| Source Page | TATOBA:SDTM specifications |
|---|---|
| Valid Tables | 41 |
| Destination | Library |
| Options |
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| Output Format | Table |
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core | Dataset Name | Variable Name (no prefix) | Seq. for Order | Observation Class | Domain Prefix |
|---|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | AE | STUDYID | 1 | SDTM Events | ||
| DOMAIN | Domain Abbreviation | Char | AE | Identifier | Two-character abbreviation for the domain. | Req | AE | DOMAIN | 2 | SDTM Events | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | AE | USUBJID | 3 | SDTM Events | ||
| SPDEVID | Applicant Device Identifier | Char | Identifier | A sequence of characters used by the applicant to uniquely identify a specific device. Used to represent a device associated in some way with the adverse experience. SPDEVID values are defined in the Device Identifiers (DI) domain. | Perm | AE | SPDEVID | 4 | SDTM Events | ||
| AESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | AE | SEQ | 5 | SDTM Events | AE | |
| AEGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | AE | GRPID | 6 | SDTM Events | AE | |
| AEREFID | Reference ID | Char | Identifier | Internal or external identifier such as a serial number on an SAE reporting form. | Perm | AE | REFID | 7 | SDTM Events | AE | |
| AESPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined identifier. It may be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on an Adverse Experiences CRF page. | Perm | AE | SPID | 8 | SDTM Events | AE | |
| AETERM | Reported Term for the Adverse Experience | Char | Topic | Verbatim name of the experience. | Req | AE | TERM | 9 | SDTM Events | AE | |
| AEMODIFY | Modified Reported Term | Char | Synonym Qualifier | If AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text. | Perm | AE | MODIFY | 10 | SDTM Events | AE | |
| AELLT | Lowest Level Term | Char | MedDRA | Variable Qualifier | Dictionary-derived text description of the lowest level term. | Exp | AE | LLT | 11 | SDTM Events | AE |
| AELLTCD | Lowest Level Term Code | Num | MedDRA | Variable Qualifier | Dictionary-derived code for the lowest level term. | Exp | AE | LLTCD | 12 | SDTM Events | AE |
| AEDECOD | Dictionary-Derived Term | Char | MedDRA | Synonym Qualifier | Dictionary-derived text description of AETERM or AEMODIFY. Equivalent to the Preferred Term (PT in MedDRA). The applicant is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document. | Req | AE | DECOD | 13 | SDTM Events | AE |
| AEPTCD | Preferred Term Code | Num | MedDRA | Variable Qualifier | Dictionary-derived code for the preferred term. | Exp | AE | PTCD | 14 | SDTM Events | AE |
| AEHLT | High Level Term | Char | MedDRA | Variable Qualifier | Dictionary-derived text description of the high level term for the primary system organ class (SOC). | Exp | AE | HLT | 15 | SDTM Events | AE |
| AEHLTCD | High Level Term Code | Num | MedDRA | Variable Qualifier | Dictionary-derived code for the high level term for the primary SOC. | Exp | AE | HLTCD | 16 | SDTM Events | AE |
| AEHLGT | High Level Group Term | Char | MedDRA | Variable Qualifier | Dictionary-derived text description of the high level group term for the primary SOC. | Exp | AE | HLGT | 17 | SDTM Events | AE |
| AEHLGTCD | High Level Group Term Code | Num | MedDRA | Variable Qualifier | Dictionary-derived code for the high level group term for the primary SOC. | Exp | AE | HLGTCD | 18 | SDTM Events | AE |
| AECAT | Category for Adverse Experience | Char | Grouping Qualifier | Used to define a category of related records. Examples: "BLEEDING", "NEUROPSYCHIATRIC". | Perm | AE | CAT | 19 | SDTM Events | AE | |
| AESCAT | Subcategory for Adverse Experience | Char | Grouping Qualifier | A further categorization of adverse experience. Example: "NEUROLOGIC". | Perm | AE | SCAT | 20 | SDTM Events | AE | |
| AEPRESP | Pre-Specified Adverse Experience | Char | (NY) | Variable Qualifier | A value of "Y" indicates that this adverse experience was prespecified on the CRF. Values are null for spontaneously reported experiences (i.e., those collected as free-text verbatim terms). | Perm | AE | PRESP | 21 | SDTM Events | AE |
| AEBODSYS | Body System or Organ Class | Char | Record Qualifier | Dictionary derived. Body system or organ class used by the applicant from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the 's analyses and summary tables, which may not necessarily be the primary SOC. | Exp | AE | BODSYS | 22 | SDTM Events | AE | |
| AEBDSYCD | Body System or Organ Class Code | Num | MedDRA | Variable Qualifier | Dictionary derived. Code for the body system or organ class used by the applicant When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the applicant's analyses and summary tables, which may not necessarily be the primary SOC. | Exp | AE | BDSYCD | 23 | SDTM Events | AE |
| AESOC | Primary System Organ Class | Char | MedDRA | Variable Qualifier | Dictionary-derived text description of the primary SOC. Will be the same as AEBODSYS if the primary SOC was used for analysis. | Exp | AE | SOC | 24 | SDTM Events | AE |
| AESOCCD | Primary System Organ Class Code | Num | MedDRA | Variable Qualifier | Dictionary-derived code for the primary SOC. Will be the same as AEBDSYCD if the primary SOC was used for analysis. | Exp | AE | SOCCD | 25 | SDTM Events | AE |
| AELOC | Location of Experience | Char | (LOC) | Record Qualifier | Describes anatomical location relevant for the experience (e.g., "ARM" for skin rash). | Perm | AE | LOC | 26 | SDTM Events | AE |
| AESEV | Severity/Intensity | Char | (AESEV) | Record Qualifier | The severity or intensity of the experience. Examples: "MILD", "MODERATE", "SEVERE". | Perm | AE | SEV | 27 | SDTM Events | AE |
| AESER | Serious Experience | Char | (NY) | Record Qualifier | Is this a serious experience? Valid values are "Y" and "N". | Exp | AE | SER | 28 | SDTM Events | AE |
| AEACN | Action Taken with Study Product | Char | (TPACN) | Record Qualifier | Describes actions taken with study product, as the result of the experience. | Exp | AE | ACN | 29 | SDTM Events | AE |
| AEACNOTH | Other Action Taken | Char | Record Qualifier | Describes actions taken unrelated to study product, as the result of the experience. | Perm | AE | ACNOTH | 30 | SDTM Events | AE | |
| AEACNDEV | Action Taken with Device | Char | (DEACNDEV) | Record Qualifier | An action taken with a device as the result of the experience. The device may or may not be a device under study. | Perm | AE | ACNDEV | 31 | SDTM Events | AE |
| AEREL | Causality | Char | Record Qualifier | Records the investigator's opinion as to the causality of the experience to the product. ICH does not establish any required or recommended terms for non-device relatedness. ICH E2A and E2B examples include (up-cased here for alignment to SDTM conventions) terms such as "NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED", but these example terms do not establish any conventions or expectations. Controlled terminology may be defined in the future. Check with regulatory authority for population of this variable. | Exp | AE | REL | 32 | SDTM Events | AE | |
| AERLDEV | Relationship of Experience to Device | Char | Record Qualifier | A judgment as to the likelihood that the device caused the adverse experience. The relationship is to a device identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study. \n Terminology: \n * In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions. \n * No required Controlled Terminology in US. | Perm | AE | RLDEV | 33 | SDTM Events | AE | |
| AERELNST | Relationship to Non-Study Trtmnt or Prod | Char | Record Qualifier | Records the investigator's opinion as to whether the experience may have been due to a treatment or product other than study product. May be reported as free text. Example: "MORE LIKELY RELATED TO METHYLPHENIDATE USE". | Perm | AE | RELNST | 34 | SDTM Events | AE | |
| AEPATT | Pattern of Adverse Experience | Char | Record Qualifier | Used to indicate the pattern of the experience over time. Examples: "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT". | Perm | AE | PATT | 35 | SDTM Events | AE | |
| AEOUT | Outcome of Adverse Experience | Char | (OUT) | Record Qualifier | Description of the outcome of an experience. | Perm | AE | OUT | 36 | SDTM Events | AE |
| AESCAN | Involves Cancer | Char | (NY) | Record Qualifier | Was the serious experience associated with the development of cancer? Valid values are "Y" and "N". This is a legacy seriousness criterion. It is not included in ICH E2A or E2B. | Perm | AE | SCAN | 37 | SDTM Events | AE |
| AESCONG | Congenital Anomaly or Birth Defect | Char | (NY) | Record Qualifier | Was the serious experience associated with congenital anomaly or birth defect? Valid values are "Y" and "N". | Perm | AE | SCONG | 38 | SDTM Events | AE |
| AESDISAB | Persist or Signif Disability/Incapacity | Char | (NY) | Record Qualifier | Did the serious experience result in persistent or significant disability/incapacity? Valid values are "Y" and "N". | Perm | AE | SDISAB | 39 | SDTM Events | AE |
| AESDTH | Results in Death | Char | (NY) | Record Qualifier | Did the serious experience result in death? Valid values are "Y" and "N". | Perm | AE | SDTH | 40 | SDTM Events | AE |
| AESHOSP | Requires or Prolongs Hospitalization | Char | (NY) | Record Qualifier | Did the serious experience require or prolong hospitalization? Valid values are "Y" and "N". | Perm | AE | SHOSP | 41 | SDTM Events | AE |
| AESLIFE | Is Life Threatening | Char | (NY) | Record Qualifier | Was the serious experience life-threatening? Valid values are "Y" and "N". | Perm | AE | SLIFE | 42 | SDTM Events | AE |
| AESOD | Occurred with Overdose | Char | (NY) | Record Qualifier | Did the serious experience occur with an overdose? Valid values are "Y" and "N". This is a legacy seriousness criterion. It is not included in ICH E2A or E2B. | Perm | AE | SOD | 43 | SDTM Events | AE |
| AESMIE | Other Medically Important Serious Event | Char | (NY) | Record Qualifier | Do additional categories for seriousness apply? Valid values are "Y" and "N". | Perm | AE | SMIE | 44 | SDTM Events | AE |
| AESINTV | Needs Intervention to Prevent Impairment | Char | (NY) | Record Qualifier | Records whether medical or surgical intervention was necessary to preclude permanent impairment of a body function, or to prevent permanent damage to a body structure, with either situation suspected to be due to the use of a medical product. This variable is used in conjunction with the other "seriousness" variables (e.g., fatal, life-threatening). It is part of the US federal government definition of a serious adverse event; see 21 CFR Part 803.3(w)(3). | Perm | AE | SINTV | 45 | SDTM Events | AE |
| AEUNANT | Unanticipated Adverse Device Effect | Char | (NY) | Record Qualifier | Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), \n or \n any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. (21 CFR Part 812.3(s)). \n This variable applies only to serious AEs and should hold collected data; if the value is derived, it should be held in ADaM. | Perm | AE | UNANT | 46 | SDTM Events | AE |
| AERLPRT | Rel of AE to Non-Dev-Rel Study Activity | Char | Record Qualifier | The investigator's opinion as to the causality of the experience as related to other protocol-required activities, actions, or assessments (e.g., medication changes, tests/assessments, other procedures). The relationship is to a protocol-specified, non-device-related activity where the device is identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study. \n Terminology:In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions.No required Controlled Terminology in US. | Perm | AE | RLPRT | 47 | SDTM Events | AE | |
| AERLPRC | Rel of AE to Device-Related Procedure | Char | Record Qualifier | The investigator's opinion as to the likelihood that the device-related study procedure (e.g., implant/insertion, revision/adjustment, explant/removal) caused the AE. The relationship is to a device-related procedure where the device is identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study. \n Terminology:In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions.No required Controlled Terminology in US. | Perm | AE | RLPRC | 48 | SDTM Events | AE | |
| AECONTRT | Concomitant or Additional Trtmnt Given | Char | (NY) | Record Qualifier | Was another treatment given because of the occurrence of the experience? Valid values are "Y" and "N". | Perm | AE | CONTRT | 49 | SDTM Events | AE |
| AETOXGR | Standard Toxicity Grade | Char | Record Qualifier | Toxicity grade according to a standard toxicity scale (e.g., Common Terminology Criteria for Adverse Events, CTCAE). Applicants should specify the name of the scale and version used in the metadata (see assumption 7d). If value is from a numeric scale, represent only the number (e.g., "2", not "Grade 2"). | Perm | AE | TOXGR | 50 | SDTM Events | AE | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm. | Perm | AE | TAETORD | 51 | SDTM Events | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the adverse experience. Example: "SCREENING". | Perm | AE | EPOCH | 52 | SDTM Events | |
| AESTDTC | Start Date/Time of Adverse Experience | Char | ISO 8601 datetime or interval | Timing | Start date/time of the adverse experience represented in ISO 8601 character format. | Exp | AE | STDTC | 53 | SDTM Events | AE |
| AEENDTC | End Date/Time of Adverse Experience | Char | ISO 8601 datetime or interval | Timing | End date/time of the adverse experience represented in ISO 8601 character format. | Exp | AE | ENDTC | 54 | SDTM Events | AE |
| AESTDY | Study Day of Start of Adverse Experience | Num | Timing | Study day of start of adverse experience relative to the applicant-defined RFSTDTC. | Perm | AE | STDY | 55 | SDTM Events | AE | |
| AEENDY | Study Day of End of Adverse Experience | Num | Timing | Study day of end of experience relative to the applicant-defined RFSTDTC. | Perm | AE | ENDY | 56 | SDTM Events | AE | |
| AEDUR | Duration of Adverse Experience | Char | ISO 8601 duration | Timing | Collected duration and unit of an adverse experience. Used only if collected on the CRF and not derived from start and end date/times. Example: "P1DT2H" (for 1 day, 2 hours). | Perm | AE | DUR | 57 | SDTM Events | AE |
| AEENRF | End Relative to Reference Period | Char | (STENRF) | Timing | Describes the end of the experience relative to the applicant-defined reference period. The applicant-defined reference period is a continuous period of time defined by a discrete starting point (RFSTDTC) and a discrete ending point (RFENDTC) of the trial. | Perm | AE | ENRF | 58 | SDTM Events | AE |
| AEENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the end of the experience as being before or after the reference time point defined by variable AEENTPT. | Perm | AE | ENRTPT | 59 | SDTM Events | AE |
| AEENTPT | End Reference Time Point | Char | Timing | Description of date/time in ISO 8601-character format of the reference point referred to by AEENRTPT. Examples: "2003-12-25", "VISIT 2". | Perm | AE | ENTPT | 60 | SDTM Events | AE | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DS | STUDYID | 1 | SDTM Events | ||
| DOMAIN | Domain Abbreviation | Char | DS | Identifier | Two-character abbreviation for the domain. | Req | DS | DOMAIN | 2 | SDTM Events | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | DS | USUBJID | 3 | SDTM Events | ||
| DSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | DS | SEQ | 4 | SDTM Events | DS | |
| DSGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | DS | GRPID | 5 | SDTM Events | DS | |
| DSREFID | Reference ID | Char | Identifier | Internal or external identifier. | Perm | DS | REFID | 6 | SDTM Events | DS | |
| DSSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a Disposition page. | Perm | DS | SPID | 7 | SDTM Events | DS | |
| DSTERM | Reported Term for the Disposition Event | Char | Topic | Verbatim name of the event or protocol milestone. Some terms in DSTERM will match DSDECOD, but others, such as "Subject moved", will map to controlled terminology in DSDECOD, such as "LOST TO FOLLOW-UP". | Req | DS | TERM | 8 | SDTM Events | DS | |
| DSDECOD | Standardized Disposition Term | Char | (TNCOMPLT) \n (PROTMLST) \n (OTHEVENT) | Synonym Qualifier | Controlled terminology for the name of disposition event or protocol milestone. Examples of protocol milestones: "INFORMED CONSENT OBTAINED". There are separate codelists used for DSDECOD where the choice depends on the value of DSCAT. Codelist "NCOMPLT" is used for disposition events, codelist "PROTMLST" is used for protocol milestones, and codelist "OTHEVENT" is used for other events. | Req | DS | DECOD | 9 | SDTM Events | DS |
| DSCAT | Category for Disposition Event | Char | (DSCAT) | Grouping Qualifier | Used to define a category of related records. | Exp | DS | CAT | 10 | SDTM Events | DS |
| DSSCAT | Subcategory for Disposition Event | Char | (DSSCAT) | Grouping Qualifier | A further categorization of DSCAT (e.g., "STUDY PARTICIPATION" when DSCAT = "DISPOSITION EVENT"). The variable may be subject to controlled terminology for other categories of disposition event records. | Perm | DS | SCAT | 11 | SDTM Events | DS |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the event. | Perm | DS | EPOCH | 12 | SDTM Events | |
| DSDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of the disposition observation represented in ISO 8601 character format. | Perm | DS | DTC | 13 | SDTM Events | DS |
| DSSTDTC | Start Date/Time of Disposition Event | Char | ISO 8601 datetime or interval | Timing | Start date/time of the disposition event in ISO 8601 character format. | Exp | DS | STDTC | 14 | SDTM Events | DS |
| DSDY | Study Day of Collection | Num | Timing | Study day of collection of event relative to the applicant-defined RFSTDTC. | Perm | DS | DY | 15 | SDTM Events | DS | |
| DSSTDY | Study Day of Start of Disposition Event | Num | Timing | Study day of start of event relative to the applicant-defined RFSTDTC. | Exp | DS | STDY | 16 | SDTM Events | DS | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DV | STUDYID | 1 | SDTM Events | ||
| DOMAIN | Domain Abbreviation | Char | DV | Identifier | Two-character abbreviation for the domain. | Req | DV | DOMAIN | 2 | SDTM Events | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | DV | USUBJID | 3 | SDTM Events | ||
| DVSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | DV | SEQ | 4 | SDTM Events | DV | |
| DVREFID | Reference ID | Char | Identifier | Internal or external identifier. | Perm | DV | REFID | 5 | SDTM Events | DV | |
| DVSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF page. | Perm | DV | SPID | 6 | SDTM Events | DV | |
| DVTERM | Protocol Deviation Term | Char | Topic | Verbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". DVTERM values will map to the controlled terminology in DVDECOD (e.g., "STUDY PRODUCT ASSIGNMENT DEVIATION"). | Req | DV | TERM | 7 | SDTM Events | DV | |
| DVDECOD | Protocol Deviation Coded Term | Char | Synonym Qualifier | Controlled terminology for the name of the protocol deviation. Examples: "STUDY PRODUCT ASSIGNMENT DEVIATION", "EXCLUDED CONCOMITANT MEDICATION". | Perm | DV | DECOD | 8 | SDTM Events | DV | |
| DVCAT | Category for Protocol Deviation | Char | Grouping Qualifier | Category of the protocol deviation criterion. | Perm | DV | CAT | 9 | SDTM Events | DV | |
| DVSCAT | Subcategory for Protocol Deviation | Char | Grouping Qualifier | A further categorization of the protocol deviation. | Perm | DV | SCAT | 10 | SDTM Events | DV | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm. | Perm | DV | TAETORD | 11 | SDTM Events | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the deviation. Examples: "PRODUCT EXPOSURE", "SCREENING", "FOLLOW-UP". | Perm | DV | EPOCH | 12 | SDTM Events | |
| DVSTDTC | Start Date/Time of Deviation | Char | ISO 8601 datetime or interval | Timing | Start date/time of deviation represented in ISO 8601 character format. | Perm | DV | STDTC | 13 | SDTM Events | DV |
| DVENDTC | End Date/Time of Deviation | Char | ISO 8601 datetime or interval | Timing | End date/time of deviation represented in ISO 8601 character format. | Perm | DV | ENDTC | 14 | SDTM Events | DV |
| DVSTDY | Study Day of Start of Deviation Event | Num | Timing | Study day of start of event relative to the applicant-defined RFSTDTC. | Perm | DV | STDY | 15 | SDTM Events | DV | |
| DVENDY | Study Day of End of Deviation Event | Num | Timing | Study day of end of event relative to the applicant-defined RFSTDTC. | Perm | DV | ENDY | 16 | SDTM Events | DV | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | EM | STUDYID | 1 | SDTM Events | ||
| DOMAIN | Domain Abbreviation | Char | EM | Identifier | Two-character abbreviation for the domain. | Req | EM | DOMAIN | 2 | SDTM Events | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. \n Permissible rather than required because events may happen to or with a tobacco product device that do not involve subjects, and may even be before the tobacco product device was in contact with a subject. Should be used when the malfunction is associated with a subject's use or possession of the tobacco product device. | Perm | EM | USUBJID | 3 | SDTM Events | ||
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. | Req | EM | SPTOBID | 4 | SDTM Events | ||
