,SDTMIG v3.3,DM,,,,,DM,C49572,,,,,,
NY,DTHFL,No Yes Response,C66742,9,SDTMIG v3.3,DM,,,,,Y,C49488,,,,,,
ETHNIC,ETHNIC,Ethnic Group,C66790,10,SDTMIG v3.3,DM,,,,,,,,,,,,
,ETHNIC,,,11,SDTMIG v3.3,DM,,"Also allows ""MULTIPLE"". When ""MULTIPLE"" is used, a record of SUPPDM.QVAL WHERE QNAM = ""ETHNICn"" is expected. (Source: SDTMIG v3.3 Section 4.2.8.3; SDTMIG v3.3 Section 5 DM Assumption 6).",,,,,,,,,,
RACE,RACE,Race,C74457,12,SDTMIG v3.3,DM,,"Also allows ""OTHER"". When ""OTHER"" is used, a record of SUPPDM.QVAL WHERE QNAM = ""RACEOTH"" is expected. (Source: SDTMIG v3.3. Section 5 DM Assumption 6). \n 'OTHER' was officially added to the RACE codelist with SDTM Terminology 2022-09-30.",,,,,,,,,,
,RACE,,,13,SDTMIG v3.3,DM,,"Also allows ""MULTIPLE"". When ""MULTIPLE"" is used, a record of SUPPDM.QVAL WHERE QNAM = ""RACEn"" is expected. (Source: SDTMIG v3.3 Section 4.2.8.3; SDTMIG v3.3 Section 5 DM Assumption 6).",,,,,,,,,,
SEX,SEX,Sex,C66731,14,SDTMIG v3.3,DM,,,,,,,,,,,,
ARMNULRS,ARMNRS,Arm Null Reason,C142179,15,SDTMIG v3.3,DM,,,,,,,ARM EQ "",,,,,
ARMNULRS,ARMNRS,Arm Null Reason,C142179,16,SDTMIG v3.3,DM,,,,,,,ACTARM EQ "",,,,,
RACE,SUPPDM.QVAL,Race,C74457,17,SDTMIG v3.3,DM,,Source: SDTMIG v3.3. Section 5 DM Assumption 6,,,,,SUPPDM.QNAM EQ "RACEn",SUPPDM.QLABEL EQ "Race",,,,
RACEC,SUPPDM.QVAL,Race As Collected,C128689,18,SDTMIG v3.3,DM,,,,,,,SUPPDM.QNAM EQ "RACEOR",SUPPDM.QLABEL EQ "Original Race",,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SE,,,,,SE,C49616,,,,,,
EPOCH,EPOCH,Epoch,C99079,2,SDTMIG v3.3,SE,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SM,,,,,SM,C147184,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,SV,,,,,SV,C49617,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG-MD v1.1,DI,,,,,DI,C102618,,,,text,,
DIPARMCD,DIPARMCD,Device Identifier Short Name,C106481,2,SDTMIG-MD v1.1,DI,,,,,,,,,,text,,
DIPARM,DIPARM,Device Identifier Long Name,C106480,3,SDTMIG-MD v1.1,DI,,,,,,,,,,text,,
,DIVAL,,,4,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "BATCH",DIPARM EQ "Batch Number",C104504,text,C104504,
,DIVAL,,,5,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "CATNUM",DIPARM EQ "Catalog Number",C99286,text,C99286,
,DIVAL,,,6,SDTMIG-MD v1.1,DI,Product Code,"Link to general information about the cited external dictionary, accessed 2020-06-16: https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database",U.S. Food and Drug Administration (US FDA),Product Code Classification Database,,,DIPARMCD EQ "DEVTYPE",DIPARM EQ "Device Type",C53265,text,C53265,
,DIVAL,,,7,SDTMIG-MD v1.1,DI,GMDN Term Code,"Link to general information about the cited external dictionary, accessed 2022-06-16: https://www.gmdnagency.org/assets/about/resources/GMDN Agency Terms Data Export Field Descriptions 2021-06-04.pdf",GMDN Agency,Global Medical Device Nomenclature (GMDN),,,DIPARMCD EQ "DEVTYPE",DIPARM EQ "Device Type",C53265,text,C53265,
,DIVAL,,,8,SDTMIG-MD v1.1,DI,Unique Device Identifier (UDI),"Link to general information about the cited external dictionary, accessed 2022-06-16: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid",U.S. Food and Drug Administration's Center for Devices and Radiological Health (US FDA CDRH),Global Unique Device Identification Database (GUDID),,,DIPARMCD EQ "FDAUDI",DIPARM EQ "FDA Unique Device Identification",C112279,text,C112279,
,DIVAL,,,9,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "LOT",DIPARM EQ "Lot Number",C70848,text,C70848,
,DIVAL,,,10,SDTMIG-MD v1.1,DI,D-U-N-S Number,"Link to general information about the cited external dictionary, accessed 2022-06-16: https://www.dnb.com/duns-number.html",Dun & Bradstreet,Data Universal Numbering System (DUNS),,,DIPARMCD EQ "MANUF",DIPARM EQ "Manufacturer",C25392,text,C25392,
,DIVAL,,,11,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "MODEL",DIPARM EQ "Model Number",C99285,text,C99285,
,DIVAL,,,12,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "SECURLD",DIPARM EQ "Secure Lead Type",C111191,text,C111191,
,DIVAL,,,13,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "SERIAL",DIPARM EQ "Serial Number",C73518,text,C73518,
,DIVAL,,,14,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "SPDEVDSC",DIPARM EQ "Sponsor Device Description",C106570,text,C106570,
,DIVAL,,,15,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "SFMTYP",DIPARM EQ "Stereotactic Surgery Frame Type",C170568,text,C170568,
,DIVAL,,,16,SDTMIG-MD v1.1,DI,,,,,,,DIPARMCD EQ "TRADENAM",DIPARM EQ "Trade Name",C71898,text,C71898,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,OI,,,,,OI,C161329,,,,text,,
OIPRMCD,OIPARMCD,Non-host Organism Identifier Parameters Code,C179591,2,SDTMIG v3.3,OI,,,,,,,,,,text,,
OIPRM,OIPARM,Non-host Organism Identifier Parameters,C179590,3,SDTMIG v3.3,OI,,,,,,,,,,text,,
,OIVAL,,,4,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "CLADE",OIPARM EQ "Clade",C179767,text,C179767,
,OIVAL,,,5,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "GENOTYPE",OIPARM EQ "Genotype",C179768,text,C179768,
,OIVAL,,,6,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "GEOORIG",OIPARM EQ "Geographical Origin",C179769,text,C179769,
,OIVAL,,,7,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "GROUP",OIPARM EQ "Group",C179770,text,C179770,
,OIVAL,,,8,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "ISOLATE",OIPARM EQ "Isolate",C179771,text,C179771,
,OIVAL,,,9,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "LINEAGE",OIPARM EQ "Lineage",C179772,text,C179772,
,OIVAL,,,10,SDTMIG v3.3,OI,Accession Number,"Link to general information about the cited external dictionary, accessed 2022-10-06: https://www.ncbi.nlm.nih.gov/genbank/",U.S. National Library of Medicine (US NLM),NCBI-GenBank,,,OIPARMCD EQ "NCBIGBID",OIPARM EQ "NCBI GenBank ID",C43685,text,C43685,
,OIVAL,,,11,SDTMIG v3.3,OI,Taxonomy ID,"Link to general information about the cited external dictionary, accessed 2022-10-06: https://www.ncbi.nlm.nih.gov/taxonomy",U.S. National Library of Medicine (US NLM),NCBI-Taxonomy,,,OIPARMCD EQ "NCBITXID",OIPARM EQ "NCBI Taxonomy ID",C179773,integer,C179773,
,OIVAL,,,12,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "PSDOBACK",OIPARM EQ "Pseudotype Viral Backbone",C179774,text,C179774,
MICROORG,OIVAL,Microorganism,C85491,13,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "SPECIES",OIPARM EQ "Species",C45293,text,C45293,
,OIVAL,,,14,SDTMIG v3.3,OI,Taxonomy ID,"Link to general information about the cited external dictionary, accessed 2022-10-06: https://www.ncbi.nlm.nih.gov/taxonomy",U.S. National Library of Medicine (US NLM),NCBI-Taxonomy,,,OIPARMCD EQ "SPECIES",OIPARM EQ "Species",C45293,text,C45293,
,OIVAL,,,15,SDTMIG v3.3,OI,Species Name,"Link to general information about the cited external dictionary, accessed 2022-10-06: https://ictv.global/taxonomy",International Committee on Taxonomy of Viruses,ICTV Taxonomy,,,OIPARMCD EQ "SPECIES",OIPARM EQ "Species",C45293,text,C45293,
,OIVAL,,,16,SDTMIG v3.3,OI,Taxonomy ID,"Link to general information about the cited external dictionary, accessed 2022-10-06: https://www.ncbi.nlm.nih.gov/taxonomy",U.S. National Library of Medicine (US NLM),NCBI-Taxonomy,,,OIPARMCD EQ "STRAIN",OIPARM EQ "Strain",C14419,text,C14419,
,OIVAL,,,17,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "SUBTYPE",OIPARM EQ "Subtype",C179775,text,C179775,
,OIVAL,,,18,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "TYPE",OIPARM EQ "Type",C179776,text,C179776,
,OIVAL,,,19,SDTMIG v3.3,OI,,,,,,,OIPARMCD EQ "YEARCOLL",OIPARM EQ "Year of Collection",C179777,integer,C179777,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TA,,,,,TA,C49618,,,,,,
EPOCH,EPOCH,Epoch,C99079,2,SDTMIG v3.3,TA,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TD,,,,,TD,C117699,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TE,,,,,TE,C49619,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TI,,,,,TI,C49620,,,,,,
IECAT,IECAT,Category for Inclusion/Exclusion,C66797,2,SDTMIG v3.3,TI,,,,,,,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TM,,,,,TM,C147270,,,,,,
NY,TMRPT,No Yes Response,C66742,2,SDTMIG v3.3,TM,,,,,N; Y,C49487; C49488,,,,,,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TS,,,,,TS,C53483,,,,text,,
TSPARMCD,TSPARMCD,Trial Summary Parameter Test Code,C66738,2,SDTMIG v3.3,TS,,,,,,,,,,text,,
TSPARM,TSPARM,Trial Summary Parameter Test Name,C67152,3,SDTMIG v3.3,TS,,,,,,,,,,text,,
