SDTMIG Draft scraping for specifications

Role,Variable Name,Variable Label,Type,Description,Core,"Controlled Terms, Codelist, or Format",CDISC Notes,"Controlled Terms, Codelist or Format"
Identifier,STUDYID,Study Identifier,Char,Unique Identifier for a study.,Req,,,
Identifier,DOMAIN,Domain Abbreviation,Char,Two-character abbreviation for the domain.,Req,SI,,
Identifier,SITEID,Site Identifier,Char,Unique identifier for a site within a study.,Req,,,
Identifier,SISEQ,Sequence Number,Num,"Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same SIPARMCD, and can be used to join related records.",Req,,,
Identifier,SIGRPID,Group ID,Char,Used to tie together a group of related records.,Perm,,,
Topic,SIPARMCD,Site Summary Parameter Short Name,Char,"SIPARMCD (the companion to SIPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that SIPARMCD will need to serve as variable names.",Req,*,,
Synonym Qualifier,SIPARM,Site Summary Parameter,Char,Term for the Site Summary Parameter. The value in SIPARM cannot be longer than 40 character.,Req,*,,
Result Qualifier,SIVAL,Parameter Value,Char,Value of SIPARM.,Exp,*,,
Variable Qualifier,SIVALU,Parameter Units,Char,"Units for the value in SIVAL, if applicable.",Perm,(UNIT),,
Result Qualifier,SIVALNF,Parameter Null Flavor,Char,"Null flavor for the value of SIPARM, to be populated if and only if SIVAL is null.",Perm,ISO 21090 NullFlavor enumeration,,
Result Qualifier,SIVALCD,Parameter Value Code,Char,"This is the code of the term in SIVAL. For example; 6CW7F3G59X is the code for Gabapentin, C49488 is the code for Y. The length of this variable can be longer than 8 to accommodate the length of the external terminology.",Exp,*,,
Result Qualifier,SIVCDREF,Name of the Reference Terminology,Char,"The name of the Reference Terminology from which SIVALCD is taken. For example; CDISC, SNOMED, ISO 8601.",Exp,,,
Result Qualifier,SIVCDVER,Version of the Reference Terminology,Char,"The version number of the Reference Terminology, if applicable.",Exp,,,
Timing Variable,SIFSTDTC,Effective Start Date/Time,Char,"The start of the effective time period for the value in SIVAL, that is the time period during which the SIVAL is true.",Perm,ISO 8601,,
Timing Variable,SIFENDTC,Effective End Date/Time,Char,"The end of the effective time period for the value in SIVAL, that is the time period during which the SIVAL is true.",Perm,ISO 8601,,
Identifier,STUDYID,Study Identifier,Char,,Req,,Unique identifier for a study.,
Identifier,DOMAIN,Domain Abbreviation,Char,,Req,,Two-character abbreviation for the domain.,GI
Identifier,USUBJID,Unique Subject Identifier,Char,,Req,,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,
Identifier,GISEQ,Sequence Number,Num,,Req,,"Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.",
Identifier,GIGRPID,Group ID,Char,,Perm,,Used to link together a block of related records within a subject in a domain.,
Identifier,GIREFID,Reference ID,Char,,Perm,,Optional internal or external identifier such as central processing facility ID or medical image.,
Identifier,GISPID,Sponsor-Defined Identifier,Char,,Perm,,Sponsor-defined identifier. Example: pre-printed line identifier on a CRF page.,
Identifier,GILNKID,Link ID,Char,,Perm,,Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.,
Identifier,GILNKGRP,Link Group ID,Char,,Perm,,Identifier used to link related records across domains. This will usually be a many-to-one relationship.,
Topic,GITESTCD,"Short Name of Measurement, Test or Examination",Char,,Req,,"Short character value for GITEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: ""ELASTIC"", ""RTAVDIST"".",(GASTROCD )
Synonym Qualifier,GITEST,"Name of Measurement, Test or Examination",Char,,Req,,"Long name For GITESTCD. Examples: ""Elasticity"", ""Rectal Tumor to Anal Verge Distance"".",(GASTRO)