| EMSEQ | Device Events Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of records. | Req | EM | SEQ | 5 | SDTM Events | EM | |
| EMSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. \n Perhaps defined in the applicant's operational database. Note that it does not have to be numeric. | Perm | EM | SPID | 6 | SDTM Events | EM | |
| EMTERM | Reported Term for Device Event | Char | Topic | Verbatim name of the observed event. \n Examples: "Battery malfunction", "Overheating". | Req | EM | TERM | 7 | SDTM Events | EM | |
| EMMODIFY | Modified Device Event Name | Char | Synonym Qualifier | The modified text for EMTERM. \n If EMTERM is modified, then the modified text is placed here. | Perm | EM | MODIFY | 8 | SDTM Events | EM | |
| EMDECOD | Device Events Dictionary-Derived Term | Char | Synonym Qualifier | Dictionary-derived text description of EMTERM or EMMODIFY. Note: CDISC does not prescribe what standardized or dictionary-derived text should be used. \n The name and version of the dictionary used to map terms must be provided to reviewers. | Perm | EM | DECOD | 9 | SDTM Events | EM | |
| EMCAT | Category of Device Event | Char | Grouping Qualifier | Used to define a categorization level for events. \n For example, "MALFUNCTION" vs. "CALIBRATION". | Perm | EM | CAT | 10 | SDTM Events | EM | |
| EMSCAT | Subcategory of Device Event | Char | Grouping Qualifier | Used to define a further category level for events. | Perm | EM | SCAT | 11 | SDTM Events | EM | |
| EMPRESP | Pre-Specified Device Event | Char | (NY) | Record Qualifier | Used to indicate whether (Y/null) information about a specific event was solicited on the CRF. \n For example, EMTERM could contain a list of malfunctions that are being specifically evaluated. EMPRESP would identify those (Y), whereas any spontaneous events would have EMPRESP null. | Perm | EM | PRESP | 12 | SDTM Events | EM |
| EMOCCUR | Device Event Occurrence | Char | (NY) | Record Qualifier | When information about specific events is solicited, EMOCCUR is used to indicate whether or not (Y/N) a particular pre-specified event occurred. \n Values are null for events not specifically solicited. | Perm | EM | OCCUR | 13 | SDTM Events | EM |
| EMSTAT | Device Event Collection Status | Char | (ND) | Record Qualifier | The status indicates that the pre-specified question was not answered. \n For example, if equipment operation requires checking, such as checking an event log to detect events. Capturing that the checks were not completed may be relevant to interpreting the study data. | Perm | EM | STAT | 14 | SDTM Events | EM |
| EMREASND | Reason Device Event Not Collected | Char | Record Qualifier | Reason EMSTAT was "NOT DONE". \n This variable should only be used if there are pre-specified events. | Perm | EM | REASND | 15 | SDTM Events | EM | |
| EMSEV | Device Event Severity | Char | Record Qualifier | Describes the severity of the event, (e.g, the severity of a malfunction). | Perm | EM | SEV | 16 | SDTM Events | EM | |
| EMACNDEV | Action Taken with Device | Char | Record Qualifier | Describes action taken with respect to the tobacco product device. \n Action Taken may include tobacco product device replacement, battery replacement, etc. | Perm | EM | ACNDEV | 17 | SDTM Events | EM | |
| EMPATT | Pattern of Device Event | Char | Record Qualifier | A characterization of the temporal pattern of occurrences of the tobacco product device event or malfunction. | Perm | EM | PATT | 18 | SDTM Events | EM | |
| VISITNUM | Visit Number | Num | Timing | Clinical encounter number. \n Numeric version of VISIT, used for sorting. | Perm | EM | VISITNUM | 19 | SDTM Events | ||
| VISIT | Visit Name | Char | Timing | Protocol-defined description of clinical encounter. \n May be used in addition to VISITNUM and/or VISITDY. | Perm | EM | VISIT | 20 | SDTM Events | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. \n This value is usually derived. | Perm | EM | VISITDY | 21 | SDTM Events | ||
| EMDTC | Date of Device Event Data Collection | Char | ISO 8601 datetime or interval | Timing | Date the tobacco product device event information was collected. \n This may be reported if the event (e.g., malfunction) is discovered on a different date from the event. | Perm | EM | DTC | 22 | SDTM Events | EM |
| EMSTDTC | Start Date/Time of Device Event | Char | ISO 8601 datetime or interval | Timing | Start date/time of the tobacco product device event. \n If the event happened at a single point in time, EMSTDTC is used. | Perm | EM | STDTC | 23 | SDTM Events | EM |
| EMENDTC | End Date/Time of Device Event | Char | ISO 8601 datetime or interval | Timing | End date/time of the tobacco product device event. \n If an event lasted over a period of time, EMENDTC can be used to capture the end date/time. | Perm | EM | ENDTC | 24 | SDTM Events | EM |
| EMDY | Study Day of Start of Tracking Event | Num | Timing | Study day of tobacco product device event observation, measured as integer days. \n Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | EM | DY | 25 | SDTM Events | EM | |
| EMSTDY | Study Day of Device Event Start | Num | Timing | Study day of start of tobacco product device event, measured as integer days. \n Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | EM | STDY | 26 | SDTM Events | EM | |
| EMENDY | Study Day of Device Event End | Num | Timing | Study day of end of tobacco product device event, measured as integer days. \n Algorithm for calculations must be relative to the applicant-defined RFENDTC variable in Demographics. | Perm | EM | ENDY | 27 | SDTM Events | EM | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | MH | STUDYID | 1 | SDTM Events | ||
| DOMAIN | Domain Abbreviation | Char | MH | Identifier | Two-character abbreviation for the domain. | Req | MH | DOMAIN | 2 | SDTM Events | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | MH | USUBJID | 3 | SDTM Events | ||
| MHSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | MH | SEQ | 4 | SDTM Events | MH | |
| MHGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | MH | GRPID | 5 | SDTM Events | MH | |
| MHREFID | Reference ID | Char | Identifier | Internal or external medical history identifier. | Perm | MH | REFID | 6 | SDTM Events | MH | |
| MHSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a Medical History CRF page. | Perm | MH | SPID | 7 | SDTM Events | MH | |
| MHTERM | Reported Term for the Medical History | Char | Topic | Verbatim or preprinted CRF term for the medical condition or event. | Req | MH | TERM | 8 | SDTM Events | MH | |
| MHMODIFY | Modified Reported Term | Char | Synonym Qualifier | If MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text. | Perm | MH | MODIFY | 9 | SDTM Events | MH | |
| MHDECOD | Dictionary-Derived Term | Char | Synonym Qualifier | Dictionary-derived text description of MHTERM or MHMODIFY. Equivalent to the Preferred Term (PT in MedDRA). | Perm | MH | DECOD | 10 | SDTM Events | MH | |
| MHEVDTYP | Medical History Event Date Type | Char | (MHEDTTYP) | Variable Qualifier | Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. Examples: "DIAGNOSIS", "SYMPTOMS", "RELAPSE", "INFECTION". | Perm | MH | EVDTYP | 11 | SDTM Events | MH |
| MHCAT | Category for Medical History | Char | Grouping Qualifier | Used to define a category of related records. Examples: "CARDIAC", "GENERAL". | Perm | MH | CAT | 12 | SDTM Events | MH | |
| MHSCAT | Subcategory for Medical History | Char | Grouping Qualifier | A further categorization of the condition or event. | Perm | MH | SCAT | 13 | SDTM Events | MH | |
| MHPRESP | Medical History Event Pre-Specified | Char | (NY) | Variable Qualifier | A value of "Y" indicates that this medical history event was prespecified on the CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms). | Perm | MH | PRESP | 14 | SDTM Events | MH |
| MHOCCUR | Medical History Occurrence | Char | (NY) | Record Qualifier | Used when the occurrence of specific medical history conditions is solicited, to indicate whether ("Y"/"N") a medical condition (MHTERM) had ever occurred. Values are null for spontaneously reported events. | Perm | MH | OCCUR | 15 | SDTM Events | MH |
| MHSTAT | Completion Status | Char | (ND) | Record Qualifier | The status indicates that the prespecified question was not asked/answered. | Perm | MH | STAT | 16 | SDTM Events | MH |
| MHREASND | Reason Medical History Not Collected | Char | Record Qualifier | Describes the reason why data for a prespecified condition was not collected. Used in conjunction with MHSTAT when value is "NOT DONE". | Perm | MH | REASND | 17 | SDTM Events | MH | |
| MHBODSYS | Body System or Organ Class | Char | Record Qualifier | Dictionary-derived. Body system or organ class that is involved in an event or measurement from a standard hierarchy (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the applicant's analyses and summary tables which may not necessarily be the primary SOC. | Perm | MH | BODSYS | 18 | SDTM Events | MH | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm for the element in which the assessment was made. | Perm | MH | TAETORD | 19 | SDTM Events | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the medical history event. | Perm | MH | EPOCH | 20 | SDTM Events | |
| MHDTC | Date/Time of History Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of the medical history observation represented in ISO 8601 character format. | Perm | MH | DTC | 21 | SDTM Events | MH |
| MHSTDTC | Start Date/Time of Medical History Event | Char | ISO 8601 datetime or interval | Timing | Start date/time of the medical history event represented in ISO 8601 character format. | Perm | MH | STDTC | 22 | SDTM Events | MH |
| MHENDTC | End Date/Time of Medical History Event | Char | ISO 8601 datetime or interval | Timing | End date/time of the medical history event. | Perm | MH | ENDTC | 23 | SDTM Events | MH |
| MHDY | Study Day of History Collection | Num | Timing | Study day of medical history collection, measured as integer day. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. | Perm | MH | DY | 24 | SDTM Events | MH | |
| MHENRF | End Relative to Reference Period | Char | (STENRF) | Timing | Describes the end of the event relative to the applicant-defined reference period. The appilcant-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). | Perm | MH | ENRF | 25 | SDTM Events | MH |
| MHENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the end of the event as being before or after the reference time point defined by variable MHENTPT. | Perm | MH | ENRTPT | 26 | SDTM Events | MH |
| MHENTPT | End Reference Time Point | Char | Timing | Description or date/time in ISO 8601 character format of the reference point referred to by MHENRTPT. Examples: "2003-12-25", "VISIT 2". | Perm | MH | ENTPT | 27 | SDTM Events | MH | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | FA | STUDYID | 1 | SDTM Findings About | ||
| DOMAIN | Domain Abbreviation | Char | FA | Identifier | Two-character abbreviation for the domain. | Req | FA | DOMAIN | 2 | SDTM Findings About | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | FA | USUBJID | 3 | SDTM Findings About | ||
| FASEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | FA | SEQ | 4 | SDTM Findings About | FA | |
| FAGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | FA | GRPID | 5 | SDTM Findings About | FA | |
| FASPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF. | Perm | FA | SPID | 6 | SDTM Findings About | FA | |
| FATESTCD | Findings About Test Short Name | Char | (FATESTCD) | Topic | Short name of the measurement, test, or examination described in FATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FATESTCD cannot contain characters other than letters, numbers, or underscores. Example: "OCCUR". Note that controlled terminology is in a FATESTCD general codelist and in several therapeutic area-specific codelists. | Req | FA | TESTCD | 7 | SDTM Findings About | FA |
| FATEST | Findings About Test Name | Char | (FATEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in FATEST cannot be longer than 40 characters. Example:"Occurrence". Note that controlled terminology is in a FATEST general codelist and in several therapeutic area-specific codelists. | Req | FA | TEST | 8 | SDTM Findings About | FA |
| FAOBJ | Object of the Observation | Char | Record Qualifier | Used to describe the object or focal point of the findings observation that is represented by --TEST. Examples: the term (e.g., "Acne") describing a clinical sign or symptom that is being measured by a severity test; an event (e.g., "VOMIT, where the volume of vomit is being measured by a VOLUME test). | Req | FA | OBJ | 9 | SDTM Findings About | FA | |
| FACAT | Category for Findings About | Char | Grouping Qualifier | Used to define a category of related records. Examples: "GERD", "PRE-SPECIFIED AE". | Perm | FA | CAT | 10 | SDTM Findings About | FA | |
| FASCAT | Subcategory for Findings About | Char | Grouping Qualifier | A further categorization of FACAT. | Perm | FA | SCAT | 11 | SDTM Findings About | FA | |
| FAORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the test as originally received or collected. | Exp | FA | ORRES | 12 | SDTM Findings About | FA | |
| FAORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for FAORRES. | Perm | FA | ORRESU | 13 | SDTM Findings About | FA |
| FASTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from FAORRES in a standard format or standard units. FASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in FASTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in FAORRES, and these results effectively have the same meaning; they could be represented in standard format in FASTRESC as "NEGATIVE". | Exp | FA | STRESC | 14 | SDTM Findings About | FA | |
| FASTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from FASTRESC. FASTRESN should store all numeric test results or findings. | Perm | FA | STRESN | 15 | SDTM Findings About | FA | |
| FASTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for FASTRESC and FASTRESN. | Perm | FA | STRESU | 16 | SDTM Findings About | FA |
| FASTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that the measurement was not done. Should be null if a result exists in FAORRES. | Perm | FA | STAT | 17 | SDTM Findings About | FA |
| FAREASND | Reason Not Performed | Char | Record Qualifier | Describes why a question was not answered. Example: "Subject refused". Used in conjunction with FASTAT when value is "NOT DONE". | Perm | FA | REASND | 18 | SDTM Findings About | FA | |
| FALOC | Location of the Finding About | Char | (LOC) | Record Qualifier | Used to specify the location of the clinical evaluation. Example: "ARM". | Perm | FA | LOC | 19 | SDTM Findings About | FA |
| FALAT | Laterality | Char | (LAT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". | Perm | FA | LAT | 20 | SDTM Findings About | FA |
| FALOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. | Perm | FA | LOBXFL | 21 | SDTM Findings About | FA |
| FAEVAL | Evaluator | Char | (EVAL) | Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR". | Perm | FA | EVAL | 22 | SDTM Findings About | FA |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | FA | VISITNUM | 23 | SDTM Findings About | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | FA | VISIT | 24 | SDTM Findings About | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | FA | VISITDY | 25 | SDTM Findings About | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm. | Perm | FA | TAETORD | 26 | SDTM Findings About | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the date/time of the observation. Examples: "SCREENING", "PRODUCT EXPOSURE", "FOLLOW-UP". | Perm | FA | EPOCH | 27 | SDTM Findings About | |
| FADTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of findings assessment represented in ISO 8601 character format. | Exp | FA | DTC | 28 | SDTM Findings About | FA |
| FADY | Study Day of Collection | Num | Timing | Study day of collection, measured as integer days.Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. | Perm | FA | DY | 29 | SDTM Findings About | FA | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study within the submission. | Req | DA | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | DA | Identifier | Two-character abbreviation for the domain. | Req | DA | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Unique subject identifier within the submission. | Req | DA | USUBJID | 3 | SDTM Findings | ||
| DASEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | DA | SEQ | 4 | SDTM Findings | DA | |
| DAGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | DA | GRPID | 5 | SDTM Findings | DA | |
| DAREFID | Reference ID | Char | Identifier | Internal or external identifier such as label number. | Perm | DA | REFID | 6 | SDTM Findings | DA | |
| DASPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Examples: Line number on the Product Accountability page, product label code. | Perm | DA | SPID | 7 | SDTM Findings | DA | |
| DATESTCD | Short Name of Accountability Assessment | Char | (DATESTCD) | Topic | Short character value for DATEST 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 and cannot begin with a number or contain characters other than letters, numbers, or underscores. Example: "DISPAMT", "RETAMT". | Req | DA | TESTCD | 8 | SDTM Findings | DA |
| DATEST | Name of Accountability Assessment | Char | (DATEST) | Synonym Qualifier | Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the product accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: "Dispensed Amount", "Returned Amount". | Req | DA | TEST | 9 | SDTM Findings | DA |
| DACAT | Category | Char | Grouping Qualifier | Used to define a category of topic-variable values (e.g., "STUDY PRODUCT).. | Perm | DA | CAT | 10 | SDTM Findings | DA | |
| DASCAT | Subcategory | Char | Grouping Qualifier | Used to define a further categorization level for a group of related records. | Perm | DA | SCAT | 11 | SDTM Findings | DA | |
| DAORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the Product Accountability assessment as originally received or collected. | Exp | DA | ORRES | 12 | SDTM Findings | DA | |
| DAORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Unit for DAORRES. | Perm | DA | ORRESU | 13 | SDTM Findings | DA |
| DASTRESC | Result or Finding in Standard Format | Char | Result Qualifier | Contains the result value for all Product Accountability assessments, copied or derived from DAORRES in a standard format or in standard units. DASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DASTRESN. | Exp | DA | STRESC | 14 | SDTM Findings | DA | |
| DASTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from DASTRESC. DASTRESN should store all numeric test results or findings. | Perm | DA | STRESN | 15 | SDTM Findings | DA | |
| DASTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized units used for DASTRESC and DASTRESN. | Perm | DA | STRESU | 16 | SDTM Findings | DA |
| DASTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a product accountability assessment was not done. Should be null or have a value of "NOT DONE". | Perm | DA | STAT | 17 | SDTM Findings | DA |
| DAREASND | Reason Not Done | Char | Record Qualifier | Reason not done. Used in conjunction with DASTAT when value is "NOT DONE". | Perm | DA | REASND | 18 | SDTM Findings | DA | |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | DA | VISITNUM | 19 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | DA | VISIT | 20 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit, based upon RFSTDTC in Demographics. | Perm | DA | VISITDY | 21 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | DA | TAETORD | 22 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. | Perm | DA | EPOCH | 23 | SDTM Findings | |
| DADTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date and time of the product accountability assessment represented in ISO 8601 character format. | Exp | DA | DTC | 24 | SDTM Findings | DA |
| DADY | Study Day of Visit/Collection/Exam | Num | Timing | Study day of product accountability assessment, measured in integer days.Algorithm for calculations must be relative to the applicant-defined RFSTDTC in Demographics. | Perm | DA | DY | 25 | SDTM Findings | DA | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DO | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | DO | Identifier | Two-character abbreviation for the domain. | Req | DO | MAIN | 2 | SDTM Findings | DO |
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for the device. \n It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers). | Req | DO | SPDEVID | 3 | SDTM Findings | ||
| DOSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of device records within subject records within a domain. \n May be any valid number. It should be unique within every subject/device combination. | Req | DO | SEQ | 4 | SDTM Findings | DO | |
| DOGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a device. | Perm | DO | GRPID | 5 | SDTM Findings | DO | |
| DOREFID | Reference ID | Char | Identifier | Internal or external identifier. \n This could be a scan code or equivalent. | Perm | DO | REFID | 6 | SDTM Findings | DO | |
| DOSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. | Perm | DO | SPID | 7 | SDTM Findings | DO | |