,TSVALNF,,,4,SDTMIG v3.3,TS,ISO 21090 NullFlavor enumeration,"Link to general information about the cited external dictionary, accessed 2023-02-09 (Note: contains version specific information): https://www.iso.org/standard/35646.html",International Organization for Standardization (ISO),Health informatics - Harmonized data types for information interchange (ISO 21090),,,,,,text,,
DICTNAM,TSVCDREF,Dictionary Name,C66788,5,SDTMIG v3.3,TS,,,,,,,,,,text,,
NY,TSVAL,No Yes Response,C66742,6,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "ADAPT",TSPARM EQ "Adaptive Design",C146995,text,C146995,
NY,TSVAL,No Yes Response,C66742,7,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "ADDON",TSPARM EQ "Added on to Existing Treatments",C49703,text,C49703,
OBSSBSR,TSVAL,Observational Study Biospecimen Retention,C127258,8,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "BIOSPRET",TSPARM EQ "Biospecimen Retention Contains DNA",C126058,text,C126058,
,TSVAL,,,9,SDTMIG v3.3,TS,Preferred substance name,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "COMPTRT",TSPARM EQ "Comparative Treatment Name",C68612,text,C68612,US FDA; Japan PMDA
,TSVALCD,,,10,SDTMIG v3.3,TS,Unique Ingredient Identifier (UNII),"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "COMPTRT",TSPARM EQ "Comparative Treatment Name",C68612,text,C68612,US FDA; Japan PMDA
,TSVAL,,,11,SDTMIG v3.3,TS,Preferred substance name,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "CURTRT",TSPARM EQ "Current Therapy or Treatment",C85582,text,C85582,US FDA; Japan PMDA
,TSVALCD,,,12,SDTMIG v3.3,TS,Unique Ingredient Identifier (UNII),"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "CURTRT",TSPARM EQ "Current Therapy or Treatment",C85582,text,C85582,US FDA; Japan PMDA
CONROL,TSVAL,Contact Role for Clinical Study,C127257,13,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONROLE",TSPARM EQ "Contact Role",C176372,text,C176372,
CTAUGRS,TSVAL,CDISC Therapeutic Area User Guide Response,C160925,14,SDTMIG v3.3,TS,,"As per section 5.2 of the US FDA Study Data Technical Conformance Guide. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",,,,,TSPARMCD EQ "CTAUG",TSPARM EQ "CDISC Therapeutic Area User Guide",C156602,text,C156602,US FDA
NY,TSVAL,No Yes Response,C66742,15,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "DMCIND",TSPARM EQ "Data Monitoring Committee Indicator",C127790,text,C127790,
FREQ,TSVAL,Frequency,C71113,16,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSFRQ",TSPARM EQ "Dosing Frequency",C89081,text,C89081,
UNIT,TSVAL,Unit,C71620,17,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSU",TSPARM EQ "Dose Units",C73558,text,C73558,
NY,TSVAL,No Yes Response,C66742,18,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EGBLIND",TSPARM EQ "ECG Reading Blinded",C119560,text,C119560,
NY,TSVAL,No Yes Response,C66742,19,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EGCTMON",TSPARM EQ "ECG Continuous Monitoring",C119561,text,C119561,
EGLEAD,TSVAL,ECG Lead,C90013,20,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EGLEADPR",TSPARM EQ "ECG Planned Primary Lead",C119562,text,C119562,
NY,TSVAL,No Yes Response,C66742,21,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EGLEADSM",TSPARM EQ "ECG Used Same Lead",C119563,text,C119563,
EGRDMETH,TSVAL,ECG Read Method Response,C172333,22,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EGRDMETH",TSPARM EQ "ECG Read Method",C119564,text,C119564,
HEGRDMTH,TSVAL,Holter ECG Read Method Response,C184330,23,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EGRDMETH",TSPARM EQ "ECG Read Method",C119564,text,C119564,
NY,TSVAL,No Yes Response,C66742,24,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EGREPLBL",TSPARM EQ "ECG Replicates at Baseline",C119565,text,C119565,
NY,TSVAL,No Yes Response,C66742,25,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EGREPLTR",TSPARM EQ "ECG Replicates On-Treatment",C119566,text,C119566,
NY,TSVAL,No Yes Response,C66742,26,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EURSBIND",TSPARM EQ "EudraCT Resubmission Indicator",C126060,text,C126060,
NY,TSVAL,No Yes Response,C66742,27,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EXTTIND",TSPARM EQ "Extension Trial Indicator",C139274,text,C139274,
,TSVAL,,,28,SDTMIG v3.3,TS,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,TSPARMCD EQ "FCNTRY",TSPARM EQ "Planned Country of Investigational Sites",C98770,text,C98770,
,TSVAL,,,29,SDTMIG v3.3,TS,GENC Alpha 3,"Cited in US FDA Data Standards Catalog. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,TSPARMCD EQ "FCNTRY",TSPARM EQ "Planned Country of Investigational Sites",C98770,text,C98770,US FDA
NY,TSVAL,No Yes Response,C66742,30,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "FDADEIND",TSPARM EQ "FDA-Regulated Device Study Indicator",C123629,text,C123629,
NY,TSVAL,No Yes Response,C66742,31,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "FDADRIND",TSPARM EQ "FDA-Regulated Drug Study Indicator",C123630,text,C123630,
FDATSRS,TSVAL,FDA Technical Specification Response,C160926,32,SDTMIG v3.3,TS,,"Should be the exact listing on the study data standards resources website for technical specification documents. Ex. Vaccines Technical Specification Guidance v1.0. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources",,,,,TSPARMCD EQ "FDATCHSP",TSPARM EQ "FDA Technical Specification",C156603,text,C156603,
NY,TSVAL,No Yes Response,C66742,33,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "HLTSUBJI",TSPARM EQ "Healthy Subject Indicator",C98737,text,C98737,
,TSVAL,,,34,SDTMIG v3.3,TS,SNOMED CT Fully Specified Name,"Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "INDIC",TSPARM EQ "Trial Disease/Condition Indication",C112038,text,C112038,US FDA
,TSVALCD,,,35,SDTMIG v3.3,TS,SNOMED CT Identifier (SCTID),"Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "INDIC",TSPARM EQ "Trial Disease/Condition Indication",C112038,text,C112038,US FDA
INTMODEL,TSVAL,Intervention Model Response,C99076,36,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "INTMODEL",TSPARM EQ "Intervention Model",C98746,text,C98746,
INTTYPE,TSVAL,Intervention Type Response,C99078,37,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "INTTYPE",TSPARM EQ "Intervention Type",C98747,text,C98747,
,TSVAL,,,38,SDTMIG v3.3,TS,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.iso.org/iso-3166-country-codes.html",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,TSPARMCD EQ "MNFCNTRY",TSPARM EQ "Country of Manufacture",C124455,text,C124455,
,TSVAL,,,39,SDTMIG v3.3,TS,GENC Alpha 3,"Cited in FDA Study Data Catalog. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,TSPARMCD EQ "MNFCNTRY",TSPARM EQ "Country of Manufacture",C124455,text,C124455,US FDA
NY,TSVAL,No Yes Response,C66742,40,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "MSEUTIND",TSPARM EQ "Multiple Site EU State Trial Indicator",C127794,text,C127794,
OBSSMO,TSVAL,Observational Study Model,C127259,41,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSMODEL",TSPARM EQ "Observational Model",C126064,text,C126064,
OBSSTP,TSVAL,Observational Study Time Perspective,C127261,42,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSTIMP",TSPARM EQ "Observational Time Perspective",C126065,text,C126065,
OBSSSM,TSVAL,Observational Study Sampling Method,C127260,43,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSTSMM",TSPARM EQ "Observational Study Sampling Method",C126067,text,C126067,
NY,TSVAL,No Yes Response,C66742,44,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "PASSIND",TSPARM EQ "Post Authorization Safety Study Ind",C139275,text,C139275,
,TSVAL,,,45,SDTMIG v3.3,TS,Established pharmacologic class (EPC),"Refer to citation in US FDA Technical Conformance Guide. If the established pharmacologic class (EPC) is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. \n Link to general information about the cited external dictionary: https://evs.nci.nih.gov/ftp1/MED-RT/","Department of Veterans Affairs, Structured Product Labeling Interagency Expert Panel (SPLIEP)",Medication Reference Terminology (MED-RT),,,TSPARMCD EQ "PCLAS",TSPARM EQ "Pharmacologic Class",C98768,text,C98768,US FDA; Japan PMDA
,TSVALCD,,,46,SDTMIG v3.3,TS,Alphanumeric unique identifier (NUI),Link to general information about the cited external dictionary: https://evs.nci.nih.gov/ftp1/MED-RT/,"Department of Veterans Affairs, Structured Product Labeling Interagency Expert Panel (SPLIEP)",Medication Reference Terminology (MED-RT),,,TSPARMCD EQ "PCLAS",TSPARM EQ "Pharmacologic Class",C98768,text,C98768,US FDA; Japan PMDA