Grouping Qualifier,GICAT,Category,Char,,Perm,,"Used to define a category of topic-variable values. Examples: ""INTESTINAL DISEASE"", ""OSOPHAGEAL DISEASE"", ""RECTUM AND ANUS DISEASE"".",*
Grouping Qualifier,GISCAT,Subcategory,Char,,Perm,,Used to define a further categorization of GICAT values.,*
Result Qualifier,GIORRES,Result or Finding in Original Units,Char,,Exp,,"Result of the measurement or finding as originally received or collected. Examples: ""120"", ""<1"", ""POS"".",
Variable Qualifier,GIORRESU,Original Units,Char,,Perm,,"Unit for GIORRES. Examples: ""in"", ""LB"", ""kg/L"".",(UNIT)
Result Qualifier,GISTRESC,Result or Finding in Standard Format,Char,,Exp,,"Contains the result value for all findings, copied or derived from GIORRES in a standard format or in standard units. GISTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in GISTRESN. For example, if various tests have results ""NONE"", ""NEG"", and ""NEGATIVE"" in GIORRES and these results effectively have the same meaning, they could be represented in standard format in GISTRESC as ""NEGATIVE"".",
Result Qualifier,GISTRESN,Numeric Result/Finding in Standard Units,Num,,Perm,,Used for continuous or numeric results or findings in standard format; copied in numeric format from GISTRESC. GISTRESN should store all numeric test results or findings.,
Variable Qualifier,GISTRESU,Standard Units,Char,,Perm,,Standardized units used for GISTRESC and GISTRESN. Example: mol/L.,(UNIT)
Record Qualifier,GISTAT,Completion Status,Char,,Perm,,"Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE.",(ND)
Record Qualifier,GIREASND,Reason Not Done,Char,,Perm,,Reason not done. Used in conjunction with GISTAT when value is NOT DONE.,
Record Qualifier,GILOC,Location Used for the Measurement,Char,,Exp,,"Anatomical location of the subject relevant to the collection of the measurement. Example: ""RECTUM"", ""SMALL INTESTINE"".",(LOC)
Variable Qualifier,GILAT,Laterality,Char,,Perm,,"Qualifier for anatomical location or specimen further detailing laterality. Examples: ""RIGHT"", ""LEFT"", ""BILATERAL"".",(LAT)
Variable Qualifier,GIDIR,Directionality,Char,,Perm,,"Qualifier for anatomical location or specimen further detailing directionality. Examples: ""ANTERIOR"", ""LOWER"", ""PROXIMAL"".",(DIR)
Record Qualifier,GIMETHOD,Method of Test or Examination,Char,,Perm,,"Method of the test or examination. Example: ""ENDOSCOPY"". The different methods may offer different functionality or granularity, affecting the set of results and associated meaning.",(METHOD)
Record Qualifier,GILOBXFL,Last Observation Before Exposure Flag,Char,,Exp,,Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.,(NY)
Record Qualifier,GIBLFL,Baseline Flag,Char,,Perm,,Indicator used to identify a baseline value. Should be "Y" or null.,(NY)
Record Qualifier,GIDRVFL,Derived Flag,Char,,Perm,,"Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be ""Y"" or null.",(NY)
Timing,VISITNUM,Visit Number,Num,,Exp,,"Clinical encounter number. Numeric version of VISIT, used for sorting.",
Timing,VISIT,Visit Name,Char,,Perm,,Protocol-defined description of a clinical encounter.,
Timing,VISITDY,Planned Study Day of Visit,Num,,Perm,,Planned study day of VISIT. Should be an integer.,
Timing,TAETORD,Planned Order of Element within Arm,Num,,Perm,,Number that gives the planned order of the Element within the Arm (see Trial Arms).,
Timing,EPOCH,Epoch,Char,,Perm,,"Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.",
Timing,GIDTC,Date/Time of Collection,Char,,Exp,,Collection date and time of an observation.,ISO 8601
Timing,GIDY,Study Day of Visit/Collection/Exam,Num,,Perm,,Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,
Timing,GIDUR,Duration,Char,,Perm,,"Collected duration of an event, intervention, or finding. Used only if collected on the CRF and not derived.",ISO 8601