| DOTESTCD | Device Property Short Name | Char | (DOTESTCD) | Topic | Short name of the measurement, test, or examination described in DOTEST. \n It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DOTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DOTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SHLFLIFE", "INDC", "COMPOS". | Req | DO | TESTCD | 8 | SDTM Findings | DO |
| DOTEST | Device Property Test Name | Char | (DOTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. \n The value in DOTEST cannot be longer than 40 characters. Examples: "Shelf Life", "Indication for use", "Composition" (of device). | Req | DO | TEST | 9 | SDTM Findings | DO |
| DOCAT | Category for Device In-Use | Char | Grouping Qualifier | Defines a category of related records. \n For example, it can be used to define the type of property being defined, such as "DIMENSIONS" versus "MATERIAL". | Perm | DO | CAT | 10 | SDTM Findings | DO | |
| DOSCAT | Subcategory for Device In-Use | Char | Grouping Qualifier | A further categorization of a measurement or examination. \n For example, if DOCAT = "DIMENSION", DOSCAT might be "LENGTH" or "WIDTH" or "THICKNESS". | Perm | DO | SCAT | 11 | SDTM Findings | DO | |
| DOORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the Device Property as originally observed or collected. \n DOORRES should contain the result or value of the property defined in DOTEST. For example, if DOTEST is LIFE (shelf life), then DOORRES might be 6 (months). | Exp | DO | ORRES | 12 | SDTM Findings | DO | |
| DOORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. \n The unit for DOORRES. Examples: "MONTHS", "cm". | Exp | DO | ORRESU | 13 | SDTM Findings | DO |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DU | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | DU | Identifier | Two-character abbreviation for the domain. | Req | DU | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. \n Expected in this domain as devices may have settings or uses that either may not involve subjects (e.g., diagnostic tools) or devices that are removed from the study prior to contact with a subject (e.g., device has malfunction). | Exp | DU | USUBJID | 3 | SDTM Findings | ||
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for the device. \n It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, or combination of identifiers). | Exp | DU | SPDEVID | 4 | SDTM Findings | ||
| DUSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of device records within subject records within a domain. \n May be any valid number. It should be unique within every subject/device combination. | Req | DU | SEQ | 5 | SDTM Findings | DU | |
| DUGRPID | Group ID | Char | Identifier | Identifier for a group or block of related records. \n Used to tie together a block of related records in a single domain for a subject or a group of subject related records (e.g., group records specifying all the settings for a specific imaging scan, such as field strength, repetition time and echo time). | Perm | DU | GRPID | 6 | SDTM Findings | DU | |
| DUREFID | Reference ID | Char | Identifier | Internal or external identifier. \n This could be a scan code or equivalent. | Perm | DU | REFID | 7 | SDTM Findings | DU | |
| DUSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. \n Perhaps pre-printed on the CRF as an explicit line identifier or defined in the applicant's operational database. | Perm | DU | SPID | 8 | SDTM Findings | DU | |
| DUTESTCD | Device-In-Use Test Short Name | Char | (DUTESTCD) | Topic | Short name of the measurement, test, or examination described in DUTEST. \n It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DUTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DUTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "COILSTR", "CNTMEDIA". | Req | DU | TESTCD | 9 | SDTM Findings | DU |
| DUTEST | Device-In-Use Test Name | Char | (DUTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. \n The value in DUTEST cannot be longer than 40 characters. Examples: "Coil Strength", "Contrast Media". | Req | DU | TEST | 10 | SDTM Findings | DU |
| DUCAT | Category for Device-In-Use | Char | Grouping Qualifier | Defines a category of related records. \n It can be used to define the type of device for which settings are recorded if the DI domain is not used (e.g., if the device is not under study); may also be used to record the type of setting (e.g., "HARDWARE" vs. "SOFTWARE"). | Perm | DU | CAT | 11 | SDTM Findings | DU | |
| DUSCAT | Subcategory for Device-In-Use | Char | Grouping Qualifier | A further categorization of a measurement or examination. \n For example, if DUCAT = "SOFTWARE", DUSCAT might be "NOMINAL" or "POST-ADJUSTMENT". | Perm | DU | SCAT | 12 | SDTM Findings | DU | |
| DUORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement as originally received or collected. \n DUORRES should contain the setting or other device condition in effect at the time the device was used. | Exp | DU | ORRES | 13 | SDTM Findings | DU | |
| DUORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. \n The unit for DUORRES. Examples: Tesla, mm. | Exp | DU | ORRESU | 14 | SDTM Findings | DU |
| DUSTRESC | Result or Finding in Standard Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from DUORRES in a standard format or standard units. \n DUSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DUSTRESN. For example, if a test has results "NONE," "NEG," and "NEGATIVE" in DUORRES, and these results effectively have the same meaning, they could be represented in standard format in DUSTRESC as "NEGATIVE". | Exp | DU | STRESC | 15 | SDTM Findings | DU | |
| DUSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format. \n Copied in numeric format from DUSTRESC. DUSTRESN should store all numeric test results or findings. | Exp | DU | STRESN | 16 | SDTM Findings | DU | |
| DUSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for DUSTRESC and DUSTRESN. \n The unit for standardized results may or may not be the same as for the original results. | Exp | DU | STRESU | 17 | SDTM Findings | DU |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | DU | VISITNUM | 18 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | DU | VISIT | 19 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. \n This value is usually derived. | Perm | DU | VISITDY | 20 | SDTM Findings | ||
| DUDTC | Date/Time Device Used with Test/Setting | Char | ISO 8601 datetime or interval | Timing | Date/time that the device was used with this setting. \n This is not the date/time that the setting was set on the device, but rather that date/time that a measurement or test was done using that setting. | Exp | DU | DTC | 21 | SDTM Findings | DU |
| DUDY | Study Day of Observation | Num | Timing | Study day of Device-In-Use measurement, measured as integer days. \n Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | DU | DY | 22 | SDTM Findings | DU | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | EG | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | EG | Identifier | Two-character abbreviation for the domain. | Req | EG | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | EG | USUBJID | 3 | SDTM Findings | ||
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for a device. | Perm | EG | SPDEVID | 4 | SDTM Findings | ||
| EGSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | EG | SEQ | 5 | SDTM Findings | EG | |
| EGGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | EG | GRPID | 6 | SDTM Findings | EG | |
| EGREFID | ECG Reference ID | Char | Identifier | Internal or external ECG identifier. Example: "UUID". | Perm | EG | REFID | 7 | SDTM Findings | EG | |
| EGSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number from the ECG page. | Perm | EG | SPID | 8 | SDTM Findings | EG | |
| EGBEATNO | ECG Beat Number | Num | Variable Qualifier | A sequence number that identifies the beat within an ECG. | Perm | EG | BEATNO | 9 | SDTM Findings | EG | |
| EGTESTCD | ECG Test or Examination Short Name | Char | (EGTESTCD) \n (HETESTCD) | Topic | Short name of the measurement, test, or examination described in EGTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in EGTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). EGTESTCD cannot contain characters other than letters, numbers, or underscores. Examples : "PRAG", "QRSAG". \n Test codes are in two separate codelists, one for tests based on regular 10-second ECGs (EGTESTCD) and one for tests based on Holter monitoring (HETESTCD). | Req | EG | TESTCD | 10 | SDTM Findings | EG |
| EGTEST | ECG Test or Examination Name | Char | (EGTEST) \n (HETEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in EGTEST cannot be longer than 40 characters. Examples: "PR Interval, Aggregate", "QRS Duration, Aggregate". \n Test names are in two separate codelists, one for tests based on regular 10-second ECGs (EGTEST) and one for tests based on Holter monitoring (HETEST). | Req | EG | TEST | 11 | SDTM Findings | EG |
| EGCAT | Category for ECG | Char | Grouping Qualifier | Used to categorize ECG observations across subjects. Examples: "MEASUREMENT", "FINDING", "INTERVAL". | Perm | EG | CAT | 12 | SDTM Findings | EG | |
| EGSCAT | Subcategory for ECG | Char | Grouping Qualifier | A further categorization of the ECG. | Perm | EG | SCAT | 13 | SDTM Findings | EG | |
| EGPOS | ECG Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". | Perm | EG | POS | 14 | SDTM Findings | EG |
| EGORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the ECG measurement or finding as originally received or collected. Examples of expected values are "62" or "0.151" when the result is an interval or measurement, or "ATRIAL FIBRILLATION" or "QT PROLONGATION" when the result is a finding. | Exp | EG | ORRES | 15 | SDTM Findings | EG | |
| EGORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for EGORRES. Examples: "sec" or "msec". | Perm | EG | ORRESU | 16 | SDTM Findings | EG |
| EGSTRESC | Character Result/Finding in Std Format | Char | (EGSTRESC) \n (HESTRESC) | Result Qualifier | Contains the result value for all findings, copied or derived from EGORRES in a standard format or standard units. EGSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in EGSTRESN. For example, if a test has results of "NONE", "NEG", and "NEGATIVE" in EGORRES and these results effectively have the same meaning, they could be represented in standard format in EGSTRESC as "NEGATIVE". For other examples, see general assumptions. Additional examples of result data: "SINUS BRADYCARDIA", "ATRIAL FLUTTER", "ATRIAL FIBRILLATION". \n Test results are in two separate codelists, one for tests based on regular 10-second ECGs (EGSTRESC) and one for tests based on Holter monitoring (HESTRESC). | Exp | EG | STRESC | 17 | SDTM Findings | EG |
| EGSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from EGSTRESC. EGSTRESN should store all numeric test results or findings. | Perm | EG | STRESN | 18 | SDTM Findings | EG | |
| EGSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized units used for EGSTRESC and EGSTRESN. | Perm | EG | STRESU | 19 | SDTM Findings | EG |
| EGSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate an ECG was not done, or an ECG measurement was not taken. Should be null if a result exists in EGORRES. | Perm | EG | STAT | 20 | SDTM Findings | EG |
| EGREASND | Reason ECG Not Done | Char | Record Qualifier | Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED". Used in conjunction with EGSTAT when value is "NOT DONE". | Perm | EG | REASND | 21 | SDTM Findings | EG | |
| EGXFN | ECG External File Path | Char | Record Qualifier | File name and path for the external ECG waveform file. | Perm | EG | XFN | 22 | SDTM Findings | EG | |
| EGNAM | Vendor Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor who provided the test results. | Perm | EG | NAM | 23 | SDTM Findings | EG | |
| EGMETHOD | Method of Test or Examination | Char | (EGMETHOD) | Record Qualifier | Method of the ECG test. Example: "12 LEAD STANDARD". | Perm | EG | METHOD | 24 | SDTM Findings | EG |
| EGLEAD | Lead Location Used for Measurement | Char | (EGLEAD) | Record Qualifier | The lead used for the measurement. Examples: "LEAD 1", "LEAD 2", "LEAD 3", "LEAD rV2", "LEAD V1". | Perm | EG | LEAD | 25 | SDTM Findings | EG |
| EGLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. | Exp | EG | LOBXFL | 26 | SDTM Findings | EG |
| EGEVAL | Evaluator | Char | (EVAL) | Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR". | Perm | EG | EVAL | 27 | SDTM Findings | EG |
| EGEVALID | Evaluator Identifier | Char | (MEDEVAL) | Variable Qualifier | Used to distinguish multiple evaluators with the same role recorded in EGEVAL. Examples: "RADIOLOGIST 1" or "RADIOLOGIST 2". | Perm | EG | EVALID | 28 | SDTM Findings | EG |
| EGREPNUM | Repetition Number | Num | Record Qualifier | The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of blood pressure or multiple analyses of a sample. | Perm | EG | REPNUM | 29 | SDTM Findings | EG | |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | EG | VISITNUM | 30 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | EG | VISIT | 31 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | EG | VISITDY | 32 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm for the element in which the assessment was made. | Perm | EG | TAETORD | 33 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the date/time at which the assessment was made. | Perm | EG | EPOCH | 34 | SDTM Findings | |
| EGDTC | Date/Time of ECG | Char | ISO 8601 datetime or interval | Timing | Date/Time of ECG. | Exp | EG | DTC | 35 | SDTM Findings | EG |
| EGDY | Study Day of ECG | Num | Timing | Study day of the ECG, measured as integer days.Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | EG | DY | 36 | SDTM Findings | EG | |
| EGTPT | Planned Time Point Name | Char | Timing | Text description of time when measurement should be taken.This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EGTPTNUM and EGTPTREF. Examples: "Start", "5 min post". | Perm | EG | TPT | 37 | SDTM Findings | EG | |
| EGTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EGTPT to aid in sorting. | Perm | EG | TPTNUM | 38 | SDTM Findings | EG | |
| EGELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601) relative to a fixed time point reference (EGTPTREF). Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by EGTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by EGTPTREF. | Perm | EG | ELTM | 39 | SDTM Findings | EG |
| EGTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EGELTM, EGTPTNUM, and EGTPT. | Perm | EG | TPTREF | 40 | SDTM Findings | EG | |
| EGRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time for a fixed reference time point defined by EGTPTREF. | Perm | EG | RFTDTC | 41 | SDTM Findings | EG |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | IE | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | IE | Identifier | Two-character abbreviation for the domain. | Req | IE | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | IE | USUBJID | 3 | SDTM Findings | ||
| IESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | IE | SEQ | 4 | SDTM Findings | IE | |
| IESPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Inclusion or Exclusion criteria number from CRF. | Perm | IE | SPID | 5 | SDTM Findings | IE | |
| IETESTCD | Inclusion/Exclusion Criterion Short Name | Char | Topic | Short name of the criterion described in IETEST. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "IN01", "EX01". | Req | IE | TESTCD | 6 | SDTM Findings | IE | |
| IETEST | Inclusion/Exclusion Criterion | Char | Synonym Qualifier | Verbatim description of the inclusion or exclusion criterion that was the exception for the subject within the study. IETEST cannot be longer than 200 characters. | Req | IE | TEST | 7 | SDTM Findings | IE | |
| IECAT | Inclusion/Exclusion Category | Char | (IECAT) | Grouping Qualifier | Used to define a category of related records across subjects. | Req | IE | CAT | 8 | SDTM Findings | IE |
| IESCAT | Inclusion/Exclusion Subcategory | Char | Grouping Qualifier | A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or for to categorize as a major or minor exceptions. Examples: "MAJOR", "MINOR". | Perm | IE | SCAT | 9 | SDTM Findings | IE | |
| IEORRES | I/E Criterion Original Result | Char | (NY) | Result Qualifier | Original response to Inclusion/Exclusion Criterion question, i.e., whether the inclusion or exclusion criterion was met. | Req | IE | ORRES | 10 | SDTM Findings | IE |
| IESTRESC | I/E Criterion Result in Std Format | Char | (NY) | Result Qualifier | Response to Inclusion/Exclusion criterion result in standard format. | Req | IE | STRESC | 11 | SDTM Findings | IE |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Perm | IE | VISITNUM | 12 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | IE | VISIT | 13 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | IE | VISITDY | 14 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. | Perm | IE | TAETORD | 15 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the observation date/time of the inclusion/exclusion finding. | Perm | IE | EPOCH | 16 | SDTM Findings | |
| IEDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of the inclusion/exclusion criterion represented in ISO 8601 character format. | Perm | IE | DTC | 17 | SDTM Findings | IE |
| IEDY | Study Day of Collection | Num | Timing | Study day of collection of the inclusion/exclusion exceptions, measured as integer days.Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. | Perm | IE | DY | 18 | SDTM Findings | IE | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | LB | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | LB | Identifier | Two-character abbreviation for the domain. | Req | LB | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | LB | USUBJID | 3 | SDTM Findings | ||
| LBSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | LB | SEQ | 4 | SDTM Findings | LB | |
| LBGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | LB | GRPID | 5 | SDTM Findings | LB | |
| LBREFID | Specimen ID | Char | Identifier | Internal or external specimen identifier. Example: Specimen ID. | Perm | LB | REFID | 6 | SDTM Findings | LB | |
| LBSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on the Lab page. | Perm | LB | SPID | 7 | SDTM Findings | LB | |
| LBTESTCD | Lab Test or Examination Short Name. | Char | (LBTESTCD) | Topic | Short name of the measurement, test, or examination described in LBTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in LBTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). LBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "ALT", "LDH". | Req | LB | TESTCD | 8 | SDTM Findings | LB |
| LBTEST | Lab Test or Examination Name | Char | (LBTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. Note any test normally performed by a clinical laboratory is considered a lab test. The value in LBTEST cannot be longer than 40 characters. Examples: "Alanine Aminotransferase", "Lactate Dehydrogenase". | Req | LB | TEST | 9 | SDTM Findings | LB |
| LBCAT | Category for Lab Test | Char | Grouping Qualifier | Used to define a category of related records across subjects. Examples: "HEMATOLOGY", "URINALYSIS", "CHEMISTRY". | Exp | LB | CAT | 10 | SDTM Findings | LB | |
| LBSCAT | Subcategory for Lab Test | Char | Grouping Qualifier | A further categorization of a test category such as "DIFFERENTIAL", "COAGULATION", "LIVER FUNCTION", "ELECTROLYTES". | Perm | LB | SCAT | 11 | SDTM Findings | LB | |
| LBORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | LB | ORRES | 12 | SDTM Findings | LB | |
| LBORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for LBORRES. Example: "g/L". | Exp | LB | ORRESU | 13 | SDTM Findings | LB |
| LBORNRLO | Reference Range Lower Limit in Orig Unit | Char | Variable Qualifier | Lower end of reference range for continuous measurement in original units. Should be populated only for continuous results. | Exp | LB | ORNRLO | 14 | SDTM Findings | LB | |
| LBORNRHI | Reference Range Upper Limit in Orig Unit | Char | Variable Qualifier | Upper end of reference range for continuous measurement in original units. Should be populated only for continuous results. | Exp | LB | ORNRHI | 15 | SDTM Findings | LB | |
| LBSTRESC | Character Result/Finding in Std Format | Char | (LBSTRESC) | Result Qualifier | Contains the result value for all findings, copied or derived from LBORRES in a standard format or standard units. LBSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in LBSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in LBORRES and these results effectively have the same meaning, they could be represented in standard format in LBSTRESC as "NEGATIVE". For other examples, see general assumptions. | Exp | LB | STRESC | 16 | SDTM Findings | LB |
| LBSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from LBSTRESC. LBSTRESN should store all numeric test results or findings. | Exp | LB | STRESN | 17 | SDTM Findings | LB | |
| LBSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for LBSTRESC or LBSTRESN. | Exp | LB | STRESU | 18 | SDTM Findings | LB |
| LBSTNRLO | Reference Range Lower Limit-Std Units | Num | Variable Qualifier | Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. | Exp | LB | STNRLO | 19 | SDTM Findings | LB | |
| LBSTNRHI | Reference Range Upper Limit-Std Units | Num | Variable Qualifier | Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Exp | LB | STNRHI | 20 | SDTM Findings | LB | |