NY,TSVAL,No Yes Response,C66742,47,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "PDPSTIND",TSPARM EQ "Pediatric Postmarket Study Indicator",C123631,text,C123631,
NY,TSVAL,No Yes Response,C66742,48,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "PDSTIND",TSPARM EQ "Pediatric Study Indicator",C123632,text,C123632,
NY,TSVAL,No Yes Response,C66742,49,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "PIPIND",TSPARM EQ "Pediatric Investigation Plan Indicator",C126069,text,C126069,
RSKASMT,TSVAL,Risk Assessment,C101848,50,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PROTRSK",TSPARM EQ "Protocol Risk Assessment",C139277,text,C139277,
NY,TSVAL,No Yes Response,C66742,51,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "RANDOM",TSPARM EQ "Trial is Randomized",C25196,text,C25196,
NY,TSVAL,No Yes Response,C66742,52,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "RDIND",TSPARM EQ "Rare Disease Indicator",C126070,text,C126070,
,TSVAL,,,53,SDTMIG v3.3,TS,ClinicalTrials.gov Identifier,"US FDA Technical Conformance Guide. Appendix B: Trial Summary (TS) Parameters for Submission - Clinical. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources \n Link to general information about the cited external dictionary, accessed 2023-01-19: https://clinicaltrials.gov/",U.S. National Library of Medicine (US NLM),ClinicalTrials.gov,,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,text,C98714,US FDA
,TSVAL,,,54,SDTMIG v3.3,TS,EudraCT Number,"Link to general information about the cited external dictionary, accessed 2023-01-19: https://eudract.ema.europa.eu/",European Medicines Agency (EMA),European Union Drug Regulating Authorities Clinical Trials Database (EudraCT),,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,text,C98714,EMA
,TSVAL,,,55,SDTMIG v3.3,TS,JapicCTI-No,"Japan PMDA FAQs on Electronic Study Data Submission. https://www.pmda.go.jp/english/review-services/reviews/0002.html \n Link to general information about the cited external dictionary, accessed 2023-01-19: https://www.clinicaltrials.jp/",Japan Pharmaceutical Information Center (JAPIC),Japic Clinical Trials Information (JapicCTI),,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,text,C98714,Japan PMDA
ROUTE,TSVAL,Route of Administration Response,C66729,56,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "ROUTE",TSPARM EQ "Route of Administration",C38114,text,C38114,
NY,TSVAL,No Yes Response,C66742,57,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "RXMLCIND",TSPARM EQ "Request for XML Copy of Study Indicator",C127798,text,C127798,
SDTMIGRS,TSVAL,SDTM IG Version Response,C160924,58,SDTMIG v3.3,TS,,"The value should be the exact term listed in the US FDA Data Standards Catalog in tab 'Submission Data Exchange Stds', Column F. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",,,,,TSPARMCD EQ "SDTIGVER",TSPARM EQ "SDTM IG Version",C156604,text,C156604,US FDA
SDTMVRS,TSVAL,SDTM Version Response,C160923,59,SDTMIG v3.3,TS,,"The value should be the exact term \n listed in the US FDA Data Standards Catalog in tab 'Submission Data Exchange Stds', Column E. Link to US FDA Study Data Standard Resources, accessed 2023-02-09:: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",,,,,TSPARMCD EQ "SDTMVER",TSPARM EQ "SDTM Version",C156605,text,C156605,US FDA
NY,TSVAL,No Yes Response,C66742,60,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "SDXMLIND",TSPARM EQ "Secure Delivery XML Required Indicator",C127799,text,C127799,
SEXPOP,TSVAL,Sex of Participants Response,C66732,61,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SEXPOP",TSPARM EQ "Sex of Participants",C49696,text,C49696,
,TSVAL,,,62,SDTMIG v3.3,TS,Legal Business Name,"Use the DUNS Legal Business Name associated with the company address in the protocol for the study. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.dnb.com/duns-number.html",Dun & Bradstreet,Data Universal Numbering System (DUNS),,,TSPARMCD EQ "SPONSOR",TSPARM EQ "Clinical Study Sponsor",C70793,text,C70793,US FDA; Japan PMDA
,TSVALCD,,,63,SDTMIG v3.3,TS,D-U-N-S Number,"Use the DUNS number associated with the company address in the protocol for the study. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.dnb.com/duns-number.html",Dun & Bradstreet,Data Universal Numbering System (DUNS),,,TSPARMCD EQ "SPONSOR",TSPARM EQ "Clinical Study Sponsor",C70793,text,C70793,US FDA; Japan PMDA
NY,TSVAL,No Yes Response,C66742,64,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "SREVIND",TSPARM EQ "SUSAR Reporting to EVCTM Indicator",C126073,text,C126073,
NY,TSVAL,No Yes Response,C66742,65,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "SRNCAIND",TSPARM EQ "SUSAR Reporting to NCA Indicator",C126074,text,C126074,
NY,TSVAL,No Yes Response,C66742,66,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "SSEUTIND",TSPARM EQ "Single Site EU State Trial Indicator",C127800,text,C127800,
NY,TSVAL,No Yes Response,C66742,67,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "SSTDYIND",TSPARM EQ "Substudy Planned Indicator",C126076,text,C126076,
STYPE,TSVAL,Study Type Response,C99077,68,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "STYPE",TSPARM EQ "Study Type",C142175,text,C142175,
TBLIND,TSVAL,Trial Blinding Schema Response,C66735,69,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TBLIND",TSPARM EQ "Trial Blinding Schema",C49658,text,C49658,
TCNTRL,TSVAL,Control Type Response,C66785,70,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TCNTRL",TSPARM EQ "Control Type",C49647,text,C49647,
,TSVAL,,,71,SDTMIG v3.3,TS,SNOMED CT Fully Specified Name,"Appendix C of SDTMIG says 'SNOMED CT'. See US FDA Technical Conformance Guide section 6.6.1.1: Says to use SNOMED. \n Also see Notes in Appendix C of SDTMIG. 'If the study population is healthy subjects (i.e., healthy \n subjects flag is Y), this parameter is not expected.' \n Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,US FDA
,TSVALCD,,,72,SDTMIG v3.3,TS,SNOMED CT Identifier (SCTID),"Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,US FDA
,TSVAL,,,73,SDTMIG v3.3,TS,SNOMED CT Fully Specified Name,"Per Japan PMDA RULE IDs SD2267 and SD2268: SNOMED's concept ID is expected in TSVAL when it is not null for TSPARMCD EQ ""TDIGRP"" \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,Japan PMDA
,TSVALCD,,,74,SDTMIG v3.3,TS,SNOMED CT Identifier (SCTID),"Per Japan PMDA RULE IDs SD2267 and SD2268: SNOMED's concept ID is expected in TSVAL when it is not null for TSPARMCD EQ ""TDIGRP"" \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,Japan PMDA
TINDTP,TSVAL,Trial Intent Type Response,C66736,75,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TINDTP",TSPARM EQ "Trial Intent Type",C49652,text,C49652,
TPHASE,TSVAL,Trial Phase Response,C66737,76,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TPHASE",TSPARM EQ "Trial Phase Classification",C48281,text,C48281,
TTYPE,TSVAL,Trial Type Response,C66739,77,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TTYPE",TSPARM EQ "Trial Type",C49660,text,C49660,
,TSVAL,,,78,SDTMIG v3.3,TS,Preferred substance name,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "TRT",TSPARM EQ "Investigational Therapy or Treatment",C41161,text,C41161,US FDA; Japan PMDA
,TSVALCD,,,79,SDTMIG v3.3,TS,Unique Ingredient Identifier (UNII),"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "TRT",TSPARM EQ "Investigational Therapy or Treatment",C41161,text,C41161,US FDA; Japan PMDA
FRM,TSVAL,Pharmaceutical Dosage Form,C66726,80,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSFRM",TSPARM EQ "Dose Form",C42636,text,C42636,
NY,TSVAL,No Yes Response,C66742,81,SDTMIG v3.3,TS,,,,,N; Y,C49487; C49488,TSPARMCD EQ "EPDISIND",TSPARM EQ "Epi/Pandemic Related Disruption Ind",C171505,text,C171505,
,TSVAL,,,82,SDTMIG v3.3,TS,PubMed Identifier (PMID),,U.S. National Library of Medicine (US NLM),PubMed,,,TSPARMCD EQ "PUBMEDID",TSPARM EQ "PubMed ID for Citation Used in Study",C127797,text,C127797,
,TSVAL,,,83,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "ACTSUB",TSPARM EQ "Actual Number of Subjects",C98703,integer,C98703,
,TSVAL,,,84,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "AGEMAX",TSPARM EQ "Planned Maximum Age of Subjects",C49694,durationDatetime,C49694,