Timing,GITPT,Planned Time Point Name,Char,,Perm,,"Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See GITPTNUM and GITPTREF.",
Timing,GITPTNUM,Planned Time Point Number,Num,,Perm,,Numeric version of planned time point used in sorting.,
Timing,GIELTM,Planned Elapsed Time from Time Point Ref,Char,,Perm,,"Planned Elapsed time relative to a planned fixed reference GITPTREF) such as ""Previous Dose"" or ""Previous Meal"". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.",ISO 8601
Timing,GITPTREF,Time Point Reference,Char,,Perm,,"Description of the fixed reference point referred to by GIELTM, GITPTNUM, and GITPT. Examples: ""PREVIOUS DOSE"", ""PREVIOUS MEAL"".",
Timing,GIRFTDTC,Date/Time of Reference Time Point,Char,,Perm,,Date/time for a fixed reference time point defined by GITPTREF.,ISO 8601
Identifier,STUDYID,Study Identifier,Char,,Req,,Unique identifier for a study.,
Identifier,DOMAIN,Domain Abbreviation,Char,,Req,,Two-character abbreviation for the domain.,SB
Identifier,USUBJID,Unique Subject Identifier,Char,,Req,,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,
Identifier,SPDEVID,Sponsor Device Identifier,Char,,Perm,,Sponsor-defined identifier for a device,
Identifier,SBSEQ,Sequence Number,Num,,Req,,"Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.",
Identifier,SBGRPID,Group ID,Char,,Perm,,"Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in the Trial Summary dataset.",
Identifier,SBREFID,Reference ID,Char,,Perm,,"Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.",
Identifier,SBSPID,Sponsor-Defined Identifier,Char,,Perm,,Sponsor-defined identifier. Example: pre-printed line identifier on a Concomitant Medications page.,
Identifier,SBLNKID,Link ID,Char,,Perm,,Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. For Example: A single tumor may have multiple measurements/assessments performed at each study visit.,
Identifier,SBLNKGRP,Link Group ID,Char,,Perm,,Identifier used to link related records across domains. This will usually be a many-to-one relationship. For example: Multiple tumor measurements/assessments will contribute to a single response to therapy determination record.,
Topic,SBTESTCD,"Short Name of Measurement, Test or Examination",Char,,Req,,"Short character value for SBTEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: PLAT, SYSBP, RRMIN, EYEEXAM.",STBMRKR
Synonym Qualifier,SBTEST,"Name of Measurement, Test or Examination",Char,,Req,,"Long name For SBTESTCD. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination.",Study Biomarker
Variable Qualifier,SBTSTDTL,"Measurement, Test or Examination Detail",Char,,Perm,,Further description of SBTESTCD and SBTEST. Example: "The percentage of cells with +1 intensity of staining" when MITESTCD = TTF1.,
Variable Qualifier,SBGENRI,Genetic Region of Interest,Char,,Perm,,"The portion of the genome serving as a locus for the experiment/test. Often the short name, or symbol, for a gene. For human genetic data, these are typically obtained from the gene symbol list maintained by HGNC. Examples: EGFR, KRAS, CYP2D6",*
Variable Qualifier,SBGENTYP,Type of Genetic Region of Interest,Char,,Perm,,"The type of portion of the genome serving as a locus for the experiment/test. Examples: GENE, SECTOR, PROTEIN",(GENTYP)
Variable Qualifier,SBREFSEQ,Reference Sequence,Char,,Perm,,"A unique identifier for the reference sequence used to identify the genetic variation. Examples: NM_001234, rs02973492",
Variable Qualifier,SBGENLI,Genetic Location of Interest,Char,,Perm,,Specifies the location within the sequence pertaining to the value in PFGENTRG.,
Variable Qualifier,SBGENTRG,Genetic Target,Char,,Perm,,The nucleotide or amino acid being targeted. PFGENLI and PFGENTRG are used only when the test/experiment measures or detects a specific variation to the exclusion of all others.,
Grouping Qualifier,SBCAT,Category,Char,,Perm,,Used to define a category of topic-variable values. Example: RESISTANCE,