| LBSTNRC | Reference Range for Char Rslt-Std Units | Char | Variable Qualifier | For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). | Perm | LB | STNRC | 21 | SDTM Findings | LB | |
| LBSTREFC | Reference Result in Standard Format | Char | Variable Qualifier | Reference value for the result or finding copied or derived from LBORREF in a standard format. | Exp | LB | STREFC | 22 | SDTM Findings | LB | |
| LBNRIND | Reference Range Indicator | Char | (NRIND) | Variable Qualifier | 1. Indicates where the value falls with respect to reference range defined by LBORNRLO and LBORNRHI, LBSTNRLO and LBSTNRHI, or by LBSTNRC. Examples: "NORMAL", "ABNORMAL", "HIGH", "LOW". \n 2. Should not be used to indicate clinical significance. | Exp | LB | NRIND | 23 | SDTM Findings | LB |
| LBSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate exam not done. Should be null if a result exists in LBORRES. | Perm | LB | STAT | 24 | SDTM Findings | LB |
| LBREASND | Reason Test Not Done | Char | Record Qualifier | Describes why a measurement or test was not performed, e.g., "BROKEN EQUIPMENT", "SUBJECT REFUSED", or "SPECIMEN LOST". Used in conjunction with LBSTAT when value is "NOT DONE". | Perm | LB | REASND | 25 | SDTM Findings | LB | |
| LBNAM | Vendor Name | Char | Record Qualifier | The name or identifier of the laboratory that performed the test. | Perm | LB | NAM | 26 | SDTM Findings | LB | |
| LBLOINC | LOINC Code | Char | Synonym Qualifier | Code for the lab test from the LOINC code system. | Perm | LB | LOINC | 27 | SDTM Findings | LB | |
| LBSPEC | Specimen Type | Char | (SPECTYPE) | Record Qualifier | Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE", "DNA", "RNA". | Perm | LB | SPEC | 28 | SDTM Findings | LB |
| LBSPCCND | Specimen Condition | Char | (SPECCOND) | Record Qualifier | Free or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC". | Perm | LB | SPCCND | 29 | SDTM Findings | LB |
| LBMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method of the test or examination. Examples: "EIA" (Enzyme Immunoassay), "ELECTROPHORESIS", "DIPSTICK". | Perm | LB | METHOD | 30 | SDTM Findings | LB |
| LBLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. | Exp | LB | LOBXFL | 31 | SDTM Findings | LB |
| LBFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status such as "Y", "N", "U", or null if not relevant. | Perm | LB | FAST | 32 | SDTM Findings | LB |
| LBTOX | Toxicity | Char | Variable Qualifier | Description of toxicity quantified by LBTOXGR. | Perm | LB | TOX | 33 | SDTM Findings | LB | |
| LBTOXGR | Standard Toxicity Grade | Char | Record Qualifier | Records toxicity grade value using a standard toxicity scale (such as the NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not "Grade 2"). | Perm | LB | TOXGR | 34 | SDTM Findings | LB | |
| LBLLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units. | Perm | LB | LLOQ | 35 | SDTM Findings | LB | |
| LBULOQ | Upper Limit of Quantitation | Num | Variable Qualifier | The highest threshold for reliably detecting the result of a specific test in standardized units. | Perm | LB | ULOQ | 36 | SDTM Findings | LB | |
| VISITNUM | Visit Number | Num | Timing | An assigned numeric identifier that aligns to the chronological order of an encounter.Numeric version of VISIT, used for sorting. | Exp | LB | VISITNUM | 37 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | LB | VISIT | 38 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | LB | VISITDY | 39 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | LB | TAETORD | 40 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. | Perm | LB | EPOCH | 41 | SDTM Findings | |
| LBDTC | Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/time of specimen collection represented in ISO 8601 character format. | Exp | LB | DTC | 42 | SDTM Findings | LB |
| LBENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | End date/time of specimen collection represented in ISO 8601 character format. | Perm | LB | ENDTC | 43 | SDTM Findings | LB |
| LBDY | Study Day of Specimen Collection | Num | Timing | Study day of specimen collection, measured as integer days.Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. | Perm | LB | DY | 44 | SDTM Findings | LB | |
| LBENDY | Study Day of End of Observation | Num | Timing | Actual study day of end of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm | LB | ENDY | 45 | SDTM Findings | LB | |
| LBTPT | Planned Time Point Name | Char | Timing | Text description of time when specimen should be taken.This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See LBTPTNUM and LBTPTREF. Examples: "Start", "5 min post". | Perm | LB | TPT | 46 | SDTM Findings | LB | |
| LBTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of LBTPT to aid in sorting. | Perm | LB | TPTNUM | 47 | SDTM Findings | LB | |
| LBELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601) relative to a planned fixed reference (LBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable. Represented as ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by LBTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by LBTPTREF. | Perm | LB | ELTM | 48 | SDTM Findings | LB |
| LBTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by LBELTM, LBTPTNUM, and LBTPT. | Perm | LB | TPTREF | 49 | SDTM Findings | LB | |
| LBRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point, LBTPTREF. | Perm | LB | RFTDTC | 50 | SDTM Findings | LB |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | PC | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | PC | Identifier | Two-character abbreviation for the domain. | Req | PC | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Unique subject identifier within the submission. | Req | PC | USUBJID | 3 | SDTM Findings | ||
| PCSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | PC | SEQ | 4 | SDTM Findings | PC | |
| PCGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. | Perm | PC | GRPID | 5 | SDTM Findings | PC | |
| PCREFID | Reference ID | Char | Identifier | Internal or external specimen identifier. | Perm | PC | REFID | 6 | SDTM Findings | PC | |
| PCSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. | Perm | PC | SPID | 7 | SDTM Findings | PC | |
| PCTESTCD | Pharmacokinetic Test Short Name | Char | Topic | Short name of the analyte or specimen characteristic. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PCTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "ASA", "VOL", "SPG". | Req | PC | TESTCD | 8 | SDTM Findings | PC | |
| PCTEST | Pharmacokinetic Test Name | Char | Synonym Qualifier | Name of the analyte or specimen characteristic. Note any test normally performed by a clinical laboratory is considered a lab test. The value in PCTEST cannot be longer than 40 characters. Examples: "Acetylsalicylic Acid", "Volume", "Specific Gravity". | Req | PC | TEST | 9 | SDTM Findings | PC | |
| PCCAT | Test Category | Char | Grouping Qualifier | Used to define a category of related records. Examples: "ANALYTE", "SPECIMEN PROPERTY". | Perm | PC | CAT | 10 | SDTM Findings | PC | |
| PCSCAT | Test Subcategory | Char | Grouping Qualifier | A further categorization of a test category. | Perm | PC | SCAT | 11 | SDTM Findings | PC | |
| PCORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | PC | ORRES | 12 | SDTM Findings | PC | |
| PCORRESU | Original Units | Char | (PKUNIT) | Variable Qualifier | Original units in which the data were collected. The unit for PCORRES. Example: "mg/L". | Exp | PC | ORRESU | 13 | SDTM Findings | PC |
| PCSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PCORRES in a standard format or standard units. PCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in PCORRES, and these results effectively have the same meaning, they could be represented in standard format in PCSTRESC as "NEGATIVE". For other examples, see general assumptions. | Exp | PC | STRESC | 14 | SDTM Findings | PC | |
| PCSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from PCSTRESC. PCSTRESN should store all numeric test results or findings. | Exp | PC | STRESN | 15 | SDTM Findings | PC | |
| PCSTRESU | Standard Units | Char | (PKUNIT) | Variable Qualifier | Standardized unit used for PCSTRESC and PCSTRESN. | Exp | PC | STRESU | 16 | SDTM Findings | PC |
| PCSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate a result was not obtained. Should be null if a result exists in PCORRES. | Perm | PC | STAT | 17 | SDTM Findings | PC |
| PCREASND | Reason Test Not Done | Char | Record Qualifier | Describes why a result was not obtained, such as "SPECIMEN LOST". Used in conjunction with PCSTAT when value is "NOT DONE". | Perm | PC | REASND | 18 | SDTM Findings | PC | |
| PCNAM | Vendor Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor who provides the test results. | Exp | PC | NAM | 19 | SDTM Findings | PC | |
| PCSPEC | Specimen Material Type | Char | (SPECTYPE) | Record Qualifier | Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE". | Exp | PC | SPEC | 20 | SDTM Findings | PC |
| PCSPCCND | Specimen Condition | Char | (SPECCOND) | Record Qualifier | Free or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC". | Perm | PC | SPCCND | 21 | SDTM Findings | PC |
| PCMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method of the test or examination. Examples: "HPLC/MS", "ELISA". This should contain sufficient information and granularity to allow differentiation of various methods that might have been used within a study. | Perm | PC | METHOD | 22 | SDTM Findings | PC |
| PCFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. | Perm | PC | FAST | 23 | SDTM Findings | PC |
| PCLLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU. | Exp | PC | LLOQ | 24 | SDTM Findings | PC | |
| PCULOQ | Upper Limit of Quantitation | Num | Variable Qualifier | Indicates the upper limit of quantitation for an assay. Units should be those used in PCSTRESU. | Perm | PC | ULOQ | 25 | SDTM Findings | PC | |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | PC | VISITNUM | 26 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | PC | VISIT | 27 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | PC | VISITDY | 28 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | PC | TAETORD | 29 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. | Perm | PC | EPOCH | 30 | SDTM Findings | |
| PCDTC | Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/time of specimen collection represented in ISO 8601-character format. If there is no end time, then this will be the collection time. | Exp | PC | DTC | 31 | SDTM Findings | PC |
| PCENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | End date/time of specimen collection represented in ISO 8601-character format. If there is no end time, the collection time should be stored in PCDTC, and PCENDTC should be null. | Perm | PC | ENDTC | 32 | SDTM Findings | PC |
| PCDY | Actual Study Day of Specimen Collection | Num | Timing | Study day of specimen collection, measured as integer days.Algorithm for calculations must be relative to the applicant defined RFSTDTC variable in Demographics. | Perm | PC | DY | 33 | SDTM Findings | PC | |
| PCENDY | Study Day of End of Observation | Num | Timing | Actual study day of end of observation expressed in integer days relative to the applicant defined RFSTDTC in Demographics. | Perm | PC | ENDY | 34 | SDTM Findings | PC | |
| PCTPT | Planned Time Point Name | Char | Timing | Text description of time when specimen should be taken.This may be represented as an elapsed time relative to a fixed reference point, such as time of last exposure. See PCTPTNUM and PCTPTREF. Examples: "Start", "5 min post". | Perm | PC | TPT | 35 | SDTM Findings | PC | |
| PCTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of PCTPT to aid in sorting. | Perm | PC | TPTNUM | 36 | SDTM Findings | PC | |
| PCELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601) relative to a planned fixed reference (PCTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. | Perm | PC | ELTM | 37 | SDTM Findings | PC |
| PCTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point used as a basis for PCTPT, PCTPTNUM, and PCELTM. Example: "Most Recent Dose". | Perm | PC | TPTREF | 38 | SDTM Findings | PC | |
| PCRFTDTC | Date/Time of Reference Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point described by PCTPTREF. | Perm | PC | RFTDTC | 39 | SDTM Findings | PC |
| PCEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Evaluation Interval associated with a PCTEST record represented in ISO 8601-character format. Example: "-PT2H" to represent an interval of 2 hours prior to a PCTPT. | Perm | PC | EVLINT | 40 | SDTM Findings | PC |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | PP | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | PP | Identifier | Two-character abbreviation for the domain. | Req | PP | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Unique subject identifier within the submission. | Req | PP | USUBJID | 3 | SDTM Findings | ||
| PPSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | PP | SEQ | 4 | SDTM Findings | PP | |
| PPGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. | Perm | PP | GRPID | 5 | SDTM Findings | PP | |
| PPTESTCD | Parameter Short Name | Char | (PKPARMCD) | Topic | Short name of the pharmacokinetic parameter. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "AUCALL", "TMAX", "CMAX". | Req | PP | TESTCD | 6 | SDTM Findings | PP |
| PPTEST | Parameter Name | Char | (PKPARM) | Synonym Qualifier | Name of the pharmacokinetic parameter. The value in PPTEST cannot be longer than 40 characters. Examples: "AUC All", "Time of CMAX", "Max Conc". | Req | PP | TEST | 7 | SDTM Findings | PP |
| PPCAT | Parameter Category | Char | Grouping Qualifier | Used to define a category of related records. For PP, this should be the name of the analyte in PCTEST whose profile the parameter is associated with. | Exp | PP | CAT | 8 | SDTM Findings | PP | |
| PPSCAT | Parameter Subcategory | Char | Grouping Qualifier | Categorization of the model type used to calculate the PK parameters. Examples: "COMPARTMENTAL", "NON-COMPARTMENTAL". | Perm | PP | SCAT | 9 | SDTM Findings | PP | |
| PPORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | PP | ORRES | 10 | SDTM Findings | PP | |
| PPORRESU | Original Units | Char | (PKUNIT) \n (PKUWG) \n (PKUWKG) \n (PKUDMG) \n (PKUDUG) | Variable Qualifier | Original units in which the data were collected. The unit for PPORRES. | Exp | PP | ORRESU | 11 | SDTM Findings | PP |
| PPSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PPORRES in a standard format or standard units. PPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PPSTRESN. | Exp | PP | STRESC | 12 | SDTM Findings | PP | |
| PPSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from PPSTRESC. PPSTRESN should store all numeric test results or findings. | Exp | PP | STRESN | 13 | SDTM Findings | PP | |
| PPSTRESU | Standard Units | Char | (PKUNIT) \n (PKUWG) \n (PKUWKG) \n (PKUDMG) \n (PKUDUG) | Variable Qualifier | Standardized unit used for PPSTRESC and PPSTRESN. | Exp | PP | STRESU | 14 | SDTM Findings | PP |
| PPSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES. | Perm | PP | STAT | 15 | SDTM Findings | PP |
| PPREASND | Reason Parameter Not Calculated | Char | Record Qualifier | Describes why a parameter was not calculated, such as "INSUFFICIENT DATA". Used in conjunction with PPSTAT when value is "NOT DONE". | Perm | PP | REASND | 16 | SDTM Findings | PP | |
| PPSPEC | Specimen Material Type | Char | (SPECTYPE) | Record Qualifier | Defines the type of specimen used for a measurement. If multiple specimen types are used for a calculation (e.g., serum and urine for renal clearance), then this field should be left blank. Examples: "SERUM", "PLASMA", "URINE". | Exp | PP | SPEC | 17 | SDTM Findings | PP |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | PP | TAETORD | 18 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. | Perm | PP | EPOCH | 19 | SDTM Findings | |
| PPDTC | Date/Time of Parameter Calculations | Char | ISO 8601 datetime or interval | Timing | Nominal date/time of parameter calculations. | Perm | PP | DTC | 20 | SDTM Findings | PP |
| PPDY | Study Day of Parameter Calculations | Num | Timing | Study day of the collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | PP | DY | 21 | SDTM Findings | PP | |
| PPRFTDTC | Date/Time of Reference Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point from the PC records used to calculate a parameter record. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. | Exp | PP | RFTDTC | 22 | SDTM Findings | PP |
| PPSTINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing | The start of a planned evaluation or assessment interval relative to the Time Point Reference. | Perm | PP | STINT | 23 | SDTM Findings | PP |
| PPENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing | The end of a planned evaluation or assessment interval relative to the Time Point Reference. | Perm | PP | ENINT | 24 | SDTM Findings | PP |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | PT | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | PT | Identifier | Two-character abbreviation for the domain. | Req | PT | DOMAIN | 2 | SDTM Findings | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | Req | PT | SPTOBID | 3 | SDTM Findings | ||
| IGDCMPID | Ingredient or Component Identifier | Char | Identifier | Identifier given to an ingredient, substance or component of a tobacco product (e.g., "Burley Tobacco", "Reconstituted Tobacco"). It originates in the IT or IN domain. See PT assumption 7a below for more information. | Perm | PT | IGDCMPID | 4 | SDTM Findings | ||
| STOCONID | Applicant-defined Storage Conditions ID | Char | Identifier | Applicant-defined identifier for a set of storage conditions that are represented in the ES domain, where this identifier originates. See assumption 7b below for more information. (See also ES domain Specification and Assumptions for more information on the ES domain). | Perm | PT | STOCONID | 5 | SDTM Findings | ||
| PTSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | PT | SEQ | 6 | SDTM Findings | PT | |
| PTGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | PT | GRPID | 7 | SDTM Findings | PT | |
| PTREFID | Reference ID | Char | Identifier | Internal or external identifier. In PT it is used to represent a smoking regimen, and serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine. | Perm | PT | REFID | 8 | SDTM Findings | PT | |
| PTSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Can be used to identify an instance of an observation. Examples: a value pre-printed on a form; an identifier from the applicant's operational database. | Perm | PT | SPID | 9 | SDTM Findings | PT | |
| PTTESTCD | Test or Examination Short Name. | Char | (PTTESTCD) | Topic | Short name of the measurement or test described in PTTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PTTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PTTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "NH4", "BENZ". | Req | PT | TESTCD | 10 | SDTM Findings | PT |
| PTTEST | Test or Examination Name | Char | (PTTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in PTTEST cannot be longer than 40 characters. Examples: "Ammonia", "Benzene". | Req | PT | TEST | 11 | SDTM Findings | PT |
| PTTSTDTL | Test Detail | Char | Record Qualifier | Further description of the test performed in producing the PT result (e.g., "DRY WEIGHT BASIS" in HPHC testing or stability testing). | Perm | PT | TSTDTL | 12 | SDTM Findings | PT | |
| PTCAT | Category of Test | Char | (PTCAT) | Grouping Qualifier | Used to define a category of related records by purpose. Examples: "HPHC TESTING", "STABILITY TESTING", "DESIGN PARAMETER TESTING". Note: given the vast amount of data types that will use this domain, PTCAT is a required variable in the PT domain to differentiate and group the records by purpose. | Req | PT | CAT | 13 | SDTM Findings | PT |
| PTSCAT | Subcategory of Test | Char | Grouping Qualifier | A further categorization of a test category. Examples: "HPHC" (for constituents designated as HPHCs under PTCAT=HPHC TESTING), "OTHER" (for constituents like tar, which are categorized under PTCAT=HPHC TESTING but that are not formally designated HPHCs). | Perm | PT | SCAT | 14 | SDTM Findings | PT | |
| PTORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | PT | ORRES | 15 | SDTM Findings | PT | |
| PTORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for PTORRES. Example: "mg/mL". | Exp | PT | ORRESU | 16 | SDTM Findings | PT |
| PTLLOD | Lower Limit of Detection | Char | Variable Qualifier | The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. The value for the field will be as described in documentation from the instrument or lab vendor. | Perm | PT | LLOD | 17 | SDTM Findings | PT | |
| PTSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PTORRES in a standard format or standard units. PTSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PTSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in PTORRES and these results effectively have the same meaning, they could be represented in standard format in PTSTRESC as "NEGATIVE". For other examples, see general assumptions. | Exp | PT | STRESC | 18 | SDTM Findings | PT | |
| PTSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from PTSTRESC. PTSTRESN should store all numeric test results or findings. | Exp | PT | STRESN | 19 | SDTM Findings | PT | |
| PTSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for PTSTRESC or PTSTRESN. | Exp | PT | STRESU | 20 | SDTM Findings | PT |
| PTSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate exam not done. Should be null if a result exists in PTORRES. | Perm | PT | STAT | 21 | SDTM Findings | PT |
| PTREASND | Reason Test Not Done | Char | Record Qualifier | Describes why a measurement or test was not performed, e.g., "BROKEN EQUIPMENT", or "SAMPLE LOST". Used in conjunction with PTSTAT when value is "NOT DONE". | Perm | PT | REASND | 22 | SDTM Findings | PT | |
| PTXFN | External File Path | Char | Record Qualifier | The filename and/or path to external data not stored in the same format and possibly not the same location as the other data for a study. For example, when submitting lab methodology as a separate document, the name of the document or path to the file in the folder structure in the submission should be referred to in this variable. | Perm | PT | XFN | 23 | SDTM Findings | PT | |
| PTNAM | Vendor Name | Char | Record Qualifier | The name or identifier of the laboratory that performed the test. | Perm | PT | NAM | 24 | SDTM Findings | PT | |
| PTSPEC | Specimen Material Type | Char | (SPECPT) | Record Qualifier | Defines the type of sample/matrix used for a measurement. Examples: "TOBACCO", "E-LIQUID", "SMOKE", "AEROSOL". | Exp | PT | SPEC | 25 | SDTM Findings | PT |
| PTSPCCND | Specimen Condition | Char | (SPECCOND) | Record Qualifier | The physical state or quality of a sample for an assessment. Examples: "AS-IS", "DRY WEIGHT BASIS". | Perm | PT | SPCCND | 26 | SDTM Findings | PT |
| PTMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method used to arrive at the result of the test or examination. Not for representing smoking regimens or sample storage conditions. If lab methodology is too complex for this single variable, and supplemental lab documentation is instead submitted, a file name or path to such documentation should be included in the PTXFN variable instead. | Perm | PT | METHOD | 27 | SDTM Findings | PT |
| PTBLFL | Baseline Flag | Char | (NY) | Record Qualifier | Indicator used to identify a baseline value. Should be "Y" or null. Note that PTBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset. | Perm | PT | BLFL | 28 | SDTM Findings | PT |
| PTDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records, or do not come from the CRF, or are not as originally received or collected are examples of records that might be derived for the submission datasets. If PTDRVFL = "Y", then PTORRES may be null, with PTSTRESC and (if numeric) PTSTRESN having the derived value. | Perm | PT | DRVFL | 29 | SDTM Findings | PT |
| PTLLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units. | Perm | PT | LLOQ | 30 | SDTM Findings | PT | |
| PTULOQ | Upper Limit of Quantitation | Num | Variable Qualifier | The highest threshold for reliably detecting the result of a specific test in standardized units. | Perm | PT | ULOQ | 31 | SDTM Findings | PT | |
| PTREPNUM | Repetition Number | Num | Record Qualifier | The instance number of a test that is repeated within a given time frame for the same test performed. The level of granularity can vary (e.g., within a time point). Example: multiple measurements of tobacco product testing for a specific test. | Perm | PT | REPNUM | 32 | SDTM Findings | PT | |
| PTDTC | Date/Time of Sample Testing | Char | ISO 8601 datetime or interval | Timing | Date/time of sample testing represented in ISO 8601 character format. | Exp | PT | DTC | 33 | SDTM Findings | PT |
| PTENDTC | End Date/Time of Sample Collection | Char | ISO 8601 datetime or interval | Timing | End date/time of sample collection represented in ISO 8601 character format. Used when I sample is collected over a period of time, and the length of time is deemed significant to the test or the interpretation if its result. | Perm | PT | ENDTC | 34 | SDTM Findings | PT |
| PTTPT | Planned Time Point Name | Char | Timing | 1. Text description of time when sample should be tested. \n 2. This may be represented as an elapsed time relative to a fixed reference point, such as date of manufacture. See PTTPTNUM and PTTPTREF. Examples: "Week 12". | Perm | PT | TPT | 35 | SDTM Findings | PT | |
| PTTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of PTTPT to aid in sorting. | Perm | PT | TPTNUM | 36 | SDTM Findings | PT | |
| PTELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601) relative to a planned fixed reference (PTTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable. Represented as ISO 8601 duration. Example: "PT60D" to represent the period of 60 days after the reference point indicated by PTTPTREF. | Perm | PT | ELTM | 37 | SDTM Findings | PT |
| PTTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by PTELTM, PTTPTNUM, and PTTPT. Example: "DATE OF MANUFACTURE". | Perm | PT | TPTREF | 38 | SDTM Findings | PT | |
| PTRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point, PTTPTREF. | Perm | PT | RFTDTC | 39 | SDTM Findings | PT |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | QS | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | QS | Identifier | Two-character abbreviation for the domain. | Req | QS | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | QS | USUBJID | 3 | SDTM Findings | ||
| QSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | QS | SEQ | 4 | SDTM Findings | QS | |
| QSGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | QS | GRPID | 5 | SDTM Findings | QS | |
| QSSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Question number on a questionnaire. | Perm | QS | SPID | 6 | SDTM Findings | QS | |
| QSTESTCD | Question Short Name | Char | Topic | Topic variable for QS. Short name for the value in QSTEST, which can be used as a column name when converting the dataset from a vertical format to a horizontal format. The value in QSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). QSTESTCD cannot contain characters other than letters, numbers, or underscores. \n Controlled terminology for QSTESTCD is published in separate codelists for each questionnaire. Examples: "ADCCMD01", "BPR0103". | Req | QS | TESTCD | 7 | SDTM Findings | QS | |
| QSTEST | Question Name | Char | Synonym Qualifier | Verbatim name of the question or group of questions used to obtain the measurement or finding. The value in QSTEST cannot be longer than 40 characters. \n Controlled terminology for QSTEST is published in separate codelists for each questionnaire. Example: "BPR01 - Emotional Withdrawal". | Req | QS | TEST | 8 | SDTM Findings | QS | |
| QSCAT | Category of Question | Char | (QSCAT) | Grouping Qualifier | Used to specify the questionnaire in which the question identified by QSTEST and QSTESTCD was included. Examples: "ADAS-COG", "MDS-UPDRS". | Req | QS | CAT | 9 | SDTM Findings | QS |
| QSSCAT | Subcategory for Question | Char | Grouping Qualifier | A further categorization of the questions within the category. Examples: "MENTAL HEALTH" , "DEPRESSION", "WORD RECALL". | Perm | QS | SCAT | 10 | SDTM Findings | QS | |
| QSORRES | Finding in Original Units | Char | Result Qualifier | Finding as originally received or collected (e.g., "RARELY", "SOMETIMES"). When applicants apply codelist to indicate that code values are statistically meaningful standardized scores (which are defined by applicants or by valid methodologies, e.g., SF36 questionnaires), QSORRES will contain the decode format; QSSTRESC and QSSTRESN may contain the standardized code values or scores. | Exp | QS | ORRES | 11 | SDTM Findings | QS | |
| QSORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for QSORRES, such as minutes or seconds or the units associated with a visual analog scale. | Perm | QS | ORRESU | 12 | SDTM Findings | QS |
| QSSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the finding for all questions or subscores copied or derived from QSORRES, in a standard format or standard units. QSSTRESC should store all findings in character format; if findings are numeric, they should also be stored in numeric format in QSSTRESN. If question scores are derived from the original finding, then the standard format is the score. Examples: "0", "1". \n When applicants apply codelist to indicate the code values are statistically meaningful standardized scores (which are defined by applicants or by valid methodologies, e.g., SF36 questionnaires), QSORRES will contain the decode format; QSSTRESC and QSSTRESN may contain the standardized code values or scores. | Exp | QS | STRESC | 13 | SDTM Findings | QS | |
| QSSTRESN | Numeric Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric findings in standard format; copied in numeric format from QSSTRESC. QSSTRESN should store all numeric results or findings. | Perm | QS | STRESN | 14 | SDTM Findings | QS | |
| QSSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for QSSTRESC or QSSTRESN. | Perm | QS | STRESU | 15 | SDTM Findings | QS |
| QSSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a question was not done or was not answered. Should be null if a result exists in QSORRES. | Perm | QS | STAT | 16 | SDTM Findings | QS |
| QSREASND | Reason Not Performed | Char | Record Qualifier | Describes why a question was not answered. Used in conjunction with QSSTAT when value is "NOT DONE". Example: "SUBJECT REFUSED". | Perm | QS | REASND | 17 | SDTM Findings | QS | |
| QSMETHOD | Method of Test or Examination | Char | (QRSMTHOD) | Record Qualifier | Method of the test or examination. | Perm | QS | METHOD | 18 | SDTM Findings | QS |
| QSLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. | Exp | QS | LOBXFL | 19 | SDTM Findings | QS |
| QSBLFL | Baseline Flag | Char | (NY) | Record Qualifier | Indicator used to identify a baseline value. Should be "Y" or null. Note that QSBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset. | Perm | QS | BLFL | 20 | SDTM Findings | QS |
| QSDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records or questionnaire subscores that do not come from the CRF are examples of records that would be derived for the submission datasets. If QSDRVFL = "Y", then QSORRES may be null with QSSTRESC and (if numeric) QSSTRESN having the derived value. | Perm | QS | DRVFL | 21 | SDTM Findings | QS |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | QS | VISITNUM | 22 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | QS | VISIT | 23 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | QS | VISITDY | 24 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm for the element in which the assessment was made. | Perm | QS | TAETORD | 25 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the observation date/time of the physical exam finding. | Perm | QS | EPOCH | 26 | SDTM Findings | |
| QSDTC | Date/Time of Finding | Char | ISO 8601 datetime or interval | Timing | Date of questionnaire. | Exp | QS | DTC | 27 | SDTM Findings | QS |
| QSDY | Study Day of Finding | Num | Timing | Study day of finding collection, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | QS | DY | 28 | SDTM Findings | QS | |
| QSTPT | Planned Time Point Name | Char | Timing | Text description of time when questionnaire should be administered. This may be represented as an elapsed time relative to a fixed reference point (e.g., "TIME OF LAST DOSE"). See QSTPTNUM and QSTPTREF. | Perm | QS | TPT | 29 | SDTM Findings | QS | |
| QSTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of QSTPT to aid in sorting. | Perm | QS | TPTNUM | 30 | SDTM Findings | QS | |
| QSELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601) relative to a planned fixed reference (QSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by QSTPTREF, "PT8H" to represent the period of 8 hours after the reference point indicated by QSTPTREF. | Perm | QS | ELTM | 31 | SDTM Findings | QS |
| QSTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by QSELTM, QSTPTNUM, and QSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". | Perm | QS | TPTREF | 32 | SDTM Findings | QS | |
| QSRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point, QSTPTREF. | Perm | QS | RFTDTC | 33 | SDTM Findings | QS |
| QSEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Evaluation interval associated with a QSTEST question represented in ISO 8601 character format. Example: "-P2Y" to represent an interval of 2 years in the question "Have you experienced any episodes in the past 2 years?". | Perm | QS | EVLINT | 34 | SDTM Findings | QS |
| QSEVINTX | Evaluation Interval Text | Char | Timing | Evaluation interval associated with an observation, where the interval is not able to be represented in ISO 8601 format. Examples: "LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS". | Perm | QS | EVINTX | 35 | SDTM Findings | QS | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | RE | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | RE | Identifier | Two-character abbreviation for the domain. | Req | RE | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | RE | USUBJID | 3 | SDTM Findings | ||
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for a device. | Perm | RE | SPDEVID | 4 | SDTM Findings | ||
| RESEQ | Sequence Number | Num | Identifier | 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. | Req | RE | SEQ | 5 | SDTM Findings | RE | |
| REGRPID | Group ID | Char | Identifier | Optional group identifier, used to link together a block of related records within a subject in a domain. | Perm | RE | GRPID | 6 | SDTM Findings | RE | |
| REREFID | Reference ID | Char | Identifier | Optional internal or external procedure identifier. | Perm | RE | REFID | 7 | SDTM Findings | RE | |
| RESPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined identifier. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. | Perm | RE | SPID | 8 | SDTM Findings | RE | |
| RELNKID | Link ID | Char | Identifier | Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. | Perm | RE | LNKID | 9 | SDTM Findings | RE | |
| RELNKGRP | Link Group | Char | Identifier | Identifier used to link related records across domains. This will usually be a many-to-one relationship. | Perm | RE | LNKGRP | 10 | SDTM Findings | RE | |
| RETESTCD | Short Name of Respiratory Test | Char | (RETESTCD) | Topic | Short name of the measurement, test, or examination. It can be used as a column name when converting a dataset from a vertical format to a horizontal format. The value in RETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). RETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "FEV1", "FVC". | Req | RE | TESTCD | 11 | SDTM Findings | RE |
| RETEST | Name of Respiratory Test | Char | (RETEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in RETEST cannot be longer than 40 characters. Examples: "Forced Expiratory Volume in 1 Second", "Forced Vital Capacity". | Req | RE | TEST | 12 | SDTM Findings | RE |
| RECAT | Category for Respiratory Test | Char | Grouping Qualifier | Used to categorize observations across subjects. | Perm | RE | CAT | 13 | SDTM Findings | RE | |
| RESCAT | Subcategory for Respiratory Test | Char | Grouping Qualifier | A further categorization. | Perm | RE | SCAT | 14 | SDTM Findings | RE | |
| REPOS | Position of Subject During Observation | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". | Perm | RE | POS | 15 | SDTM Findings | RE |
| REORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the procedure measurement or finding as originally received or collected. | Exp | RE | ORRES | 16 | SDTM Findings | RE | |
| REORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for REORRES and REORREF. | Perm | RE | ORRESU | 17 | SDTM Findings | RE |
| REORREF | Reference Result in Original Units | Char | Variable Qualifier | Reference result for continuous measurements in original units. Should be collected only for continuous results. | Perm | RE | ORREF | 18 | SDTM Findings | RE | |
| RESTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from REORRES in a standard format or in standard units. RESTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RESTRESN. | Exp | RE | STRESC | 19 | SDTM Findings | RE | |
| RESTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from RESTRESC. RESTRESN should store all numeric test results or findings. | Perm | RE | STRESN | 20 | SDTM Findings | RE | |
| RESTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for RESTRESC, RESTRESN and RESTREFN. | Perm | RE | STRESU | 21 | SDTM Findings | RE |
| RESTREFC | Character Reference Result | Char | Variable Qualifier | Reference value for the result or finding copied or derived from --ORREF in a standard format. | Perm | RE | STREFC | 22 | SDTM Findings | RE | |
| RESTREFN | Numeric Reference Result in Std Units | Num | Variable Qualifier | Reference result for continuous measurements in standard units. Should be populated only for continuous results. | Perm | RE | STREFN | 23 | SDTM Findings | RE | |
| RESTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a test was not done or a measurement was not taken. Should be null if a result exists in REORRES. | Perm | RE | STAT | 24 | SDTM Findings | RE |
| REREASND | Reason Not Done | Char | Record Qualifier | Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with RESTAT when value is "NOT DONE". | Perm | RE | REASND | 25 | SDTM Findings | RE | |
| RELOC | Location Used for the Measurement | Char | (LOC) | Record Qualifier | Anatomical location of the subject relevant to the collection of the measurement. Examples: "LUNG", "BRONCHUS". | Perm | RE | LOC | 26 | SDTM Findings | RE |
| RELAT | Laterality | Char | (LAT) | Variable Qualifier | Side of the body used to collect measurement. Examples: "RIGHT", "LEFT". | Perm | RE | LAT | 27 | SDTM Findings | RE |
| REDIR | Directionality | Char | (DIR) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL". | Perm | RE | DIR | 28 | SDTM Findings | RE |
| REMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method used to create the result. | Perm | RE | METHOD | 29 | SDTM Findings | RE |
| RELOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. | Exp | RE | LOBXFL | 30 | SDTM Findings | RE |
| REEVAL | Evaluator | Char | (EVAL) | Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST". | Perm | RE | EVAL | 31 | SDTM Findings | RE |
| REEVALID | Evaluator Identifier | Char | (MEDEVAL) | Variable Qualifier | Used to distinguish multiple evaluators with the same role recorded in REEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2". | Perm | RE | EVALID | 32 | SDTM Findings | RE |
| REREPNUM | Repetition Number | Num | Record Qualifier | The instance number of a test that is repeated within a given time frame for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of pulmonary function. | Perm | RE | REPNUM | 33 | SDTM Findings | RE | |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | RE | VISITNUM | 34 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | RE | VISIT | 35 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | RE | VISITDY | 36 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. | Perm | RE | TAETORD | 37 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the date/time at which the assessment was made. | Perm | RE | EPOCH | 38 | SDTM Findings | |
| REDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date/time of procedure or test. | Exp | RE | DTC | 39 | SDTM Findings | RE |
| REDY | Study Day of Visit/Collection/Exam | Num | Timing | Actual study day of visit/collection/exam expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm | RE | DY | 40 | SDTM Findings | RE | |
| RETPT | Planned Time Point Name | Char | Timing | 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 RETPTNUM and RETPTREF. Examples: "Start", "5 minutes post". | Perm | RE | TPT | 41 | SDTM Findings | RE | |
| RETPTNUM | Planned Time Point Number | Num | Timing | Numeric version of RETPT to aid in sorting. | Perm | RE | TPTNUM | 42 | SDTM Findings | RE | |
| REELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned Elapsed time relative to a planned fixed reference (RETPTREF). Not a clock time or a date/time variable, but an interval, represented as ISO duration. Examples: "-PT15M" to represent 15 minutes prior to the reference time point indicated by RETPTREF, or "PT8H" to represent 8 hours after the reference time point represented by RETPTREF. | Perm | RE | ELTM | 43 | SDTM Findings | RE |
| RETPTREF | Time Point Reference | Char | Timing | Description of the fixed reference point referred to by REELTM, RETPTNUM, and RETPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". | Perm | RE | TPTREF | 44 | SDTM Findings | RE | |
| RERFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time for a fixed reference time point defined by RETPTREF. | Perm | RE | RFTDTC | 45 | SDTM Findings | RE |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | SC | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | SC | Identifier | Two-character abbreviation for the domain. | Req | SC | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | SC | USUBJID | 3 | SDTM Findings | ||
| SCSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | SC | SEQ | 4 | SDTM Findings | SC | |
| SCGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | SC | GRPID | 5 | SDTM Findings | SC | |
| SCSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. | Perm | SC | SPID | 6 | SDTM Findings | SC | |