,TSVAL,,,85,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "AGEMIN",TSPARM EQ "Planned Minimum Age of Subjects",C49693,durationDatetime,C49693,
,TSVAL,,,86,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CITNSTDY",TSPARM EQ "Citation Used in Study",C127788,text,C127788,
,TSVAL,,,87,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CMSPSTAT",TSPARM EQ "Commercial Sponsor Status",C127789,text,C127789,
,TSVAL,,,88,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONEMAIL",TSPARM EQ "Contact E-Mail Address",C176375,text,C176375,
,TSVAL,,,89,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONMAIL",TSPARM EQ "Contact Mailing Address",C176376,text,C176376,
,TSVAL,,,90,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONNAME",TSPARM EQ "Contact Name",C176373,text,C176373,
,TSVAL,,,91,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONPHONE",TSPARM EQ "Contact Phone Number",C176374,text,C176374,
,TSVAL,,,92,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CRMDUR",TSPARM EQ "Confirmed Response Minimum Duration",C98715,durationDatetime,C98715,
,TSVAL,,,93,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CSRARDTC",TSPARM EQ "Clinical Study Report Archive Date",C139273,datetime,C139273,
,TSVAL,,,94,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DCUTDESC",TSPARM EQ "Data Cutoff Description",C98718,text,C98718,
,TSVAL,,,95,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DCUTDTC",TSPARM EQ "Data Cutoff Date",C98717,datetime,C98717,
,TSVAL,,,96,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DGFCRIT",TSPARM EQ "Delayed Graft Function Dx Criteria",C135514,text,C135514,
,TSVAL,,,97,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSE",TSPARM EQ "Dose per Administration",C25488,float,C25488,
,TSVAL,,,98,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSRGM",TSPARM EQ "Dose Regimen",C71137,text,C71137,
,TSVAL,,,99,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DXCRIT",TSPARM EQ "Diagnostic Criteria",C117960,text,C117960,
,TSVAL,,,100,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EGTWVALG",TSPARM EQ "ECG Twave Algorithm",C119582,text,C119582,
,TSVAL,,,101,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EMAILXML",TSPARM EQ "Email Address for XML File",C127791,text,C127791,
,TSVAL,,,102,SDTMIG v3.3,TS,EMA Decision number of Paediatric Investigation Plan,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000454-26/NL#A \n",European Medicines Agency (EMA),European Union Drug Regulating Authorities Clinical Trials Database (EudraCT),,,TSPARMCD EQ "EMPIPDCN",TSPARM EQ "EMA Decision Number for PIP",C126059,text,C126059,EMA
,TSVAL,,,103,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EPIDEMIC",TSPARM EQ "Name of Epi/Pandemic",C171506,text,C171506,
,TSVAL,,,104,SDTMIG v3.3,TS,Sender Identifier,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.ema.europa.eu/en/documents/other/detailed-guide-regarding-eudravigilance-data-management-activities-european-medicines-agency_en.pdf",European Medicines Agency (EMA),EudraVigilance,,,TSPARMCD EQ "EVSNDID",TSPARM EQ "EudraVigilance Sender ID",C126061,text,C126061,EMA
,TSVAL,,,105,SDTMIG v3.3,TS,Sender Organisation,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.ema.europa.eu/en/documents/other/detailed-guide-regarding-eudravigilance-data-management-activities-european-medicines-agency_en.pdf",European Medicines Agency (EMA),EudraVigilance,,,TSPARMCD EQ "EVSNDORG",TSPARM EQ "EudraVigilance Sender Organization",C126090,text,C126090,EMA
,TSVAL,,,106,SDTMIG v3.3,TS,Expanded Access Record NCT Number,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://prsinfo.clinicaltrials.gov/definitions.html",U.S. National Library of Medicine (US NLM),ClinicalTrials.gov,,,TSPARMCD EQ "EXPARECN",TSPARM EQ "Expanded Access Record NCT Number",C127792,text,C127792,
,TSVAL,,,107,SDTMIG v3.3,TS,Expanded Access Status,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://prsinfo.clinicaltrials.gov/expanded_access_definitions.html",U.S. National Library of Medicine (US NLM),ClinicalTrials.gov,,,TSPARMCD EQ "EXPASTAT",TSPARM EQ "Expanded Access Status",C127793,text,C127793,
,TSVAL,,,108,SDTMIG v3.3,TS,MeSH Term,"When the target trial registry is ClinicalTrials.gov, this parameter should contain MeSH terms, where appropriate. (https://prsinfo.clinicaltrials.gov/definitions.html) \n Link to general information about the cited external dictionary, accessed 2023-01-26: https://www.ncbi.nlm.nih.gov/mesh/",U.S. National Library of Medicine (US NLM),Medical Subject Headings (MeSH),,,TSPARMCD EQ "KEYWORD",TSPARM EQ "Protocol Keyword",C126062,text,C126062,
,TSVAL,,,109,SDTMIG v3.3,TS,,This parameter may contain free form text when the target trial registry is not ClinicalTrials.gov.,,,,,TSPARMCD EQ "KEYWORD",TSPARM EQ "Protocol Keyword",C126062,text,C126062,
,TSVAL,,,110,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "LENGTH",TSPARM EQ "Trial Length",C49697,durationDatetime,C49697,
,TSVAL,,,111,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "NARMS",TSPARM EQ "Planned Number of Arms",C98771,integer,C98771,
,TSVAL,,,112,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "NCOHORT",TSPARM EQ "Number of Groups/Cohorts",C126063,integer,C126063,
,TSVAL,,,113,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "NUMSEUST",TSPARM EQ "Number of Trial Sites EU State",C127795,integer,C127795,
,TSVAL,,,114,SDTMIG v3.3,TS,,"Section 7.4.2 of SDTMIGv3.3, Assumption 9: ""A protocol may use multiple designations for objectives that are not primary (e.g., Secondary, Tertiary, and Exploratory), but all these non-primary objectives should be given as values of TSPARM = ""OBJSEC"".""",,,,,TSPARMCD EQ "OBJEXP",TSPARM EQ "Trial Exploratory Objective",C163559,text,C163559,
,TSVAL,,,115,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBJPRIM",TSPARM EQ "Trial Primary Objective",C85826,text,C85826,
,TSVAL,,,116,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBJSEC",TSPARM EQ "Trial Secondary Objective",C85827,text,C85827,
,TSVAL,,,117,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSTPOPD",TSPARM EQ "Obs Study Population Description",C126066,text,C126066,
,TSVAL,,,118,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSTSMM",TSPARM EQ "Obs Study Sampling Method Description",C126068,text,C126068,
,TSVAL,,,119,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSADD",TSPARM EQ "Additional Outcome Measure",C156601,text,C156601,
,TSVAL,,,120,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSEXP",TSPARM EQ "Exploratory Outcome Measure",C98724,text,C98724,
,TSVAL,,,121,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSPRI",TSPARM EQ "Primary Outcome Measure",C98772,text,C98772,
,TSVAL,,,122,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSSEC",TSPARM EQ "Secondary Outcome Measure",C98781,text,C98781,
,TSVAL,,,123,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PLANSUB",TSPARM EQ "Planned Number of Subjects",C49692,integer,C49692,
,TSVAL,,,124,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PLNTRDUR",TSPARM EQ "Planned Trial Duration",C127796,durationDatetime,C127796,
,TSVAL,,,125,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PTRTDUR",TSPARM EQ "Planned Treatment Duration",C139276,durationDatetime,C139276,
,TSVAL,,,126,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RANDQT",TSPARM EQ "Randomization Quotient",C98775,float,C98775,
,TSVAL,,,127,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RESUBLTR",TSPARM EQ "Resubmission Letter",C126071,text,C126071,
,TSVAL,,,128,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RLPSCRIT",TSPARM EQ "Relapse Criteria",C117961,text,C117961,
,TSVAL,,,129,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RTSPCDES",TSPARM EQ "Retained Biospecimen Description",C126072,text,C126072,
,TSVAL,,,130,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SDMDUR",TSPARM EQ "Stable Disease Minimum Duration",C98783,durationDatetime,C98783,
,TSVAL,,,131,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SENDTC",TSPARM EQ "Study End Date",C90462,datetime,C90462,
,TSVAL,,,132,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SEVCRIT",TSPARM EQ "Severity Criteria",C117962,text,C117962,
,TSVAL,,,133,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SPREFID",TSPARM EQ "Sponsor's Study Reference ID",C135009,text,C135009,