Grouping Qualifier,SBSCAT,Subcategory,Char,,Perm,,Used to define a further categorization of SBCAT values. Example: DIFFERENTIAL.,
Grouping Qualifier,SBSPCES,Non-Host Organism Species,Char,,Perm,,"Biological classification for a non-host organism. Examples: BACTERIUM, HCV, HIV, PLASMODIA",
Record Qualifier,NHOID,Non-Host Organism Identifier,Char,,Perm,,Identifier for non-host organism which is the subject of the finding. This is a value defined in the OI domain.,
Result Qualifier,SBORRES,Result or Finding in Original Units,Char,,Exp,,"Result of the measurement or finding as originally received or collected. Examples: 120, <1, POS.",
Variable Qualifier,SBORRESU,Original Units,Char,,Exp,,"Unit for SBORRES. Examples: IN, LB, kg/L.",(UNIT)
Variable Qualifier,SBORREF,Reference Result in Original Units,Char,,Perm,,"Reference value for the result or finding as originally received or collected. SBORREF uses the same units as SBORRES, if applicable. Examples: value from predicted normal value in spirometry tests.",
Variable Qualifier,SBGENLOC,Genetic Location,Char,,Perm,,Specifies the location within a sequence for the observed value in PFORRES.,
Variable Qualifier,SBGENSR,Genetic Sub-Region,Char,,Perm,,"The portion of the locus in which the variation was found. Examples: Exon 15, Kinase sector.",*
Result Qualifier,SBSTRESC,Result or Finding in Standard Format,Char,,Exp,,"Contains the result value for all findings, copied or derived from SBORRES in a standard format or in standard units. SBSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SBSTRESN. The value of SBORRES is a study biomarker identifer (PBMRKRID) value defined in the PB dataset.",*
Result Qualifier,SBSTRESN,Numeric Result/Finding in Standard Units,Num,,Perm,,Used for continuous or numeric results or findings in standard format; copied in numeric format from SBSTRESC. SBSTRESN should store all numeric test results or findings.,
Variable Qualifier,SBSTRESU,Standard Units,Char,,Perm,,Standardized units used for SBSTRESC and SBSTRESN. Example: mol/L.,(UNIT)
Variable Qualifier,SBRESCAT,Result Category,Char,,Perm,,Used to categorize the result of a finding. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation.,
Record Qualifier,SBSTAT,Completion Status,Char,,Perm,,"Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE.",(ND)
Record Qualifier,SBREASND,Reason Not Done,Char,,Perm,,Reason not done. Used in conjunction with SBSTAT when value is NOT DONE.,
Record Qualifier,SBXFN,External File Path,Char,,Perm,,"Filename for an external file, such as one for an ECG waveform or a medical image.",
Record Qualifier,SBNAM,Laboratory/Vendor Name,Char,,Perm,,"Name or identifier of the vendor (e.g., laboratory) that provided the test results.",
Record Qualifier,SBSPEC,Specimen Material Type,Char,,Perm,,"Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, DNA, RNA.",(GENSMP)
Record Qualifier,SBMUTYP,Mutation Type,Char,,Perm,,"Used to identify whether the variation is inheritable. Examples: GERMLINE, SOMATIC.",(MUTYP)
Record Qualifier,SBMETHOD,Method of Test or Examination,Char,,Perm,,"Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK",(METHOD)
Record Qualifier,SBLOBXFL,Last Observation Before Exposure Flag,Char,,Perm,,Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.,( NY )
Record Qualifier,SBBLFL,Baseline Flag,Char,,Perm,,Indicator used to identify a baseline value. Should be Y or null.,( NY )
Record Qualifier,SBDRVFL,Derived Flag,Char,,Perm,,"Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be Y or null.",( NY )
Variable Qualifier,SBLLOQ,Lower Limit of Quantitation,Num,,Perm,,Indicates the lower limit of quantitation for an assay. Units will be those used for SBSTRESU.,
Variable Qualifier,SBULOQ,Upper Limit of Quantitation,Num,,Perm,,Indicates the upper limit of quantitation for an assay. Units will be those used for SBSTRESU.,