| SCTESTCD | Subject Characteristic Short Name | Char | (SCTESTCD) | Topic | Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "MARISTAT", "NATORIG". | Req | SC | TESTCD | 7 | SDTM Findings | SC |
| SCTEST | Subject Characteristic | Char | (SCTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in SCTEST cannot be longer than 40 characters. Examples: "Marital Status", "National Origin". | Req | SC | TEST | 8 | SDTM Findings | SC |
| SCCAT | Category for Subject Characteristic | Char | Grouping Qualifier | Used to define a category of related records. | Perm | SC | CAT | 9 | SDTM Findings | SC | |
| SCSCAT | Subcategory for Subject Characteristic | Char | Grouping Qualifier | A further categorization of the subject characteristic. | Perm | SC | SCAT | 10 | SDTM Findings | SC | |
| SCORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the subject characteristic as originally received or collected. | Exp | SC | ORRES | 11 | SDTM Findings | SC | |
| SCORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original unit in which the data were collected. The unit for SCORRES. | Perm | SC | ORRESU | 12 | SDTM Findings | SC |
| SCSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings copied or derived from SCORRES, in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in SCORRES, and these results effectively have the same meaning, they could be represented in standard format in SCSTRESC as "NEGATIVE". | Exp | SC | STRESC | 13 | SDTM Findings | SC | |
| SCSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from SCSTRESC. SCSTRESN should store all numeric test results or findings. | Perm | SC | STRESN | 14 | SDTM Findings | SC | |
| SCSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for SCSTRESC or SCSTRESN. | Perm | SC | STRESU | 15 | SDTM Findings | SC |
| SCSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that the measurement was not done. Should be null if a result exists in SCORRES. | Perm | SC | STAT | 16 | SDTM Findings | SC |
| SCREASND | Reason Not Performed | Char | Record Qualifier | Describes why the observation has no result. Example: "Subject refused". Used in conjunction with SCSTAT when value is "NOT DONE". | Perm | SC | REASND | 17 | SDTM Findings | SC | |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Perm | SC | VISITNUM | 18 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | SC | VISIT | 19 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | SC | VISITDY | 20 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm. | Perm | SC | TAETORD | 21 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time at which the assessment was made. | Perm | SC | EPOCH | 22 | SDTM Findings | |
| SCDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of the subject characteristic represented in ISO 8601 character format. | Perm | SC | DTC | 23 | SDTM Findings | SC |
| SCDY | Study Day of Examination | Num | Timing | Study day of collection, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | SC | DY | 24 | SDTM Findings | SC | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | VS | STUDYID | 1 | SDTM Findings | ||
| DOMAIN | Domain Abbreviation | Char | VS | Identifier | Two-character abbreviation for the domain. | Req | VS | DOMAIN | 2 | SDTM Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | VS | USUBJID | 3 | SDTM Findings | ||
| VSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | VS | SEQ | 4 | SDTM Findings | VS | |
| VSGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | VS | GRPID | 5 | SDTM Findings | VS | |
| VSSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. | Perm | VS | SPID | 6 | SDTM Findings | VS | |
| VSTESTCD | Vital Signs Test Short Name | Char | (VSTESTCD) | Topic | Short name of the measurement, test, or examination described in VSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in VSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). VSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SYSBP", "DIABP", "BMI". | Req | VS | TESTCD | 7 | SDTM Findings | VS |
| VSTEST | Vital Signs Test Name | Char | (VSTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in VSTEST cannot be longer than 40 characters. Examples: "Systolic Blood Pressure", "Diastolic Blood Pressure", "Body Mass Index". | Req | VS | TEST | 8 | SDTM Findings | VS |
| VSCAT | Category for Vital Signs | Char | Grouping Qualifier | Used to define a category of related records. | Perm | VS | CAT | 9 | SDTM Findings | VS | |
| VSSCAT | Subcategory for Vital Signs | Char | Grouping Qualifier | A further categorization of a measurement or examination. | Perm | VS | SCAT | 10 | SDTM Findings | VS | |
| VSPOS | Vital Signs Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". | Perm | VS | POS | 11 | SDTM Findings | VS |
| VSORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the vital signs measurement as originally received or collected. | Exp | VS | ORRES | 12 | SDTM Findings | VS | |
| VSORRESU | Original Units | Char | (VSRESU) | Variable Qualifier | Original units in which the data were collected. The unit for VSORRES. Examples: "in", "LB", "beats/min". | Exp | VS | ORRESU | 13 | SDTM Findings | VS |
| VSSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from VSORRES in a standard format or standard units. VSSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in VSSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in VSORRES, and these results effectively have the same meaning, they could be represented in standard format in VSSTRESC as "NEGATIVE". | Exp | VS | STRESC | 14 | SDTM Findings | VS | |
| VSSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; copied in numeric format from VSSTRESC. VSSTRESN should store all numeric test results or findings. | Exp | VS | STRESN | 15 | SDTM Findings | VS | |
| VSSTRESU | Standard Units | Char | (VSRESU) | Variable Qualifier | Standardized unit used for VSSTRESC and VSSTRESN. | Exp | VS | STRESU | 16 | SDTM Findings | VS |
| VSSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a vital sign measurement was not done. Should be null if a result exists in VSORRES. | Perm | VS | STAT | 17 | SDTM Findings | VS |
| VSREASND | Reason Not Performed | Char | Record Qualifier | Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with VSSTAT when value is "NOT DONE". | Perm | VS | REASND | 18 | SDTM Findings | VS | |
| VSLOC | Location of Vital Signs Measurement | Char | (LOC) | Record Qualifier | Location relevant to the collection of vital signs measurement. Example: "ARM" for blood pressure. | Perm | VS | LOC | 19 | SDTM Findings | VS |
| VSLAT | Laterality | Char | (LAT) | Result Qualifier | Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". | Perm | VS | LAT | 20 | SDTM Findings | VS |
| VSLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. | Exp | VS | LOBXFL | 21 | SDTM Findings | VS |
| VSTOX | Toxicity | Char | Variable Qualifier | Description of toxicity quantified by VSTOXGR. | Perm | VS | TOX | 22 | SDTM Findings | VS | |
| VSTOXGR | Standard Toxicity Grade | Char | Record Qualifier | Records toxicity grade value using a standard toxicity scale (e.g., NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2", not "Grade 2"). | Perm | VS | TOXGR | 23 | SDTM Findings | VS | |
| VSCLSIG | Clinically Significant, Collected | Char | (NY) | Record Qualifier | Used to indicate whether a collected observation is clinically significant based on judgment. | Perm | VS | CLSIG | 24 | SDTM Findings | VS |
| VISITNUM | Visit Number | Num | Timing | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Exp | VS | VISITNUM | 25 | SDTM Findings | ||
| VISIT | Visit Name | Char | Timing | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | VS | VISIT | 26 | SDTM Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm | VS | VISITDY | 27 | SDTM Findings | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm. | Perm | VS | TAETORD | 28 | SDTM Findings | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time at which the assessment was made. | Perm | VS | EPOCH | 29 | SDTM Findings | |
| VSDTC | Date/Time of Measurements | Char | ISO 8601 datetime or interval | Timing | Date and time of the vital signs assessment represented in ISO 8601 character format. | Exp | VS | DTC | 30 | SDTM Findings | VS |
| VSDY | Study Day of Vital Signs | Num | Timing | Study day of vital signs measurements, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | VS | DY | 31 | SDTM Findings | VS | |
| VSTPT | Planned Time Point Name | Char | Timing | Text description of time when measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point (e.g., time of last dose). See VSTPTNUM and VSTPTREF. Examples: "START", "5 MIN POST". | Perm | VS | TPT | 32 | SDTM Findings | VS | |
| VSTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of VSTPT to aid in sorting. | Perm | VS | TPTNUM | 33 | SDTM Findings | VS | |
| VSELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601) relative to a planned fixed reference (VSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 Duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by VSTPTREF, "PT8H" to represent the period of 8 hours after the reference point indicated by VSTPTREF. | Perm | VS | ELTM | 34 | SDTM Findings | VS |
| VSTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by VSELTM, VSTPTNUM, and VSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". | Perm | VS | TPTREF | 35 | SDTM Findings | VS | |
| VSRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time of the reference time point, VSTPTREF. | Perm | VS | RFTDTC | 36 | SDTM Findings | VS |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | CM | STUDYID | 1 | SDTM Interventions | ||
| DOMAIN | Domain Abbreviation | Char | CM | Identifier | Two-character abbreviation for the domain. | Req | CM | DOMAIN | 2 | SDTM Interventions | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | CM | USUBJID | 3 | SDTM Interventions | ||
| CMSEQ | Sequence Number | Num | Identifier | Sequence number to ensure uniqueness of subject records within a domain. May be any valid number. | Req | CM | SEQ | 4 | SDTM Interventions | CM | |
| CMGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | CM | GRPID | 5 | SDTM Interventions | CM | |
| CMSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Example: a number preprinted on the CRF as an explicit line identifier or record identifier defined in the applicant's operational database. Example: line number on a concomitant medication page. | Perm | CM | SPID | 6 | SDTM Interventions | CM | |
| CMTRT | Reported Name of Drug, Med, or Therapy | Char | Topic | Verbatim medication name that is either preprinted or collected on a CRF. | Req | CM | TRT | 7 | SDTM Interventions | CM | |
| CMMODIFY | Modified Reported Name | Char | Synonym Qualifier | If CMTRT is modified to facilitate coding, then CMMODIFY will contain the modified text. | Perm | CM | MODIFY | 8 | SDTM Interventions | CM | |
| CMDECOD | Standardized Medication Name | Char | Synonym Qualifier | Standardized or dictionary-derived text description of CMTRT or CMMODIFY. Equivalent to the generic drug name in WHO Drug. If an intervention term does not have a decode value in the dictionary, then CMDECOD will be left blank. | Perm | CM | DECOD | 9 | SDTM Interventions | CM | |
| CMCAT | Category for Medication | Char | Grouping Qualifier | Used to define a category of interventions (e.g., medications/treatments/products). Examples: "PRIOR", "CONCOMITANT", "ANTI-CANCER MEDICATION", "GENERAL CONMED". | Perm | CM | CAT | 10 | SDTM Interventions | CM | |
| CMSCAT | Subcategory for Medication | Char | Grouping Qualifier | A further categorization of interventions (e.g., medications/treatments/products). Examples: "CHEMOTHERAPY", "HORMONAL THERAPY", "ALTERNATIVE THERAPY". | Perm | CM | SCAT | 11 | SDTM Interventions | CM | |
| CMPRESP | CM Pre-specified | Char | (NY) | Variable Qualifier | Used to indicate whether ("Y"/null) information about the use of a specific medication was solicited on the CRF. | Perm | CM | PRESP | 12 | SDTM Interventions | CM |
| CMOCCUR | CM Occurrence | Char | (NY) | Record Qualifier | When the use of a specific medication is solicited. CMOCCUR is used to indicate whether ("Y"/"N") use of the medication occurred. Values are null for medications not specifically solicited. | Perm | CM | OCCUR | 13 | SDTM Interventions | CM |
| CMSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE". | Perm | CM | STAT | 14 | SDTM Interventions | CM |
| CMREASND | Reason Medication Not Collected | Char | Record Qualifier | Reason not done. Used in conjunction with CMSTAT when value is "NOT DONE". | Perm | CM | REASND | 15 | SDTM Interventions | CM | |
| CMINDC | Indication | Char | Record Qualifier | Denotes why a medication was taken or administered. Examples: "NAUSEA", "HYPERTENSION". | Perm | CM | INDC | 16 | SDTM Interventions | CM | |
| CMCLAS | Medication Class | Char | Variable Qualifier | Drug class. May be obtained from coding. When coding to a single class, populate with class value. If using a dictionary and coding to multiple classes, then populate multiple values per TIG guidance or omit CMCLAS. | Perm | CM | CLAS | 17 | SDTM Interventions | CM | |
| CMCLASCD | Medication Class Code | Char | Variable Qualifier | Class code corresponding to CMCLAS. Drug class. May be obtained from coding. When coding to a single class, populate with class code. If using a dictionary and coding to multiple classes, then populate multiple values per TIG guidance or omit CMCLASCD. | Perm | CM | CLASCD | 18 | SDTM Interventions | CM | |
| CMDOSE | Dose per Administration | Num | Record Qualifier | Amount of CMTRT given. Not populated when CMDOSTXT is populated. | Perm | CM | DOSE | 19 | SDTM Interventions | CM | |
| CMDOSTXT | Dose Description | Char | Record Qualifier | Dosing amounts or a range of dosing information collected in text form. Units may be stored in CMDOSU. Examples: "200-400", "15-20". Not populated when CMDOSE is populated. | Perm | CM | DOSTXT | 20 | SDTM Interventions | CM | |
| CMDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for CMDOSE, CMDOSTOT, or CMDOSTXT. Examples: "ng", "mg", "mg/kg". | Perm | CM | DOSU | 21 | SDTM Interventions | CM |
| CMDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for CMTRT. Examples: "TABLET", "LOTION". | Perm | CM | DOSFRM | 22 | SDTM Interventions | CM |
| CMDOSFRQ | Dosing Frequency per Interval | Char | (FREQ) | Record Qualifier | Usually expressed as the number of repeated administrations of CMDOSE within a specific time period. Examples: "BID" (twice daily), "Q12H" (every 12 hours). | Perm | CM | DOSFRQ | 23 | SDTM Interventions | CM |
| CMDOSTOT | Total Daily Dose | Num | Record Qualifier | Total daily dose of CMTRT using the units in CMDOSU. Used when dosing is collected as total daily dose. Total dose over a period other than day could be recorded in a separate supplemental qualifier variable. | Perm | CM | DOSTOT | 24 | SDTM Interventions | CM | |
| CMDOSRGM | Intended Dose Regimen | Char | Record Qualifier | Text description of the (intended) schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF". | Perm | CM | DOSRGM | 25 | SDTM Interventions | CM | |
| CMROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS". | Perm | CM | ROUTE | 26 | SDTM Interventions | CM |
| CMADJ | Reason for Dose Adjustment | Char | Record Qualifier | Describes reason or explanation of why a dose is adjusted. Examples: "ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON". | Perm | CM | ADJ | 27 | SDTM Interventions | CM | |
| CMRSDISC | Reason the Intervention Was Discontinued | Char | Record Qualifier | When dosing of a treatment is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the treatment. | Perm | CM | RSDISC | 28 | SDTM Interventions | CM | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm for the element in which the medication administration started. Null for medications that started before study participation. | Perm | CM | TAETORD | 29 | SDTM Interventions | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the medication administration. Null for medications that started before study participation. | Perm | CM | EPOCH | 30 | SDTM Interventions | |
| CMSTDTC | Start Date/Time of Medication | Char | ISO 8601 datetime or interval | Timing | Start date/time of the medication administration represented in ISO 8601 character format. | Perm | CM | STDTC | 31 | SDTM Interventions | CM |
| CMENDTC | End Date/Time of Medication | Char | ISO 8601 datetime or interval | Timing | End date/time of the medication administration represented in ISO 8601 character format. | Perm | CM | ENDTC | 32 | SDTM Interventions | CM |
| CMSTDY | Study Day of Start of Medication | Num | Timing | Study day of start of medication relative to the applicant-defined RFSTDTC. | Perm | CM | STDY | 33 | SDTM Interventions | CM | |
| CMENDY | Study Day of End of Medication | Num | Timing | Study day of end of medication relative to the applicant-defined RFSTDTC. | Perm | CM | ENDY | 34 | SDTM Interventions | CM | |
| CMDUR | Duration | Char | ISO 8601 duration | Timing | Collected duration for a treatment episode. Used only if collected on the CRF and not derived from start and end date/times. | Perm | CM | DUR | 35 | SDTM Interventions | CM |
| CMSTRF | Start Relative to Reference Period | Char | (STENRF) | Timing | Describes the start of the medication relative to applicant-defined reference period. The applicant-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). If information such as "PRIOR" was collected, this information may be translated into CMSTRF. | Perm | CM | STRF | 36 | SDTM Interventions | CM |
| CMENRF | End Relative to Reference Period | Char | (STENRF) | Timing | Describes the end of the medication relative to the applicant-defined reference period. The applicant-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). If information such as "PRIOR", "ONGOING, or "CONTINUING" was collected, this information may be translated into CMENRF. | Perm | CM | ENRF | 37 | SDTM Interventions | CM |
| CMSTRTPT | Start Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the start of the medication as being before or after the applicant-defined reference time point defined by variable CMSTTPT. | Perm | CM | STRTPT | 38 | SDTM Interventions | CM |
| CMSTTPT | Start Reference Time Point | Char | Timing | Description or date/time in ISO 8601 character format of the applicant-defined reference point referred to by CMSTRTPT. Examples: "2003-12-15", "VISIT 1". | Perm | CM | STTPT | 39 | SDTM Interventions | CM | |
| CMENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the end of the medication as being before or after the applicant-defined reference time point defined by variable CMENTPT. | Perm | CM | ENRTPT | 40 | SDTM Interventions | CM |
| CMENTPT | End Reference Time Point | Char | Timing | Description or date/time in ISO 8601 character format of the applicant-defined reference point referred to by CMENRTPT. Examples: "2003-12-25", "VISIT 2". | Perm | CM | ENTPT | 41 | SDTM Interventions | CM | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | SU | STUDYID | 1 | SDTM Interventions | ||
| DOMAIN | Domain Abbreviation | Char | SU | Identifier | Two-character abbreviation for the domain. | Req | SU | DOMAIN | 2 | SDTM Interventions | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | SU | USUBJID | 3 | SDTM Interventions | ||
| SUSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | SU | SEQ | 4 | SDTM Interventions | SU | |
| SUGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | SU | GRPID | 5 | SDTM Interventions | SU | |
| SUSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a Tobacco & Alcohol Use CRF page. | Perm | SU | SPID | 6 | SDTM Interventions | SU | |
| SUTRT | Reported Name of Substance | Char | Topic | Substance name. Examples: "CIGARETTES", "COFFEE". | Req | SU | TRT | 7 | SDTM Interventions | SU | |
| SUMODIFY | Modified Substance Name | Char | Synonym Qualifier | If SUTRT is modified, then the modified text is placed here. | Perm | SU | MODIFY | 8 | SDTM Interventions | SU | |
| SUDECOD | Standardized Substance Name | Char | Synonym Qualifier | Standardized or dictionary-derived text description of SUTRT or SUMODIFY if the applicant chooses to code the substance use. | Perm | SU | DECOD | 9 | SDTM Interventions | SU | |
| SUCAT | Category for Substance Use | Char | Grouping Qualifier | Used to define a category of related records. Examples: "TOBACCO", "ALCOHOL", or "CAFFEINE". | Perm | SU | CAT | 10 | SDTM Interventions | SU | |
| SUSCAT | Subcategory for Substance Use | Char | Grouping Qualifier | A further categorization of substance use. Examples: "CIGARS", "CIGARETTES", "BEER", "WINE". | Perm | SU | SCAT | 11 | SDTM Interventions | SU | |
| SUPRESP | SU Pre-Specified | Char | (NY) | Variable Qualifier | Used to indicate whether ("Y"/null) information about the use of a specific substance was solicited on the CRF. | Perm | SU | PRESP | 12 | SDTM Interventions | SU |
| SUOCCUR | SU Occurrence | Char | (NY) | Record Qualifier | When the use of specific substances is solicited, SUOCCUR is used to indicate whether ("Y"/"N") a particular prespecified substance was used. Values are null for substances not specifically solicited. | Perm | SU | OCCUR | 13 | SDTM Interventions | SU |
| SUSTAT | Completion Status | Char | (ND) | Record Qualifier | When the use of prespecified substances is solicited, the completion status indicates that there was no response to the question about the prespecified substance. When there is no prespecified list on the CRF, then the completion status indicates that substance use was not assessed for the subject. | Perm | SU | STAT | 14 | SDTM Interventions | SU |