,TSVAL,,,134,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SSTDTC",TSPARM EQ "Study Start Date",C69208,datetime,C69208,
,TSVAL,,,135,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SSTDYDTL",TSPARM EQ "Substudy Details",C126075,text,C126075,
,TSVAL,,,136,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "STOPRULE",TSPARM EQ "Study Stop Rules",C49698,text,C49698,
,TSVAL,,,137,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "STRATFCT",TSPARM EQ "Stratification Factor",C16153,text,C16153,
,TSVAL,,,138,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "THERAREA",TSPARM EQ "Therapeutic Area",C101302,text,C101302,
,TSVAL,,,139,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TITLE",TSPARM EQ "Trial Title",C49802,text,C49802,
,TSVAL,,,140,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TRGFUDUR",TSPARM EQ "Target Follow-Up Duration",C126077,durationDatetime,C126077,
,TSVAL,,,141,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "URLSTDY",TSPARM EQ "URL Related to Study",C127801,text,C127801,
,TSVAL,,,142,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "URLSTDYD",TSPARM EQ "URL Related to Study Description",C127802,text,C127802,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,TS,C53483,,,,text,,
TSPARMCD,TSPARMCD,Trial Summary Parameter Test Code,C66738,2,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,,,,text,,
TSPARM,TSPARM,Trial Summary Parameter Test Name,C67152,3,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,,,,text,,
,TSVALNF,,,4,SDTMIG v3.3,TS,ISO 21090 NullFlavor enumeration,"Link to general information about the cited external dictionary, accessed 2023-02-09 (Note: contains version specific information): https://www.iso.org/standard/35646.html",International Organization for Standardization (ISO),Health informatics - Harmonized data types for information interchange (ISO 21090),,,,,,text,,
DICTNAM,TSVCDREF,Dictionary Name,C66788,5,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,,,,text,,
NY,TSVAL,No Yes Response,C66742,6,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "ADAPT",TSPARM EQ "Adaptive Design",C146995,text,C146995,
NY,TSVAL,No Yes Response,C66742,7,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "ADDON",TSPARM EQ "Added on to Existing Treatments",C49703,text,C49703,
OBSSBSR,TSVAL,Observational Study Biospecimen Retention,C127258,8,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "BIOSPRET",TSPARM EQ "Biospecimen Retention Contains DNA",C126058,text,C126058,
,TSVAL,,,9,SDTMIG v3.3,TS,Preferred substance name,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "COMPTRT",TSPARM EQ "Comparative Treatment Name",C68612,text,C68612,US FDA; Japan PMDA
,TSVALCD,,,10,SDTMIG v3.3,TS,Unique Ingredient Identifier (UNII),"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "COMPTRT",TSPARM EQ "Comparative Treatment Name",C68612,text,C68612,US FDA; Japan PMDA
,TSVAL,,,11,SDTMIG v3.3,TS,Preferred substance name,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "CURTRT",TSPARM EQ "Current Therapy or Treatment",C85582,text,C85582,US FDA; Japan PMDA
,TSVALCD,,,12,SDTMIG v3.3,TS,Unique Ingredient Identifier (UNII),"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "CURTRT",TSPARM EQ "Current Therapy or Treatment",C85582,text,C85582,US FDA; Japan PMDA
CONROL,TSVAL,Contact Role for Clinical Study,C127257,13,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "CONROLE",TSPARM EQ "Contact Role",C176372,text,C176372,
CTAUGRS,TSVAL,CDISC Therapeutic Area User Guide Response,C160925,14,SDTMIG v3.3,TS,,"As per section 5.2 of the US FDA Study Data Technical Conformance Guide. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources \n Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.",,,,,TSPARMCD EQ "CTAUG",TSPARM EQ "CDISC Therapeutic Area User Guide",C156602,text,C156602,US FDA
NY,TSVAL,No Yes Response,C66742,15,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "DMCIND",TSPARM EQ "Data Monitoring Committee Indicator",C127790,text,C127790,
FREQ,TSVAL,Frequency,C71113,16,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "DOSFRQ",TSPARM EQ "Dosing Frequency",C89081,text,C89081,
UNIT,TSVAL,Unit,C71620,17,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "DOSU",TSPARM EQ "Dose Units",C73558,text,C73558,
NY,TSVAL,No Yes Response,C66742,18,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EGBLIND",TSPARM EQ "ECG Reading Blinded",C119560,text,C119560,
NY,TSVAL,No Yes Response,C66742,19,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EGCTMON",TSPARM EQ "ECG Continuous Monitoring",C119561,text,C119561,
EGLEAD,TSVAL,ECG Lead,C90013,20,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "EGLEADPR",TSPARM EQ "ECG Planned Primary Lead",C119562,text,C119562,
NY,TSVAL,No Yes Response,C66742,21,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EGLEADSM",TSPARM EQ "ECG Used Same Lead",C119563,text,C119563,
EGRDMETH,TSVAL,ECG Read Method Response,C172333,22,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "EGRDMETH",TSPARM EQ "ECG Read Method",C119564,text,C119564,
HEGRDMTH,TSVAL,Holter ECG Read Method Response,C184330,23,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "EGRDMETH",TSPARM EQ "ECG Read Method",C119564,text,C119564,
NY,TSVAL,No Yes Response,C66742,24,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EGREPLBL",TSPARM EQ "ECG Replicates at Baseline",C119565,text,C119565,
NY,TSVAL,No Yes Response,C66742,25,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EGREPLTR",TSPARM EQ "ECG Replicates On-Treatment",C119566,text,C119566,
NY,TSVAL,No Yes Response,C66742,26,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EURSBIND",TSPARM EQ "EudraCT Resubmission Indicator",C126060,text,C126060,
NY,TSVAL,No Yes Response,C66742,27,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EXTTIND",TSPARM EQ "Extension Trial Indicator",C139274,text,C139274,
,TSVAL,,,28,SDTMIG v3.3,TS,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.iso.org/iso-3166-country-codes.html \n According to rows 33-35 on pg 395 of the SDTMIG v3.3, TSVAL should be the English name, the Alpha 3 version goes to TSVALCD. It is important to note that's not the case in SDTMIG v3.4, TSVAL has the Alpha-3 value, while TSVALCD is left blank.",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,TSPARMCD EQ "FCNTRY",TSPARM EQ "Planned Country of Investigational Sites",C98770,text,C98770,
,TSVALCD,,,29,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "FCNTRY",TSPARM EQ "Planned Country of Investigational Sites",C98770,,C98770,
,TSVAL,,,30,SDTMIG v3.3,TS,GENC Alpha 3,"Cited in US FDA Data Standards Catalog. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,TSPARMCD EQ "FCNTRY",TSPARM EQ "Planned Country of Investigational Sites",C98770,text,C98770,US FDA
,TSVALCD,,,31,SDTMIG v3.3,TS,TBD,2022-02-20: Further investigation is needed - NCI EVS codes GENC. Both NCIt Concept Code and GENC Number are candidates for TSVALCD,National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,TSPARMCD EQ "FCNTRY",TSPARM EQ "Planned Country of Investigational Sites",C98770,text,C98770,US FDA
NY,TSVAL,No Yes Response,C66742,32,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "FDADEIND",TSPARM EQ "FDA-Regulated Device Study Indicator",C123629,text,C123629,
NY,TSVAL,No Yes Response,C66742,33,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "FDADRIND",TSPARM EQ "FDA-Regulated Drug Study Indicator",C123630,text,C123630,
FDATSRS,TSVAL,FDA Technical Specification Response,C160926,34,SDTMIG v3.3,TS,,"Should be the exact listing on the study data standards resources website for technical specification documents. Ex. Vaccines Technical Specification Guidance v1.0. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources \n Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.",,,,,TSPARMCD EQ "FDATCHSP",TSPARM EQ "FDA Technical Specification",C156603,text,C156603,
NY,TSVAL,No Yes Response,C66742,35,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "HLTSUBJI",TSPARM EQ "Healthy Subject Indicator",C98737,text,C98737,
,TSVAL,,,36,SDTMIG v3.3,TS,SNOMED CT Fully Specified Name,"Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "INDIC",TSPARM EQ "Trial Disease/Condition Indication",C112038,text,C112038,US FDA
,TSVALCD,,,37,SDTMIG v3.3,TS,SNOMED CT Identifier (SCTID),"Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "INDIC",TSPARM EQ "Trial Disease/Condition Indication",C112038,text,C112038,US FDA