Record Qualifier,SBREPNUM,Repeat Number,Num,,Perm,,Used to indicate the chronological order of repeated tests.,
Timing,VISITNUM,Visit Number,Num,,Perm,,"Clinical encounter number. Numeric version of VISIT, used for sorting.",
Timing,VISIT,Visit Name,Char,,Perm,,Protocol-defined description of a clinical encounter.,
Timing,VISITDY,Planned Study Day of Visit,Num,,Perm,,Planned study day of VISIT. Should be an integer.,
Timing,TAETORD,Planned Order of Element within Arm,Num,,Perm,,Number that gives the planned order of the Element within the Arm (see Trial Arms).,
Timing,EPOCH,Epoch,Char,,Perm,,"Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.",
Timing,SBDTC,Date/Time of Specimen Collection,Char,,Perm,,Collection date and time of specimen collection.,ISO 8601
Timing,SBDY,Study Day of Specimen Collection,Num,,,,Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,
Timing,SBTPT,Planned Time Point Name,Char,,Perm,,"Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See SBTPTNUM and SBTPTREF.",
Timing,SBTPTNUM,Planned Time Point Number,Num,,Perm,,Numeric version of planned time point used in sorting.,
Timing,SBELTM,Planned Elapsed Time from Time Point Ref,Char,,Perm,,"Planned Elapsed time relative to a planned fixed reference SBTPTREF) such as ""Previous Dose"" or ""Previous Meal"". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.",ISO 8601
Timing,SBTPTREF,Time Point Reference,Char,,Perm,,"Description of the fixed reference point referred to by SBELTM, SBTPTNUM, and SBTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.",
Timing,SBRFTDTC,Date/Time of Reference Time Point,Char,,Perm,,Date/time for a fixed reference time point defined by SBTPTREF.,ISO 8601
Identifier,STUDYID,Study Identifier,Char,,Req,,Unique identifier for a study.,
Identifier,DOMAIN,Domain Abbreviation,Char,,Req,,Two-character abbreviation for the domain.,QT
Identifier,USUBJID,Unique Subject Identifier,Char,,Req,,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,
Identifier,QTSEQ,Sequence Number,Num,,Req,,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,
Identifier,QTGRPID,Group ID,Char,,Perm,,Used to tie together a block of related records in a single domain for a subject. Example: Used to group a correction method with its formula and coefficient values.,
Topic,QTTESTCD,QTc Test or Examination Short Name,Char,,Req,,"Short name of the QT correction property described in QTTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in QTTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., ""1TEST"" is not valid). QTTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: ""QTCDESC"", ""QTCFORM"".",*
Synonym Qualifier,QTTEST,QTc Test or Examination Name,Char,,Req,,"Verbatim name of the QT correction property. The value in QTTEST cannot be longer than 40 characters. Examples: ""QT Correction Method Description"", ""QT Correction Formula"".",*
Result Qualifier,QTORRES,Result or Finding in Original Units,Char,,Exp,,"Result of the QT correction model measurement or finding as originally received or collected. Examples of expected values are ""0.132"" or ""0.432"" when the result is a coefficient or measurement, or ""LINEAR"" or ""PARABOLIC LOG/LOG"" when the result is a formula.",
Result Qualifier,QTSTRESC,Character Result/Finding in Std Format,Char,,Exp,,"Contains the result value for all findings, copied or derived from QTORRES in a standard format or standard units. QTSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in QTSTRESN, for example ""0.132"" or ""0.432"" when the result is a coefficient or measurement, or ""LINEAR"" or ""PARABOLIC LOG/LOG"" when the result is a formula.",*
Result Qualifier,QTSTRESN,Numeric Result/Finding in Standard Units,Num,,Perm,,Used for continuous or numeric results or findings in standard format; copied in numeric format from QTSTRESC. QTSTRESN should store all numeric test results or findings.,