| SUREASND | Reason Substance Use Not Collected | Char | Record Qualifier | Describes the reason substance use was not collected. Used in conjunction with SUSTAT when value of SUSTAT is "NOT DONE". | Perm | SU | REASND | 15 | SDTM Interventions | SU | |
| SUCLAS | Substance Use Class | Char | Variable Qualifier | Substance use class. May be obtained from coding. When coding to a single class, populate with class value. If using a dictionary and coding to multiple classes, then follow Section 4.2.8.3, Multiple Values for a Non-result Qualifier Variable, or omit SUCLAS. | Perm | SU | CLAS | 16 | SDTM Interventions | SU | |
| SUCLASCD | Substance Use Class Code | Char | Variable Qualifier | Code corresponding to SUCLAS. May be obtained from coding. | Perm | SU | CLASCD | 17 | SDTM Interventions | SU | |
| SUDOSE | Substance Use Consumption | Num | Record Qualifier | Amount of SUTRT consumed. Not populated if SUDOSTXT is populated. | Perm | SU | DOSE | 18 | SDTM Interventions | SU | |
| SUDOSTXT | Substance Use Consumption Text | Char | Record Qualifier | Substance use consumption amounts or a range of consumption information collected in text form. Not populated if SUDOSE is populated. | Perm | SU | DOSTXT | 19 | SDTM Interventions | SU | |
| SUDOSU | Consumption Units | Char | (UNIT) | Variable Qualifier | Units for SUDOSE, SUDOSTOT, or SUDOSTXT. Examples: "oz", "CIGARETTE", "PACK", "g". | Perm | SU | DOSU | 20 | SDTM Interventions | SU |
| SUDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for SUTRT. Examples: "INJECTABLE", "LIQUID", "POWDER". | Perm | SU | DOSFRM | 21 | SDTM Interventions | SU |
| SUDOSFRQ | Use Frequency Per Interval | Char | (FREQ) | Variable Qualifier | Usually expressed as the number of repeated administrations of SUDOSE within a specific time period. Example: "Q24H" (every day). | Perm | SU | DOSFRQ | 22 | SDTM Interventions | SU |
| SUDOSTOT | Total Daily Consumption | Num | Record Qualifier | Total daily use of SUTRT using the units in SUDOSU. Used when dosing is collected as total daily dose. If an applicant needs to aggregate the data over a period other than daily, then the aggregated total could be recorded in a supplemental qualifier variable. | Perm | SU | DOSTOT | 23 | SDTM Interventions | SU | |
| SUROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for SUTRT. Examples: "ORAL", "INTRAVENOUS". | Perm | SU | ROUTE | 24 | SDTM Interventions | SU |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the arm for the element in which the substance use started. Null for substances that started before study participation. | Perm | SU | TAETORD | 25 | SDTM Interventions | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the substance use. Null for substances that started before study participation. | Perm | SU | EPOCH | 26 | SDTM Interventions | |
| SUSTDTC | Start Date/Time of Substance Use | Char | ISO 8601 datetime or interval | Timing | Start date/time of the substance use represented in ISO 8601 character format. | Perm | SU | STDTC | 27 | SDTM Interventions | SU |
| SUENDTC | End Date/Time of Substance Use | Char | ISO 8601 datetime or interval | Timing | End date/time of the substance use represented in ISO 8601 character format. | Perm | SU | ENDTC | 28 | SDTM Interventions | SU |
| SUSTDY | Study Day of Start of Substance Use | Num | Timing | Study day of start of substance use relative to the applicant-defined RFSTDTC. | Perm | SU | STDY | 29 | SDTM Interventions | SU | |
| SUENDY | Study Day of End of Substance Use | Num | Timing | Study day of end of substance use relative to the applicant-defined RFSTDTC. | Perm | SU | ENDY | 30 | SDTM Interventions | SU | |
| SUDUR | Duration of Substance Use | Char | ISO 8601 duration | Timing | Collected duration of substance use in ISO 8601 format. Used only if collected on the CRF and not derived from start and end date/times. | Perm | SU | DUR | 31 | SDTM Interventions | SU |
| SUSTRF | Start Relative to Reference Period | Char | (STENRF) | Timing | Describes the start of the substance use relative to the applicant-defined reference period. The applicant-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). If information such as "PRIOR" was collected, this information may be translated into SUSTRF. | Perm | SU | STRF | 32 | SDTM Interventions | SU |
| SUENRF | End Relative to Reference Period | Char | (STENRF) | Timing | Describes the end of the substance use with relative to the applicant-defined reference period. The applicant-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). If information such as "PRIOR", "ONGOING", or "CONTINUING" was collected, this information may be translated into SUENRF. | Perm | SU | ENRF | 33 | SDTM Interventions | SU |
| SUSTRTPT | Start Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the start of the substance as being before or after the reference time point defined by variable SUSTTPT. | Perm | SU | STRTPT | 34 | SDTM Interventions | SU |
| SUSTTPT | Start Reference Time Point | Char | Timing | Description or date/time in ISO 8601 character format of the reference point referred to by SUSTRTPT. Examples: "2003-12-15", "VISIT 1". | Perm | SU | STTPT | 35 | SDTM Interventions | SU | |
| SUENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the end of the substance as being before or after the reference time point defined by variable SUENTPT. | Perm | SU | ENRTPT | 36 | SDTM Interventions | SU |
| SUENTPT | End Reference Time Point | Char | Timing | Description or date/time in ISO 8601 character format of the reference point referred to by SUENRTPT. Examples: "2003-12-25", "VISIT 2". | Perm | SU | ENTPT | 37 | SDTM Interventions | SU | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | EX | STUDYID | 1 | SDTM Interventions | ||
| DOMAIN | Domain Abbreviation | Char | EX | Identifier | Two-character abbreviation for the domain. | Req | EX | DOMAIN | 2 | SDTM Interventions | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | EX | USUBJID | 3 | SDTM Interventions | ||
| EXSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | EX | SEQ | 4 | SDTM Interventions | EX | |
| EXGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | EX | GRPID | 5 | SDTM Interventions | EX | |
| EXREFID | Reference ID | Char | Identifier | Internal or external identifier. | Perm | EX | REFID | 6 | SDTM Interventions | EX | |
| EXSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF Page. | Perm | EX | SPID | 7 | SDTM Interventions | EX | |
| EXLNKID | Link ID | Char | Identifier | Identifier used to link related records across domains. | Perm | EX | LNKID | 8 | SDTM Interventions | EX | |
| EXLNKGRP | Link Group ID | Char | Identifier | Identifier used to link related, grouped records across domains. | Perm | EX | LNKGRP | 9 | SDTM Interventions | EX | |
| EXTRT | Name of Product | Char | Topic | Name of the protocol-specified study product given during the dosing period for the observation. | Req | EX | TRT | 10 | SDTM Interventions | EX | |
| EXCAT | Category of Product | Char | Grouping Qualifier | Used to define a category of EXTRT values. | Perm | EX | CAT | 11 | SDTM Interventions | EX | |
| EXSCAT | Subcategory of Product | Char | Grouping Qualifier | A further categorization of EXCAT values. | Perm | EX | SCAT | 12 | SDTM Interventions | EX | |
| EXDOSE | Dose | Num | Record Qualifier | Amount of EXTRT when numeric. Not populated when EXDOSTXT is populated. | Exp | EX | DOSE | 13 | SDTM Interventions | EX | |
| EXDOSTXT | Dose Description | Char | Record Qualifier | Amount of EXTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: 200-400. Not populated when EXDOSE is populated. | Perm | EX | DOSTXT | 14 | SDTM Interventions | EX | |
| EXDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified values. Examples: "ng", "mg", "mg/kg", "mg/m2". | Exp | EX | DOSU | 15 | SDTM Interventions | EX |
| EXDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for EXTRT. | Exp | EX | DOSFRM | 16 | SDTM Interventions | EX |
| EXDOSFRQ | Dosing Frequency per Interval | Char | (FREQ) | Variable Qualifier | Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. | Perm | EX | DOSFRQ | 17 | SDTM Interventions | EX |
| EXDOSRGM | Intended Dose Regimen | Char | Variable Qualifier | Text description of the intended schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF". | Perm | EX | DOSRGM | 18 | SDTM Interventions | EX | |
| EXROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for the intervention. Examples: "ORAL". | Perm | EX | ROUTE | 19 | SDTM Interventions | EX |
| EXLOT | Lot Number | Char | Record Qualifier | Lot number of the intervention product. | Perm | EX | LOT | 20 | SDTM Interventions | EX | |
| EXLOC | Location of Dose Administration | Char | (LOC) | Record Qualifier | Specifies location of administration. Examples: "ARM", "LIP". | Perm | EX | LOC | 21 | SDTM Interventions | EX |
| EXLAT | Laterality | Char | (LAT) | Variable Qualifier | Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT". | Perm | EX | LAT | 22 | SDTM Interventions | EX |
| EXDIR | Directionality | Char | (DIR) | Variable Qualifier | Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER". | Perm | EX | DIR | 23 | SDTM Interventions | EX |
| EXFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. Examples: "Y", "N". | Perm | EX | FAST | 24 | SDTM Interventions | EX |
| EXADJ | Reason for Dose Adjustment | Char | Record Qualifier | Describes reason or explanation of why a dose is adjusted. | Perm | EX | ADJ | 25 | SDTM Interventions | EX | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | EX | TAETORD | 26 | SDTM Interventions | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Study Epoch of the Exposure record. Examples: "RUN-IN", "FOLLOW-UP". | Perm | EX | EPOCH | 27 | SDTM Interventions | |
| EXSTDTC | Start Date/Time of Exposure | Char | ISO 8601 datetime or interval | Timing | The date/time when administration of the product indicated by EXTRT and EXDOSE began. | Exp | EX | STDTC | 28 | SDTM Interventions | EX |
| EXENDTC | End Date/Time of Exposure | Char | ISO 8601 datetime or interval | Timing | The date/time when administration of the product indicated by EXTRT and EXDOSE ended. For administrations considered given at a point in time, where only an administration date/time is collected, EXSTDTC should be copied to EXENDTC as the standard representation. | Exp | EX | ENDTC | 29 | SDTM Interventions | EX |
| EXSTDY | Study Day of Start of Exposure | Num | Timing | Study day of EXSTDTC relative to DM.RFSTDTC. | Perm | EX | STDY | 30 | SDTM Interventions | EX | |
| EXENDY | Study Day of End of Exposure | Num | Timing | Study day of EXENDTC relative to DM.RFSTDTC. | Perm | EX | ENDY | 31 | SDTM Interventions | EX | |
| EXDUR | Duration of Exposure | Char | ISO 8601 duration | Timing | Collected duration of administration. Used only if collected on the CRF and not derived from start and end date/times. | Perm | EX | DUR | 32 | SDTM Interventions | EX |
| EXTPT | Planned Time Point Name | Char | Timing | 1. Text Description of time when administration should occur. \n 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EXTPTNUM and EXTPTREF. | Perm | EX | TPT | 33 | SDTM Interventions | EX | |
| EXTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EXTPT to aid in sorting. | Perm | EX | TPTNUM | 34 | SDTM Interventions | EX | |
| EXELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time. | Perm | EX | ELTM | 35 | SDTM Interventions | EX |
| EXTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EXELTM, EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE. | Perm | EX | TPTREF | 36 | SDTM Interventions | EX | |
| EXRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time for a fixed reference time point defined by EXTPTREF. | Perm | EX | RFTDTC | 37 | SDTM Interventions | EX |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | EC | STUDYID | 1 | SDTM Interventions | ||
| DOMAIN | Domain Abbreviation | Char | EC | Identifier | Two-character abbreviation for the domain. | Req | EC | DOMAIN | 2 | SDTM Interventions | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | EC | USUBJID | 3 | SDTM Interventions | ||
| ECSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | EC | SEQ | 4 | SDTM Interventions | EC | |
| ECGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | EC | GRPID | 5 | SDTM Interventions | EC | |
| ECREFID | Reference ID | Char | Identifier | Internal or external identifier (e.g., kit number, bottle label, vial identifier). | Perm | EC | REFID | 6 | SDTM Interventions | EC | |
| ECSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF Page. | Perm | EC | SPID | 7 | SDTM Interventions | EC | |
| ECLNKID | Link ID | Char | Identifier | Identifier used to link related records across domains. | Perm | EC | LNKID | 8 | SDTM Interventions | EC | |
| ECLNKGRP | Link Group ID | Char | Identifier | Identifier used to link related, grouped records across domains. | Perm | EC | LNKGRP | 9 | SDTM Interventions | EC | |
| ECTRT | Name of Product | Char | Topic | Name of the product known to the subject and/or administrator. | Req | EC | TRT | 10 | SDTM Interventions | EC | |
| ECMOOD | Mood | Char | (BRDGMOOD) | Record Qualifier | Mode or condition of the record specifying whether the intervention (activity) is intended to happen or has happened. Values align with BRIDG pillars (e.g., scheduled context, performed context) and HL7 activity moods (e.g., intent, event). Examples: "SCHEDULED", "PERFORMED". | Perm | EC | MOOD | 11 | SDTM Interventions | EC |
| ECCAT | Category of Product | Char | Grouping Qualifier | Used to define a category of related ECTRT values. | Perm | EC | CAT | 12 | SDTM Interventions | EC | |
| ECSCAT | Subcategory of Product | Char | Grouping Qualifier | A further categorization of ECCAT values. | Perm | EC | SCAT | 13 | SDTM Interventions | EC | |
| ECPRESP | Pre-Specified | Char | (NY) | Variable Qualifier | Used when a specific intervention is pre-specified. Values should be "Y" or null. | Perm | EC | PRESP | 14 | SDTM Interventions | EC |
| ECOCCUR | Occurrence | Char | (NY) | Record Qualifier | Used to indicate whether an exposure occurred when information about the occurrence is solicited. ECOCCUR = "N" when a product was not taken, not given, or missed. | Perm | EC | OCCUR | 15 | SDTM Interventions | EC |
| ECDOSE | Dose | Num | Record Qualifier | Amount of ECTRT when numeric. Not populated when ECDOSTXT is populated. | Exp | EC | DOSE | 16 | SDTM Interventions | EC | |
| ECDOSTXT | Dose Description | Char | Record Qualifier | Amount of ECTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: "200-400". Not populated when ECDOSE is populated. | Perm | EC | DOSTXT | 17 | SDTM Interventions | EC | |
| ECDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for ECDOSE, ECDOSTOT, or ECDOSTXT. | Exp | EC | DOSU | 18 | SDTM Interventions | EC |
| ECDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for ECTRT. | Exp | EC | DOSFRM | 19 | SDTM Interventions | EC |
| ECDOSFRQ | Dosing Frequency per Interval | Char | (FREQ) | Variable Qualifier | Usually expressed as the number of repeated administrations of ECDOSE within a specific time period. Examples: "Q2H", "QD", "BID". | Perm | EC | DOSFRQ | 20 | SDTM Interventions | EC |
| ECDOSTOT | Total Daily Dose | Num | Record Qualifier | Total daily dose of ECTRT using the units in ECDOSU. Used when dosing is collected as Total Daily Dose. | Perm | EC | DOSTOT | 21 | SDTM Interventions | EC | |
| ECDOSRGM | Intended Dose Regimen | Char | Variable Qualifier | Text description of the intended schedule or regimen for the Intervention. Example: "TWO WEEKS ON", "TWO WEEKS OFF". | Perm | EC | DOSRGM | 22 | SDTM Interventions | EC | |
| ECROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for the intervention. Examples: "ORAL". | Perm | EC | ROUTE | 23 | SDTM Interventions | EC |
| ECLOT | Lot Number | Char | Record Qualifier | Lot Number of the ECTRT product. | Perm | EC | LOT | 24 | SDTM Interventions | EC | |
| ECLOC | Location of Dose Administration | Char | (LOC) | Record Qualifier | Specifies location of administration. Example: "ARM", "LIP". | Perm | EC | LOC | 25 | SDTM Interventions | EC |
| ECLAT | Laterality | Char | (LAT) | Variable Qualifier | Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT". | Perm | EC | LAT | 26 | SDTM Interventions | EC |
| ECDIR | Directionality | Char | (DIR) | Variable Qualifier | Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER". | Perm | EC | DIR | 27 | SDTM Interventions | EC |
| ECPORTOT | Portion or Totality | Char | (PORTOT) | Variable Qualifier | Qualifier for anatomical location further detailing distribution, which means arrangement of, apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT". | Perm | EC | PORTOT | 28 | SDTM Interventions | EC |
| ECPSTRG | Pharmaceutical Strength | Num | Record Qualifier | Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. | Perm | EC | PSTRG | 29 | SDTM Interventions | EC | |
| ECPSTRGU | Pharmaceutical Strength Units | Char | Variable Qualifier | Unit for ECPSTRG. Examples: "mg/TABLET", "mg/mL". | Perm | EC | PSTRGU | 30 | SDTM Interventions | EC | |
| ECADJ | Reason for Dose Adjustment | Char | Record Qualifier | Describes reason or explanation of why a dose is adjusted. | Perm | EC | ADJ | 31 | SDTM Interventions | EC | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | EC | TAETORD | 32 | SDTM Interventions | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Trial Epoch of the exposure as collected record. Examples: "RUN-IN". | Perm | EC | EPOCH | 33 | SDTM Interventions | |
| ECSTDTC | Start Date/Time of Exposure | Char | ISO 8601 datetime or interval | Timing | The date/time when administration of the product indicated by ECTRT and ECDOSE began. | Exp | EC | STDTC | 34 | SDTM Interventions | EC |
| ECENDTC | End Date/Time of Exposure | Char | ISO 8601 datetime or interval | Timing | The date/time when administration of the product indicated by ECTRT and ECDOSE ended. For administrations considered given at a point in time (e.g., oral tablet, pre-filled syringe injection), where only an administration date/time is collected, ECSTDTC should be copied to ECENDTC as the standard representation. | Exp | EC | ENDTC | 35 | SDTM Interventions | EC |
| ECSTDY | Study Day of Start of Exposure | Num | Timing | Study day of ECSTDTC relative to the applicant-defined DM.RFSTDTC. | Perm | EC | STDY | 36 | SDTM Interventions | EC | |
| ECENDY | Study Day of End Exposure | Num | Timing | Study day of ECENDTC relative to the applicant-defined DM.RFSTDTC. | Perm | EC | ENDY | 37 | SDTM Interventions | EC | |
| ECDUR | Duration of Exposure | Char | ISO 8601 duration | Timing | Collected duration of administration. Used only if collected on the CRF and not derived from start and end date/times. | Perm | EC | DUR | 38 | SDTM Interventions | EC |
| ECTPT | Planned Time Point Name | Char | Timing | Text Description of time when administration should occur. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See ECTPTNUM and ECTPTREF. | Perm | EC | TPT | 39 | SDTM Interventions | EC | |
| ECTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of ECTPT to aid in sorting. | Perm | EC | TPTNUM | 40 | SDTM Interventions | EC | |
| ECELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time relative to the planned fixed reference (ECTPTREF). This variable is useful where there are repetitive measures. Not a clock time. | Perm | EC | ELTM | 41 | SDTM Interventions | EC |
| ECTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by ECELTM, ECTPTNUM, and ECTPT. Examples: PREVIOUS DOSE. | Perm | EC | TPTREF | 42 | SDTM Interventions | EC | |
| ECRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time for a fixed reference time point defined by ECTPTREF. | Perm | EC | RFTDTC | 43 | SDTM Interventions | EC |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | RELREC | STUDYID | 1 | SDTM Relationship | ||
| RDOMAIN | Related Domain Abbreviation | Char | (DOMAIN) | Identifier | Abbreviation for the domain of the parent record(s). | Req | RELREC | RDOMAIN | 2 | SDTM Relationship | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Exp | RELREC | USUBJID | 3 | SDTM Relationship | ||
| IDVAR | Identifying Variable | Char | Identifier | Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID. | Req | RELREC | IDVAR | 4 | SDTM Relationship | ||
| IDVARVAL | Identifying Variable Value | Char | Identifier | Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here. | Exp | RELREC | IDVARVAL | 5 | SDTM Relationship | ||
| RELTYPE | Relationship Type | Char | (RELTYPE) | Record Qualifier | Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. Used only when identifying a relationship between datasets). | Exp | RELREC | RELTYPE | 6 | SDTM Relationship | |
| RELID | Relationship Identifier | Char | Record Qualifier | Unique value within USUBJID that identifies the relationship. All records for the same USUBJID that have the same RELID are considered "related/associated." RELID can be any value the applicant chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records. | Req | RELREC | RELID | 7 | SDTM Relationship | ||
| STUDYID | Study Identifier | Char | Identifier | Study identifier of the parent record(s). | Req | SUPPQUAL | STUDYID | 1 | SDTM Relationship | ||