INTMODEL,TSVAL,Intervention Model Response,C99076,38,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "INTMODEL",TSPARM EQ "Intervention Model",C98746,text,C98746,
INTTYPE,TSVAL,Intervention Type Response,C99078,39,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "INTTYPE",TSPARM EQ "Intervention Type",C98747,text,C98747,
,TSVAL,,,40,SDTMIG v3.3,TS,ISO 3166-1 Alpha-3,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.iso.org/iso-3166-country-codes.html \n According to rows 33-35 on pg 395 of the SDTMIG v3.3, TSVAL should be the English name, the Alpha 3 version goes to TSVALCD. It is important to note that's not the case in SDTMIG v3.4, TSVAL has the Alpha-3 value, while TSVALCD is left blank.",International Organization for Standardization (ISO),Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1),,,TSPARMCD EQ "MNFCNTRY",TSPARM EQ "Country of Manufacture",C124455,text,C124455,
,TSVAL,,,41,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "MNFCNTRY",TSPARM EQ "Country of Manufacture",C124455,,C124455,
,TSVAL,,,42,SDTMIG v3.3,TS,GENC Alpha 3,"Cited in FDA Study Data Catalog. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources",National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,TSPARMCD EQ "MNFCNTRY",TSPARM EQ "Country of Manufacture",C124455,text,C124455,US FDA
,TSVALCD,,,43,SDTMIG v3.3,TS,TBD,2022-02-20: Further investigation is needed - NCI EVS codes GENC. Both NCIt Concept Code and GENC Number are candidates for TSVALCD,National Geospatial-Intelligence Agency National Center for Geospatial Intelligence Standards (NGA NCGIS),"Geopolitical Entities, Names, and Codes (GENC)",,,TSPARMCD EQ "MNFCNTRY",TSPARM EQ "Country of Manufacture",C124455,text,C124455,US FDA
NY,TSVAL,No Yes Response,C66742,44,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "MSEUTIND",TSPARM EQ "Multiple Site EU State Trial Indicator",C127794,text,C127794,
OBSSMO,TSVAL,Observational Study Model,C127259,45,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "OBSMODEL",TSPARM EQ "Observational Model",C126064,text,C126064,
OBSSTP,TSVAL,Observational Study Time Perspective,C127261,46,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "OBSTIMP",TSPARM EQ "Observational Time Perspective",C126065,text,C126065,
OBSSSM,TSVAL,Observational Study Sampling Method,C127260,47,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "OBSTSMM",TSPARM EQ "Observational Study Sampling Method",C126067,text,C126067,
NY,TSVAL,No Yes Response,C66742,48,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "PASSIND",TSPARM EQ "Post Authorization Safety Study Ind",C139275,text,C139275,
,TSVAL,,,49,SDTMIG v3.3,TS,Established pharmacologic class (EPC),"Refer to citation in US FDA Technical Conformance Guide. If the established pharmacologic class (EPC) is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. \n Link to general information about the cited external dictionary: https://evs.nci.nih.gov/ftp1/MED-RT/","Department of Veterans Affairs, Structured Product Labeling Interagency Expert Panel (SPLIEP)",Medication Reference Terminology (MED-RT),,,TSPARMCD EQ "PCLAS",TSPARM EQ "Pharmacologic Class",C98768,text,C98768,US FDA; Japan PMDA
,TSVALCD,,,50,SDTMIG v3.3,TS,Alphanumeric unique identifier (NUI),Link to general information about the cited external dictionary: https://evs.nci.nih.gov/ftp1/MED-RT/,"Department of Veterans Affairs, Structured Product Labeling Interagency Expert Panel (SPLIEP)",Medication Reference Terminology (MED-RT),,,TSPARMCD EQ "PCLAS",TSPARM EQ "Pharmacologic Class",C98768,text,C98768,US FDA; Japan PMDA
NY,TSVAL,No Yes Response,C66742,51,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "PDPSTIND",TSPARM EQ "Pediatric Postmarket Study Indicator",C123631,text,C123631,
NY,TSVAL,No Yes Response,C66742,52,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "PDSTIND",TSPARM EQ "Pediatric Study Indicator",C123632,text,C123632,
NY,TSVAL,No Yes Response,C66742,53,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "PIPIND",TSPARM EQ "Pediatric Investigation Plan Indicator",C126069,text,C126069,
RSKASMT,TSVAL,Risk Assessment,C101848,54,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "PROTRSK",TSPARM EQ "Protocol Risk Assessment",C139277,text,C139277,
NY,TSVAL,No Yes Response,C66742,55,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "RANDOM",TSPARM EQ "Trial is Randomized",C25196,text,C25196,
NY,TSVAL,No Yes Response,C66742,56,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "RDIND",TSPARM EQ "Rare Disease Indicator",C126070,text,C126070,
,TSVAL,,,57,SDTMIG v3.3,TS,ClinicalTrials.gov Identifier,"US FDA Technical Conformance Guide. Appendix B: Trial Summary (TS) Parameters for Submission - Clinical. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources \n Link to general information about the cited external dictionary, accessed 2023-01-19: https://clinicaltrials.gov/ \n 2024-02-08: When TSVALCD is not used, annotate [null]; need to follow up whether it is appropriate to duplicate ""Registry Identifier"" from TSVAL to TSVALCD. \n AI: Send an email to SDS to confirm what's in v3.4 example is just a typo to duplicate the NCT number.",U.S. National Library of Medicine (US NLM),ClinicalTrials.gov,,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,text,C98714,US FDA
,TSVALCD,,,58,SDTMIG v3.3,TS,,"The example presented in row 26 demonstrates that TSVALCD duplicates TSVAL in SDTMIG version 3.3 on page 396, as well as in SDTMIG version 3.4 on page 420. This duplication is a typographical error. \n TSVALCD is not applicable and is set to null for this trial summary parameter.",,,,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,,C98714,
,TSVAL,,,59,SDTMIG v3.3,TS,EudraCT Number,"Link to general information about the cited external dictionary, accessed 2023-01-19: https://eudract.ema.europa.eu/ \n AI: Send an email to SDS to confirm what's in v3.4 example is just a typo to duplicate the NCT number.",European Medicines Agency (EMA),European Union Drug Regulating Authorities Clinical Trials Database (EudraCT),,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,text,C98714,EMA
,TSVALCD,,,60,SDTMIG v3.3,TS,,"The example presented in row 26 demonstrates that TSVALCD duplicates TSVAL in SDTMIG version 3.3 on page 396, as well as in SDTMIG version 3.4 on page 420. This duplication is a typographical error. \n TSVALCD is not applicable and is set to null for this trial summary parameter.",,,,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,,C98714,EMA
,TSVAL,,,61,SDTMIG v3.3,TS,Trial ID,"Japan PMDA FAQs on Electronic Study Data Submission. https://www.pmda.go.jp/english/review-services/reviews/0002.html \n Link to general information about the cited external dictionary, accessed 2024-04-08: https://jrct.niph.go.jp \n 2024-02-22: Contingent on our discussion w/ SDS re: ClinicalTrials.gov, we want to handle this the same way. We lean on N/A currently.",Japan National Institute of Public Health,Japan Registry of Clinical Trials (jRCT),,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,text,C98714,Japan PMDA
,TSVALCD,,,62,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "REGID",TSPARM EQ "Registry Identifier",C98714,,C98714,Japan PMDA
ROUTE,TSVAL,Route of Administration Response,C66729,63,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "ROUTE",TSPARM EQ "Route of Administration",C38114,text,C38114,
NY,TSVAL,No Yes Response,C66742,64,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "RXMLCIND",TSPARM EQ "Request for XML Copy of Study Indicator",C127798,text,C127798,
SDTMIGRS,TSVAL,SDTM IG Version Response,C160924,65,SDTMIG v3.3,TS,,"The value should be the exact term listed in the US FDA Data Standards Catalog in tab 'Submission Data Exchange Stds', Column F. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources \n Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.",,,,,TSPARMCD EQ "SDTIGVER",TSPARM EQ "SDTM IG Version",C156604,text,C156604,US FDA
SDTMVRS,TSVAL,SDTM Version Response,C160923,66,SDTMIG v3.3,TS,,"The value should be the exact term listed in the US FDA Data Standards Catalog in tab 'Submission Data Exchange Stds', Column E. Link to US FDA Study Data Standard Resources, accessed 2023-02-09: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources \n Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.",,,,,TSPARMCD EQ "SDTMVER",TSPARM EQ "SDTM Version",C156605,text,C156605,US FDA