Record Qualifier,QTSTAT,Completion Status,Char,,Perm,,Used to indicate a QT correction model was not done. Should be null if a result exists in QTORRES.,(ND)
Record Qualifier,QTREASND,Reason Not Done,Char,,Perm,,Describes why a measurement or test was not performed. Used in conjunction with QTSTAT when correction is NOT DONE.,
Record Qualifier,QTNAM,Vendor Name,Char,,Perm,,Name or identifier of the laboratory or vendor who provided the test results.,
Record Qualifier,QTDRVFL,Derived Flag,Char,,Perm,,"Used to indicate a derived record. The value should be ""Y"" or null. Records which represent the average of other records, or that do not come from the CRF, or are not as originally collected or received are examples of records that would be derived for the submission datasets. If QTDRVFL = ""Y"", then QTORRES should be null, with QTSTRESC, and (if numeric) QTSTRESN having the derived value.",(NY)
Identifier,STUDYID,Study Identifier,Char,,Req,,Unique identifier for a study.,
Identifier,DOMAIN,Domain Abbreviation,Char,,Req,TL,Two-character abbreviation for the domain.,
Identifier,RDOMAIN,Related Domain Abbreviation,Char,,Req,,Two-character abbreviation for the related domain.,
Identifier,TLVAR1,Identifying Variable1,Char,,Req,*,Identifying variable in the parent dataset that identifies the record(s) to which the parameter applies. The short value can be up to 8 characters and must be that of an existing variable in the dataset referred to by RDOMAIN. Examples: IACAT or LBTESTCD.,
Identifier,TLVRVAL1,Identifying Value for Variable 1,Char,,Req,,"Value of identifying variable referred to by TLVAR1 of the parent record(s). The content of this variable is controlled by the information present in the identifying variable, TLVAR1. Examples: DERMAL, PLAT, GLUC.",
Identifier,TLVAR2,Identifying Variable 2,Char,,Perm,*,Identifying variable in the parent dataset that further specifies the record(s) to which the parameter applies. The short value can be up to 8 characters and must be that of an existing variable in the dataset referred to by RDOMAIN. Examples: IATEST or LBPEC.,
Identifier,TLVRVAL2,Identifying Value for Variable 2,Char,,Perm,,"Value of identifying variable referred to by TLVAR2 of the parent record(s). The content of this variable is controlled by the information present in the identifying variable, TLVAR2. Examples: Erythema/Eschar, WHOLE BLOOD, URINE.",
Identifier,TLVAR3,Identifying Variable 3,Char,,Perm,*,Identifying variable in the parent dataset that further specifies the record(s) to which the parameter applies. The short value can be up to 8 characters and must be that of an existing variable in the dataset referred to by RDOMAIN. Examples: RGMETHOD or LBMETHOD.,
Identifier,TLVRVAL3,Identifying Value for Variable 3,Char,,Perm,,"Value of identifying variable referred to by TLVAR3 of the parent record(s). The content of this variable is controlled by the information present in the identifying variable, TLVAR3. Examples: ISCEV standard, ELECTROPHORESIS, DIPSTICK,",
Identifier,TLSEQ,Sequence Number,Num,,Perm,,Unique number for this record within this dataset.,
Identifier,TLGRPID,Group Identifier,Char,,Exp,,"Used to tie together a group of related records within a unique combination of RDOMAIN, TLVARs and TLVRVALs, such as linking a unit to a value for instrument settings. This is not the sponsor-defined protocol group number.",
Topic,TLPARMCD,Trial Lookup Parameter Code,Char,,Req,(TLPARMCD),Short character value for the Trial Test Lookup parameter described in TLPARM. Maximum 8 characters.,
Synonym Qualifier of TLPARMCD,TLPARM,Trial Lookup Parameter,Char,,Req,(TLPARM),Term for the Trial Test Lookup parameter. Maximum 40 characters.,
Result Qualifier,TLVAL,Trial Lookup Parameter Value,Char,,Exp,,"Value of the Trial Lookup parameter (e.g., Fed ad libitum or Restricted Feeding when TLPARMCD is FEEDREG). Some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section XX, that lists pre-defined Trial Lookup parameters.",
Result Qualifier,TLVAL1,Trial Lookup Parameter Value 1,Char,,Perm,,"First 200 character extension to the value of the Trial Lookup parameter (e.g., Fed ad libitum or Restricted Feeding when TLPARMCD is FEEDREG). Some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section XX, that lists pre-defined Trial Lookup parameters.",
Synonym Qualifier of TLVAL,TLVALCD,Trial Lookup Parameter Code,Char,,Exp,,The coded value for which TLVAL represents the DECODE. Should be used when describing scores on a scale.,
Record Qualifier,TLRL,Trial Lookup Rule,Char,,,,"***IN PROGRESS*** Skip rule and other use cases Example: QRS Any condition that is met in which you skip the parameters and other defined Description of a time when skipped Machine readable? Example: If ABC0101 = N, then skip to ABC0103 Mike H: Rule that expresses the criterion(s) in computer-executable form. For example, an instrument that has a logical skip criterion.",
Identifier,STUDYID,Study Identifier,Char,,Req,,Unique identifier for a study.,
Identifier,DOMAIN,Domain Abbreviation,Char,,Req,,Two-character abbreviation for the domain most relevant to the observation. The Domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.,ER
Identifier,USUBJID,Unique Subject Identifier,Char,,Req,,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,
Identifier,ERSEQ,Sequence Number,Num,,Req,,Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1.,
Identifier,ERGRPID,Group ID,Char,,Perm,,"Optional group identifier, used to link together a block of related records within a subject in a domain.",
Identifier,ERREFID,Reference ID,Char,,Perm,,Optional internal or external identifier.,
Identifier,ERSPID,Sponsor-Defined Identifier,Char,,Perm,,"Sponsor-defined identifier, such as a pre-printed line identifier.",
Identifier,ERLNKID,Link ID,Char,,Perm,,Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.,
Identifier,ERLNKGRP,Link Group ID,Char,,Perm,,Identifier used to link related records across domains. This will usually be a many-to-one relationship.,
Topic,ERTERM,Reported Term,Char,,Req,,"Topic variable for an event observation, which is the verbatim or pre-specified name of the event.",
Grouping Qualifier,ERCAT,Category,Char,,Perm,,Used to define a category of topic-variable values.,*
Grouping Qualifier,ERSCAT,Subcategory,Char,,Perm,,Used to define a further categorization of ERCAT values.,*
Variable Qualifier,ERPRESP,Pre-specified,Char,,Perm,,"Used to indicate whether the event described by ERTERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.",(NY)
Record Qualifier,EROCCUR,Occurrence,Char,,Perm,,Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited.,(NY)
Record Qualifier,ERSTAT,Completion Status,Char,,Perm,,Used to indicate when a question about the occurrence of a pre-specified event was not answered. Should be null or have a value of NOT DONE.,(ND)
Record Qualifier,ERREASND,Reason Not Done,Char,,Perm,,Reason not done. Used in conjunction with ERSTAT when its value is NOT DONE.,
Record Qualifier,ERPATT,Pattern of Event,Char,,Perm,,"Used to indicate the pattern of the event over time. Examples: ""INTERMITTENT"", ""CONTINUOUS"", ""SINGLE EVENT"".",
Timing,VISITNUM,Visit Number,Num,,Perm,,"Clinical encounter number. Numeric version of VISIT, used for sorting.",
Timing,VISIT,Visit Name,Char,,Perm,,Protocol-defined description of a clinical encounter.,
Timing,VISITDY,Planned Study Day of Visit,Num,,Perm,,Planned study day of VISIT. Should be an integer.,
Timing,TAETORD,Planned Order of Element within Arm,Num,,Perm,,Number that gives the planned order of the Element within the Arm for the Element in which the environmental risk factor event started. Null if the event started before study participation.,