NY,TSVAL,No Yes Response,C66742,67,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "SDXMLIND",TSPARM EQ "Secure Delivery XML Required Indicator",C127799,text,C127799,
SEXPOP,TSVAL,Sex of Participants Response,C66732,68,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "SEXPOP",TSPARM EQ "Sex of Participants",C49696,text,C49696,
,TSVAL,,,69,SDTMIG v3.3,TS,Legal Business Name,"Use the DUNS Legal Business Name associated with the company address in the protocol for the study. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.dnb.com/duns-number.html",Dun & Bradstreet,Data Universal Numbering System (DUNS),,,TSPARMCD EQ "SPONSOR",TSPARM EQ "Clinical Study Sponsor",C70793,text,C70793,US FDA; Japan PMDA
,TSVALCD,,,70,SDTMIG v3.3,TS,D-U-N-S Number,"Use the DUNS number associated with the company address in the protocol for the study. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.dnb.com/duns-number.html",Dun & Bradstreet,Data Universal Numbering System (DUNS),,,TSPARMCD EQ "SPONSOR",TSPARM EQ "Clinical Study Sponsor",C70793,text,C70793,US FDA; Japan PMDA
NY,TSVAL,No Yes Response,C66742,71,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "SREVIND",TSPARM EQ "SUSAR Reporting to EVCTM Indicator",C126073,text,C126073,
NY,TSVAL,No Yes Response,C66742,72,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "SRNCAIND",TSPARM EQ "SUSAR Reporting to NCA Indicator",C126074,text,C126074,
NY,TSVAL,No Yes Response,C66742,73,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "SSEUTIND",TSPARM EQ "Single Site EU State Trial Indicator",C127800,text,C127800,
NY,TSVAL,No Yes Response,C66742,74,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "SSTDYIND",TSPARM EQ "Substudy Planned Indicator",C126076,text,C126076,
STYPE,TSVAL,Study Type Response,C99077,75,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "STYPE",TSPARM EQ "Study Type",>C142175,text,C142175,
TBLIND,TSVAL,Trial Blinding Schema Response,C66735,76,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "TBLIND",TSPARM EQ "Trial Blinding Schema",C49658,text,C49658,
TCNTRL,TSVAL,Control Type Response,C66785,77,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "TCNTRL",TSPARM EQ "Control Type",C49647,text,C49647,
,TSVAL,,,78,SDTMIG v3.3,TS,SNOMED CT Fully Specified Name,"Appendix C of SDTMIG says 'SNOMED CT'. See US FDA Technical Conformance Guide section 6.6.1.1: Says to use SNOMED. \n Also see Notes in Appendix C of SDTMIG. 'If the study population is healthy subjects (i.e., healthy \n subjects flag is Y), this parameter is not expected.' \n Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,US FDA
,TSVALCD,,,79,SDTMIG v3.3,TS,SNOMED CT Identifier (SCTID),"Other dictionaries beside SNOMED CT may be used if the data is not being submitted to the US FDA. \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,US FDA
,TSVAL,,,80,SDTMIG v3.3,TS,SNOMED CT Fully Specified Name,"Per Japan PMDA RULE IDs SD2267 and SD2268: SNOMED's concept ID is expected in TSVAL when it is not null for TSPARMCD EQ ""TDIGRP"" \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,Japan PMDA
,TSVALCD,,,81,SDTMIG v3.3,TS,SNOMED CT Identifier (SCTID),"Per Japan PMDA RULE IDs SD2267 and SD2268: SNOMED's concept ID is expected in TSVAL when it is not null for TSPARMCD EQ ""TDIGRP"" \n Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.snomed.org/snomed-ct/",International Health Terminology Standards Organisation (IHTSDO),Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT),,,TSPARMCD EQ "TDIGRP",TSPARM EQ "Diagnosis Group",C49650,text,C49650,Japan PMDA
TINDTP,TSVAL,Trial Intent Type Response,C66736,82,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "TINDTP",TSPARM EQ "Trial Intent Type",C49652,text,C49652,
TPHASE,TSVAL,Trial Phase Response,C66737,83,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "TPHASE",TSPARM EQ "Trial Phase Classification",C48281,text,C48281,
TTYPE,TSVAL,Trial Type Response,C66739,84,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "TTYPE",TSPARM EQ "Trial Type",C49660,text,C49660,
,TSVAL,,,85,SDTMIG v3.3,TS,Preferred substance name,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "TRT",TSPARM EQ "Investigational Therapy or Treatment",C41161,text,C41161,US FDA; Japan PMDA
,TSVALCD,,,86,SDTMIG v3.3,TS,Unique Ingredient Identifier (UNII),"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.fda.gov/industry/fda-resources-data-standards/fdas-global-substance-registration-system/",U.S. Food and Drug Administration (US FDA),Global Substance Registration System (G-SRS),,,TSPARMCD EQ "TRT",TSPARM EQ "Investigational Therapy or Treatment",C41161,text,C41161,US FDA; Japan PMDA
FRM,TSVAL,Pharmaceutical Dosage Form,C66726,87,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "DOSFRM",TSPARM EQ "Dose Form",C42636,text,C42636,
NY,TSVAL,No Yes Response,C66742,88,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "EPDISIND",TSPARM EQ "Epi/Pandemic Related Disruption Ind",C171505,text,C171505,
,TSVAL,,,89,SDTMIG v3.3,TS,PubMed Identifier (PMID),"Link to general information about the cited external dictionary, accessed 2024-05-02: https://pubmed.ncbi.nlm.nih.gov/",U.S. National Library of Medicine (US NLM),PubMed,,,TSPARMCD EQ "PUBMEDID",TSPARM EQ "PubMed ID for Citation Used in Study",C127797,text,C127797,
,TSVALCD,,,90,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "PUBMEDID",TSPARM EQ "PubMed ID for Citation Used in Study",C127797,,C127797,
,TSVAL,,,91,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "ACTSUB",TSPARM EQ "Actual Number of Subjects",C98703,integer,C98703,
,TSVAL,,,92,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "AGEMAX",TSPARM EQ "Planned Maximum Age of Subjects",C49694,durationDatetime,C49694,
,TSVAL,,,93,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "AGEMIN",TSPARM EQ "Planned Minimum Age of Subjects",C49693,durationDatetime,C49693,
,TSVAL,,,94,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CITNSTDY",TSPARM EQ "Citation Used in Study",C127788,text,C127788,
CMSPSTAT,TSVAL,Commercial Sponsor Status Response,C187681,95,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "CMSPSTAT",TSPARM EQ "Commercial Sponsor Status",C127789,text,C127789,
,TSVAL,,,96,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONEMAIL",TSPARM EQ "Contact E-Mail Address",C176375,text,C176375,
,TSVAL,,,97,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONMAIL",TSPARM EQ "Contact Mailing Address",C176376,text,C176376,
,TSVAL,,,98,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONNAME",TSPARM EQ "Contact Name",C176373,text,C176373,
,TSVAL,,,99,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CONPHONE",TSPARM EQ "Contact Phone Number",C176374,text,C176374,
,TSVAL,,,100,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CRMDUR",TSPARM EQ "Confirmed Response Minimum Duration",C98715,durationDatetime,C98715,
,TSVAL,,,101,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "CSRARDTC",TSPARM EQ "Clinical Study Report Archive Date",C139273,datetime,C139273,
,TSVAL,,,102,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DCUTDESC",TSPARM EQ "Data Cutoff Description",C98718,text,C98718,
,TSVAL,,,103,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DCUTDTC",TSPARM EQ "Data Cutoff Date",C98717,datetime,C98717,
,TSVAL,,,104,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DGFCRIT",TSPARM EQ "Delayed Graft Function Dx Criteria",C135514,text,C135514,
,TSVAL,,,105,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSE",TSPARM EQ "Dose per Administration",C25488,float,C25488,
,TSVAL,,,106,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DOSRGM",TSPARM EQ "Dose Regimen",C71137,text,C71137,
,TSVAL,,,107,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "DXCRIT",TSPARM EQ "Diagnostic Criteria",C117960,text,C117960,
,TSVAL,,,108,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EGTWVALG",TSPARM EQ "ECG Twave Algorithm",C119582,text,C119582,
,TSVAL,,,109,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EMAILXML",TSPARM EQ "Email Address for XML File",C127791,text,C127791,
,TSVAL,,,110,SDTMIG v3.3,TS,EMA Decision number of Paediatric Investigation Plan,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000454-26/NL#A",European Medicines Agency (EMA),European Union Drug Regulating Authorities Clinical Trials Database (EudraCT),,,TSPARMCD EQ "EMPIPDCN",TSPARM EQ "EMA Decision Number for PIP",C126059,text,C126059,EMA
,TSVALCD,,,111,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "EMPIPDCN",TSPARM EQ "EMA Decision Number for PIP",C126059,,C126059,EMA
,TSVAL,,,112,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "EPIDEMIC",TSPARM EQ "Name of Epi/Pandemic",C171506,text,C171506,
,TSVAL,,,113,SDTMIG v3.3,TS,Sender Identifier,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.ema.europa.eu/en/documents/other/detailed-guide-regarding-eudravigilance-data-management-activities-european-medicines-agency_en.pdf",European Medicines Agency (EMA),EudraVigilance,,,TSPARMCD EQ "EVSNDID",TSPARM EQ "EudraVigilance Sender ID",C126061,text,C126061,EMA
,TSVALCD,,,114,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "EVSNDID",TSPARM EQ "EudraVigilance Sender ID",C126061,,C126061,EMA
,TSVAL,,,115,SDTMIG v3.3,TS,Sender Organisation,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://www.ema.europa.eu/en/documents/other/detailed-guide-regarding-eudravigilance-data-management-activities-european-medicines-agency_en.pdf",European Medicines Agency (EMA),EudraVigilance,,,TSPARMCD EQ "EVSNDORG",TSPARM EQ "EudraVigilance Sender Organization",C126090,text,C126090,EMA
,TSVALCD,,,116,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "EVSNDORG",TSPARM EQ "EudraVigilance Sender Organization",C126090,,C126090,EMA
,TSVAL,,,117,SDTMIG v3.3,TS,Expanded Access Record NCT Number,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://prsinfo.clinicaltrials.gov/definitions.html \n (Same blocker issue as where TSPARM EQ ""Registry Identifier"")",U.S. National Library of Medicine (US NLM),ClinicalTrials.gov,,,TSPARMCD EQ "EXPARECN",TSPARM EQ "Expanded Access Record NCT Number",C127792,text,C127792,
,TSVAL,,,118,SDTMIG v3.3,TS,Expanded Access Status,"Link to general information about the cited external dictionary, accessed 2023-02-09: https://prsinfo.clinicaltrials.gov/expanded_access_definitions.html",U.S. National Library of Medicine (US NLM),ClinicalTrials.gov,,,TSPARMCD EQ "EXPASTAT",TSPARM EQ "Expanded Access Status",C127793,text,C127793,
,TSVALCD,,,119,SDTMIG v3.3,TS,,TSVALCD is not applicable and is set to null for this trial summary parameter.,,,,,TSPARMCD EQ "EXPASTAT",TSPARM EQ "Expanded Access Status",C127793,,C127793,
,TSVAL,,,120,SDTMIG v3.3,TS,MeSH Term,"When the target trial registry is ClinicalTrials.gov, this parameter should contain MeSH terms, where appropriate. (https://prsinfo.clinicaltrials.gov/definitions.html) \n Link to general information about the cited external dictionary, accessed 2023-01-26: https://www.ncbi.nlm.nih.gov/mesh/",U.S. National Library of Medicine (US NLM),Medical Subject Headings (MeSH),,,TSPARMCD EQ "KEYWORD",TSPARM EQ "Protocol Keyword",C126062,text,C126062,
,TSVALCD,,,121,SDTMIG v3.3,TS,MeSH Unique ID,,U.S. National Library of Medicine (US NLM),Medical Subject Headings (MeSH),,,TSPARMCD EQ "KEYWORD",TSPARM EQ "Protocol Keyword",C126062,text,C126062,
,TSVAL,,,122,SDTMIG v3.3,TS,,This parameter may contain free form text when the target trial registry is not ClinicalTrials.gov.,,,,,TSPARMCD EQ "KEYWORD",TSPARM EQ "Protocol Keyword",C126062,text,C126062,
,TSVAL,,,123,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "LENGTH",TSPARM EQ "Trial Length",C49697,durationDatetime,C49697,
,TSVAL,,,124,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "NARMS",TSPARM EQ "Planned Number of Arms",C98771,integer,C98771,
,TSVAL,,,125,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "NCOHORT",TSPARM EQ "Number of Groups/Cohorts",C126063,integer,C126063,
,TSVAL,,,126,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "NUMSEUST",TSPARM EQ "Number of Trial Sites EU State",C127795,integer,C127795,
,TSVAL,,,127,SDTMIG v3.3,TS,,"Section 7.4.2 of SDTMIGv3.3, Assumption 9: ""A protocol may use multiple designations for objectives that are not primary (e.g., Secondary, Tertiary, and Exploratory), but all these non-primary objectives should be given as values of TSPARM = ""OBJSEC"".""",,,,,TSPARMCD EQ "OBJEXP",TSPARM EQ "Trial Exploratory Objective",C163559,text,C163559,
,TSVAL,,,128,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBJPRIM",TSPARM EQ "Trial Primary Objective",C85826,text,C85826,
,TSVAL,,,129,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBJSEC",TSPARM EQ "Trial Secondary Objective",C85827,text,C85827,
,TSVAL,,,130,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSTPOPD",TSPARM EQ "Obs Study Population Description",C126066,text,C126066,
,TSVAL,,,131,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OBSTSMMD",TSPARM EQ "Obs Study Sampling Method Description",C126068,text,C126068,
,TSVAL,,,132,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSADD",TSPARM EQ "Additional Outcome Measure",C156601,text,C156601,
,TSVAL,,,133,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSEXP",TSPARM EQ "Exploratory Outcome Measure",C98724,text,C98724,
,TSVAL,,,134,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSPRI",TSPARM EQ "Primary Outcome Measure",C98772,text,C98772,
,TSVAL,,,135,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "OUTMSSEC",TSPARM EQ "Secondary Outcome Measure",C98781,text,C98781,
,TSVAL,,,136,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PLANSUB",TSPARM EQ "Planned Number of Subjects",C49692,integer,C49692,
,TSVAL,,,137,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PLNTRDUR",TSPARM EQ "Planned Trial Duration",C127796,durationDatetime,C127796,
,TSVAL,,,138,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "PTRTDUR",TSPARM EQ "Planned Treatment Duration",C139276,durationDatetime,C139276,
,TSVAL,,,139,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RANDQT",TSPARM EQ "Randomization Quotient",C98775,float,C98775,
,TSVAL,,,140,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RESUBLTR",TSPARM EQ "Resubmission Letter",C126071,text,C126071,
,TSVAL,,,141,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RLPSCRIT",TSPARM EQ "Relapse Criteria",C117961,text,C117961,
,TSVAL,,,142,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "RTSPCDES",TSPARM EQ "Retained Biospecimen Description",C126072,text,C126072,
,TSVAL,,,143,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SDMDUR",TSPARM EQ "Stable Disease Minimum Duration",C98783,durationDatetime,C98783,
,TSVAL,,,144,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SENDTC",TSPARM EQ "Study End Date",C90462,datetime,C90462,
,TSVAL,,,145,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SEVCRIT",TSPARM EQ "Severity Criteria",C117962,text,C117962,
,TSVAL,,,146,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SPREFID",TSPARM EQ "Sponsor's Study Reference ID",C135009,text,C135009,
,TSVAL,,,147,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SSTDTC",TSPARM EQ "Study Start Date",C69208,datetime,C69208,
,TSVAL,,,148,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "SSTDYDTL",TSPARM EQ "Substudy Details",C126075,text,C126075,
,TSVAL,,,149,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "STOPRULE",TSPARM EQ "Study Stop Rules",C49698,text,C49698,
,TSVAL,,,150,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "STRATFCT",TSPARM EQ "Stratification Factor",C16153,text,C16153,
,TSVAL,,,151,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "THERAREA",TSPARM EQ "Therapeutic Area",C101302,text,C101302,
,TSVAL,,,152,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TITLE",TSPARM EQ "Trial Title",C49802,text,C49802,
,TSVAL,,,153,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "TRGFUDUR",TSPARM EQ "Target Follow-Up Duration",C126077,durationDatetime,C126077,
,TSVAL,,,154,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "URLSTDY",TSPARM EQ "URL Related to Study",C127801,text,C127801,
,TSVAL,,,155,SDTMIG v3.3,TS,,,,,,,TSPARMCD EQ "URLSTDYD",TSPARM EQ "URL Related to Study Description",C127802,text,C127802,
NY,TSVAL,No Yes Response,C66742,156,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,N; Y,C49487; C49488,TSPARMCD EQ "ONGOSIND",TSPARM EQ "Ongoing Study Indicator",C204699,text,C204699,
SDTMDVRS,TSVAL,SDTMIG Medical Device Version Response,C189266,157,SDTMIG v3.3,TS,,Populate TSVALCD with the corresponding NCIt c-code for the CDISC submission value in TSVAL.,,,,,TSPARMCD EQ "SDTMDVER",TSPARM EQ "SDTMIG Medical Device Version",C189317,text,C189317,
DOMAIN,DOMAIN,SDTM Domain Abbreviation,C66734,1,SDTMIG v3.3,TV,,,,,TV,C49621,,,,,,

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