Timing,EPOCH,Epoch,Char,,Perm,,Epoch associated with the start date/time of the environmental risk factor event. Null if the event started before study participation.,(EPOCH)
Timing,ERDTC,Date/Time of Collection,Char,,Perm,,Collection date and time of an observation represented in ISO 8601 character format.,ISO 8601
Timing,ERSTDTC,Start Date/Time of Observation,Char,,Perm,,Start date/time of an observation represented in ISO 8601 character format.,ISO 8601
Timing,ERENDTC,End Date/Time of Observation,Char,,Perm,,End date/time of the observation represented in ISO 8601 character format.,ISO 8601
Timing,ERDY,Study Day of Visit/Collection/Exam,Num,,Perm,,Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,
Timing,ERSTDY,Study Day of Start of Observation,Num,,Perm,,Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,
Timing,ERENDY,Study Day of End of Observation,Num,,Perm,,Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,
Timing,ERDUR,Duration,Char,,Perm,,Collected duration of event represented in ISO 8601 character format. Used only if collected on the CRF and not derived.,ISO 8601
Timing,ERTPT,Planned Time Point Name,Char,,Perm,,"Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See ERTPTNUM and ERTPTREF.",
Timing,ERTPTNUM,Planned Time Point Number,Num,,Perm,,Numeric version of planned time point used in sorting.,
Timing,ERELTM,Planned Elapsed Time from Time Point Ref,Char,,Perm,,"Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference (ERTPTREF) such as ""Previous Dose"" or ""Previous Meal"". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.",ISO 8601
Timing,ERTPTREF,Time Point Reference,Char,,Perm,,"Description of the fixed reference point referred to by ERELTM, ERTPTNUM, and ERTPT. Examples: ""PREVIOUS DOSE"", ""PREVIOUS MEAL"".",
Timing,ERRFTDTC,Date/Time of Reference Time Point,Char,,Perm,,Date/time for a fixed reference time point defined by ERTPTREF in ISO 8601 character format.,ISO 8601
Timing,ERSTRF,Start Relative to Reference Period,Char,,Perm,,"Identifies the start of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. This variable had been considered for possible deprecation in a future (post SDTM v1.5) release; however, upon further consideration this variable will be retained.",(STENRF)
Timing,ERENRF,End Relative to Reference Period,Char,,Perm,,"Identifies the end of the observation as being before, during or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. This variable had been considered for possible deprecation in a future (post SDTM v1.5) release; however, upon further consideration this variable will be retained.",(STENRF)
Timing,EREVLINT,Evaluation Interval,Char,,Perm,,"Duration of interval associated with an event such as a symptom, represented in ISO 8601 character format. Example: ""-P2M"" to represent a period of the past 2 months as the evaluation interval for an event.",ISO 8601
Timing,EREVINTX,Evaluation Interval Text,Char,,Perm,,"Evaluation interval associated with an event, where the interval is not able to be represented in ISO 8601 format. Examples: ""LIFETIME"", ""LAST NIGHT"", ""RECENTLY"", ""OVER THE LAST FEW WEEKS"".",
Timing,ERSTRTPT,Start Relative to Reference Time Point,Char,,Perm,,Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable ERSTTPT.,(STENRF)
Timing,ERSTTPT,Start Reference Time Point,Char,,Perm,,Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by ERSTRTPT. Examples: "2003-12-15" or "VISIT 1".,
Timing,ERENRTPT,End Relative to Reference Time Point,Char,,Perm,,Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable ERENTPT.,(STENRF)
Timing,ERENTPT,End Reference Time Point,Char,,Perm,,Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by ERENRTPT. Examples: "2003-12-25" or "VISIT 2".,