| RDOMAIN | Related Domain Abbreviation | Char | (DOMAIN) | Identifier | Two-character abbreviation for the domain of the parent record(s). | Req | SUPPQUAL | RDOMAIN | 2 | SDTM Relationship | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Unique subject identifier of the parent record(s). | Req | SUPPQUAL | USUBJID | 3 | SDTM Relationship | ||
| IDVAR | Identifying Variable | Char | Identifier | Identifying variable in the dataset that identifies the related record(s). Examples: --SEQ, --GRPID. | Exp | SUPPQUAL | IDVAR | 4 | SDTM Relationship | ||
| IDVARVAL | Identifying Variable Value | Char | Identifier | Value of identifying variable of the parent record(s). | Exp | SUPPQUAL | IDVARVAL | 5 | SDTM Relationship | ||
| QNAM | Qualifier Variable Name | Char | Topic | The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the applicant's operational dataset. | Req | SUPPQUAL | QNAM | 6 | SDTM Relationship | ||
| QLABEL | Qualifier Variable Label | Char | Synonym Qualifier | This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the applicant's original dataset. | Req | SUPPQUAL | QLABEL | 7 | SDTM Relationship | ||
| QVAL | Data Value | Char | Result Qualifier | Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in SUPP-- with a null value for QVAL. | Req | SUPPQUAL | QVAL | 8 | SDTM Relationship | ||
| QORIG | Origin | Char | Record Qualifier | Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. | Req | SUPPQUAL | QORIG | 9 | SDTM Relationship | ||
| QEVAL | Evaluator | Char | Record Qualifier | Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include "ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR", etc. | Exp | SUPPQUAL | QEVAL | 10 | SDTM Relationship | ||
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | CO | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | CO | Identifier | Two-character abbreviation for the domain. | Req | CO | DOMAIN | 2 | SDTM Special-Purpose | |
| RDOMAIN | Related Domain Abbreviation | Char | (DOMAIN) | Record Qualifier | Two-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page. | Perm | CO | RDOMAIN | 3 | SDTM Special-Purpose | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | CO | USUBJID | 4 | SDTM Special-Purpose | ||
| COSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | CO | SEQ | 5 | SDTM Special-Purpose | CO | |
| IDVAR | Identifying Variable | Char | Record Qualifier | Identifying variable in the parent dataset that identifies the record(s) to which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments are related to domain records. Null for comments collected on separate CRFs. | Perm | CO | IDVAR | 6 | SDTM Special-Purpose | ||
| IDVARVAL | Identifying Variable Value | Char | Record Qualifier | Value of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs. | Perm | CO | IDVARVAL | 7 | SDTM Special-Purpose | ||
| COREF | Comment Reference | Char | Record Qualifier | Applicant-defined reference associated with the comment. May be the CRF page number (e.g., 650), or a module name (e.g., DEMOG), or a combination of information that identifies the reference (e.g. 650-VITALS-VISIT 2). | Perm | CO | REF | 8 | SDTM Special-Purpose | CO | |
| COVAL | Comment | Char | Topic | The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. | Req | CO | VAL | 9 | SDTM Special-Purpose | CO | |
| COEVAL | Evaluator | Char | (EVAL) | Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Example: "INVESTIGATOR". | Perm | CO | EVAL | 10 | SDTM Special-Purpose | CO |
| COEVALID | Evaluator Identifier | Char | (MEDEVAL) | Record Qualifier | Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: "RADIOLOGIST", "RADIOLOGIST 1", "RADIOLOGIST 2". | Perm | CO | EVALID | 11 | SDTM Special-Purpose | CO |
| CODTC | Date/Time of Comment | Char | ISO 8601 datetime or interval | Timing | Date/time of comment on dedicated comment form. Should be null if this is a child record of another domain or if comment date was not collected. | Perm | CO | DTC | 12 | SDTM Special-Purpose | CO |
| CODY | Study Day of Comment | Num | Timing | Study day of the comment, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | CO | DY | 13 | SDTM Special-Purpose | CO | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DM | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | DM | Identifier | Two-character abbreviation for the domain. | Req | DM | DOMAIN | 2 | SDTM Special-Purpose | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. This must be a unique value, and could be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID. | Req | DM | USUBJID | 3 | SDTM Special-Purpose | ||
| SUBJID | Subject Identifier for the Study | Char | Topic | Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF. | Req | DM | SUBJID | 4 | SDTM Special-Purpose | ||
| RFSTDTC | Subject Reference Start Date/Time | Char | ISO 8601 datetime or interval | Record Qualifier | Reference start date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study product. | Exp | DM | RFSTDTC | 5 | SDTM Special-Purpose | |
| RFENDTC | Subject Reference End Date/Time | Char | ISO 8601 datetime or interval | Record Qualifier | Reference end date/time for the subject in ISO 8601 character format. Usually equivalent to the date/time when subject was determined to have ended the study/trial, and often equivalent to date/time of last exposure to study product. Required for all randomized subjects; null for screen failures or unassigned subjects. | Exp | DM | RFENDTC | 6 | SDTM Special-Purpose | |
| RFXSTDTC | Date/Time of First Study Exposure | Char | ISO 8601 datetime or interval | Record Qualifier | First date/time of exposure to any protocol-specified product, equal to the earliest value of EXSTDTC. | Exp | DM | RFXSTDTC | 7 | SDTM Special-Purpose | |
| RFXENDTC | Date/Time of Last Study Exposure | Char | ISO 8601 datetime or interval | Record Qualifier | Last date/time of exposure to any protocol-specified product, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). | Exp | DM | RFXENDTC | 8 | SDTM Special-Purpose | |
| RFICDTC | Date/Time of Informed Consent | Char | ISO 8601 datetime or interval | Record Qualifier | Date/time of informed consent in ISO 8601 character format. This will be the same as the date of informed consent in the Disposition domain, if that protocol milestone is documented. Would be null only in studies not collecting the date of informed consent. | Exp | DM | RFICDTC | 9 | SDTM Special-Purpose | |
| RFPENDTC | Date/Time of End of Participation | Char | ISO 8601 datetime or interval | Record Qualifier | Date/time when subject ended participation or follow-up in a study/trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples include completion date, withdrawal date, last follow-up, date recorded for lost to follow up, and death date. | Exp | DM | RFPENDTC | 10 | SDTM Special-Purpose | |
| DTHDTC | Date/Time of Death | Char | ISO 8601 datetime or interval | Record Qualifier | Date/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-study database. | Exp | DM | DTHDTC | 11 | SDTM Special-Purpose | |
| DTHFL | Subject Death Flag | Char | (NY) | Record Qualifier | Indicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown. | Exp | DM | DTHFL | 12 | SDTM Special-Purpose | |
| SITEID | Study Site Identifier | Char | Record Qualifier | Unique identifier for a site within a study. | Req | DM | SITEID | 13 | SDTM Special-Purpose | ||
| INVID | Investigator Identifier | Char | Record Qualifier | An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID. | Perm | DM | INVID | 14 | SDTM Special-Purpose | ||
| INVNAM | Investigator Name | Char | Synonym Qualifier | Name of the investigator for a site. | Perm | DM | INVNAM | 15 | SDTM Special-Purpose | ||
| BRTHDTC | Date/Time of Birth | Char | ISO 8601 datetime or interval | Record Qualifier | Date/time of birth of the subject. | Perm | DM | BRTHDTC | 16 | SDTM Special-Purpose | |
| AGE | Age | Num | Record Qualifier | Age expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns). | Exp | DM | AGE | 17 | SDTM Special-Purpose | ||
| AGEU | Age Units | Char | (AGEU) | Variable Qualifier | Units associated with AGE. | Exp | DM | AGEU | 18 | SDTM Special-Purpose | |
| SEX | Sex | Char | (SEX) | Record Qualifier | Sex of the subject. | Req | DM | SEX | 19 | SDTM Special-Purpose | |
| RACE | Race | Char | (RACE) | Record Qualifier | Race of the subject. Race will be collected and represented per regulatory requirements. | Exp | DM | RACE | 20 | SDTM Special-Purpose | |
| ETHNIC | Ethnicity | Char | (ETHNIC) | Record Qualifier | The ethnicity of the subject. Ethnicity will be collected and represented per regulatory requirements. | Perm | DM | ETHNIC | 21 | SDTM Special-Purpose | |
| ARMCD | Planned Arm Code | Char | Record Qualifier | ARMCD is limited to 20 characters. It is not subject to the character restrictions that apply to TESTCD. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover studies/trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each product and separating hyphens, the length of ARMCD values would be 20. If the subject was not assigned to an arm, ARMCD is null and ARMNRS is populated. \n With the exception of studies which use multistage arm assignments, must be a value of ARMCD in the Trial Arms dataset. | Exp | DM | ARMCD | 22 | SDTM Special-Purpose | ||
| ARM | Description of Planned Arm | Char | Synonym Qualifier | Name of the arm to which the subject was assigned. If the subject was not assigned to an arm, ARM is null and ARMNRS is populated. \n With the exception of studies which use multistage arm assignments, must be a value of ARM in the Trial Arms dataset. | Exp | DM | ARM | 23 | SDTM Special-Purpose | ||
| ACTARMCD | Actual Arm Code | Char | Record Qualifier | Code of actual arm. ACTARMCD is limited to 20 characters. It is not subject to the character restrictions that apply to TESTCD. The maximum length of ACTARMCD is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover studies/trials. \n With the exception of studies which use multistage arm assignments, must be a value of ARMCD in the Trial Arms dataset. \n If the subject was not assigned to an arm or followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is populated. | Exp | DM | ACTARMCD | 24 | SDTM Special-Purpose | ||
| ACTARM | Description of Actual Arm | Char | Synonym Qualifier | Description of actual arm. \n With the exception of studies which use multistage arm assignments, must be a value of ARM in the Trial Arms dataset. \n If the subject was not assigned to an arm or followed a course not described by any planned arm, ACTARM is null and ARMNRS is populated. | Exp | DM | ACTARM | 25 | SDTM Special-Purpose | ||
| ARMNRS | Reason Arm and/or Actual Arm is Null | Char | (ARMNULRS) | Record Qualifier | A coded reason that arm variables (ARM and ARMCD) and/or actual arm variables (ACTARM and ACTARMCD) are null. Example: "SCREEN FAILURE". It is assumed that if the arm and actual arm variables are null, the same reason applies to both arm and actual arm. | Exp | DM | ARMNRS | 26 | SDTM Special-Purpose | |
| ACTARMUD | Description of Unplanned Actual Arm | Char | Record Qualifier | A description of actual product for a subject who did not receive the product described in one of the planned arms. | Exp | DM | ACTARMUD | 27 | SDTM Special-Purpose | ||
| COUNTRY | Country | Char | Record Qualifier | Country of the investigational site in which the subject participated in the study/trial. \n \n Generally represented using ISO 3166-1 Alpha-3. Regulatory agencies may require other terminologies; in such cases, follow regulatory requirements. | Req | DM | COUNTRY | 28 | SDTM Special-Purpose | ||
| DMDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date/time of demographic data collection. | Perm | DM | DTC | 29 | SDTM Special-Purpose | DM |
| DMDY | Study Day of Collection | Num | Timing | Study day of collection measured as integer days. | Perm | DM | DY | 30 | SDTM Special-Purpose | DM | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | IN | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | IN | Identifier | Two-character abbreviation for the domain. | Req | IN | DOMAIN | 2 | SDTM Special-Purpose | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | Req | IN | SPTOBID | 3 | SDTM Special-Purpose | ||
| IGDCMPID | Ingredient or Component Identifier | Char | Identifier | Identifier given to an ingredient, substance or component of a product. In IN, it must be a non-tobacco ingredient of the product represented in SPTOBID (e.g., "Cocoa Extract", "Cellulose Pulp"). | Req | IN | IGDCMPID | 4 | SDTM Special-Purpose | ||
| INMANUF | Manufacturer Name | Char | Identifier | The name of the manufacturer of a complex ingredient/component represented in IGDCMPID. Does not need to be populated for single ingredients. | Perm | IN | MANUF | 5 | SDTM Special-Purpose | IN | |
| INMANUIN | Manufacturer Unique Identifying Item Num | Char | Identifier | The unique identifying item number assigned by the manufacturer to the ingredient or component shown in IGDCMPID (e.g, catalog number). | Perm | IN | MANUIN | 6 | SDTM Special-Purpose | IN | |
| TPMF | Tobacco Product Master File Number | Char | Identifier | The Tobacco Product Master File number for the ingredient/component represented in IGDCMPID, if applicable. Used for proprietary purchased ingredients when the manufacturer does not want to disclose the formula to the public and has instead provided these details in a file directly to regulators. | Perm | IN | TPMF | 7 | SDTM Special-Purpose | ||
| IUPACNAM | Preferred IUPAC Name | Char | IUPAC Nomenclature | Identifier | The preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in IGDCMPID, if applicable. | Exp | IN | IUPACNAM | 8 | SDTM Special-Purpose | |
| CASNO | CAS Registry Number | Char | CAS | Identifier | The Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID. | Perm | IN | CASNO | 9 | SDTM Special-Purpose | |
| UNII | Unique Ingredient Identifier | Char | UNII | Identifier | The FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in IGDCMPID. | Perm | IN | UNII | 10 | SDTM Special-Purpose | |
| INIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used to denote whether an ingredient is a single or complex ingredient (i.e.,., "SINGLE INGREDIENT", "COMPLEX INGREDIENT"). | Exp | IN | IGDPLX | 11 | SDTM Special-Purpose | IN |
| INCIGIND | Applicant-Customized Ingredient Indic | Char | (NY) | Record Qualifier | Used to indicate whether a complex ingredient was made to the applicant's specification. Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm | IN | CIGIND | 12 | SDTM Special-Purpose | IN |
| INGRADE | Ingredient Grade | Char | Record Qualifier | The grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD"). | Exp | IN | GRADE | 13 | SDTM Special-Purpose | IN | |
| INPURITY | Ingredient Purity | Char | Record Qualifier | The purity of the ingredient represented in IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%"). | Exp | IN | PURITY | 14 | SDTM Special-Purpose | IN | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | IQ | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | IQ | Identifier | Two-character abbreviation for the domain. | Req | IQ | DOMAIN | 2 | SDTM Special-Purpose | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | Req | IQ | SPTOBID | 3 | SDTM Special-Purpose | ||
| IGDCMPID | Ingredient or Component Identifier | Char | Identifier | Identifier given to an ingredient, substance or component of a tobacco product represented in SPTOBID. In IQ, it must match a value of IGDCMPID in either the IT dataset (if the ingredient is a tobacco ingredient) or IN (if the ingredient is a non-tobacco ingredient). \n (e.g., "Burley Tobacco", "Propylene Glycol", "Cocoa Extract", "Cellulose Pulp"). | Req | IQ | IGDCMPID | 4 | SDTM Special-Purpose | ||
| IQCAT | Category of Ingredient or Component | Char | (IQCAT) | Grouping Qualifier | Used to group ingredients/components by tobacco and non-tobacco ingredients. Required to enable conformance checks to ensure IGDCMPID is present in either the IT or IN domain. | Req | IQ | CAT | 5 | SDTM Special-Purpose | IQ |
| IQIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used to denote whether a ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT"). | Exp | IQ | IGDPLX | 6 | SDTM Special-Purpose | IQ |
| IQPARENT | Parent of Ingredient or Component | Char | Record Qualifier | Identifies the parent of which the ingredient or component represented in IGDCMPID is a part. (i.e, IGDCMPID is a child of the ingredient shown in IQPARENT). IQPARENT must equal a value of IGDCMPID from another record in the same dataset. IQPARENT will therefore always be a complex ingredient. If the ingredient is at the top level (i.e., it has no parent other than the tobacco product itself), IQPARENT will be null and IQLEVEL will be set to 1. (See IQLEVEL, below). | Perm | IQ | PARENT | 7 | SDTM Special-Purpose | IQ | |
| IQLEVEL | Ingredient Level in Hierarchy | Num | Record Qualifier | An integer that identifies the level of the ingredient or component within the hierarchy. The value of IQLEVEL will be n+1, where n is the IQLEVEL of the parent ingredient. IQLEVEL will be set to 1 If the ingredient is at the top level (i.e., if the ingredient has no parent ingredient/component other than the tobacco product itself). Must be populated when IQPARENT is populated. | Req | IQ | LEVEL | 8 | SDTM Special-Purpose | IQ | |
| IQFUNCT | Ingredient Function | Char | Record Qualifier | The function of the ingredient in the tobacco product or the parent component. (e.g., "Adhesive", "Flavorant"). | Exp | IQ | FUNCT | 9 | SDTM Special-Purpose | IQ | |
| IQVALTRG | Ingredient Target Value | Num | Result Qualifier | Target value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALTRG represents the target quantity within the parent component, not the overall quantity in the tobacco product. | Req | IQ | VALTRG | 10 | SDTM Special-Purpose | IQ | |
| IQVALMIN | Ingredient Minimum Value | Num | Result Qualifier | Minimum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMIN represents the minimum quantity within the parent component. | Exp | IQ | VALMIN | 11 | SDTM Special-Purpose | IQ | |
| IQVALMAX | Ingredient Maximum Value | Num | Result Qualifier | Maximum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMAX represents the maximum quantity within the parent component. | Exp | IQ | VALMAX | 12 | SDTM Special-Purpose | IQ | |
| IQVALU | Ingredient Value Unit | Char | (UNIT) | Result Qualifier | The single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX. | Exp | IQ | VALU | 13 | SDTM Special-Purpose | IQ |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | IT | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | IT | Identifier | Two-character abbreviation for the domain. | Req | IT | DOMAIN | 2 | SDTM Special-Purpose | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | Req | IT | SPTOBID | 3 | SDTM Special-Purpose | ||
| IGDCMPID | Ingredient or Component Identifier | Char | Identifier | Identifier given to an ingredient, substance or component of a tobacco product. In IT, it must be a tobacco ingredient of the product represented in SPTOBID (e.g., "Burley Tobacco", "Reconstituted Tobacco"). | Req | IT | IGDCMPID | 4 | SDTM Special-Purpose | ||
| TPMF | Tobacco Product Master File ID | Char | Identifier | The Tobacco Product Master File number, if applicable. | Perm | IT | TPMF | 5 | SDTM Special-Purpose | ||
| ITSPECIF | Specification or Variety of Tobacco Ingr | Char | Variable Qualifier | A qualifier of IGDCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC"). | Exp | IT | SPECIF | 6 | SDTM Special-Purpose | IT | |
| ITIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used to denote whether a tobacco ingredient is a single or complex ingredient (i.e., "SINGLE INGREDIENT" or "COMPLEX INGREDIENT"). | Exp | IT | IGDPLX | 7 | SDTM Special-Purpose | IT |
| ITCIGIND | Applicant-Customized Ingredient Indic | Char | (NY) | Record Qualifier | Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where ITIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm | IT | CIGIND | 8 | SDTM Special-Purpose | IT |
| ITCURMTH | Cure Method | Char | Record Qualifier | Method by which the tobacco ingredient is cured (e.g., "Air", "Sun", "Flue"). | Exp | IT | CURMTH | 9 | SDTM Special-Purpose | IT | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | PD | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | PD | Identifier | Two-character abbreviation for the domain. | Req | PD | DOMAIN | 2 | SDTM Special-Purpose | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | Req | PD | SPTOBID | 3 | SDTM Special-Purpose | ||
| IGDCMPID | Ingredient or Component Identifier | Char | Identifier | Identifier given to an ingredient, substance or component of a tobacco product .(e.g., "Burley Tobacco", "Reconstituted Tobacco"). It originates in the IT or IN domain. See PD assumption 2 below for more info. | Perm | PD | IGDCMPID | 4 | SDTM Special-Purpose | ||
| PDSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a design parameter within a tobacco product (SPTOBID) within the dataset. | Req | PD | SEQ | 5 | SDTM Special-Purpose | PD | |
| PDPARMCD | Design Parameter Element Short Name | Char | (PDPARMCD) | Topic | Short name of the parameter being described. Examples: "TOCUTSIZ", "BATCAPC". | Req | PD | PARMCD | 6 | SDTM Special-Purpose | PD |
| PDPARM | Design Parameter Element Name | Char | (PDPARM) | Synonym Qualifier | Name of the parameter being described. Examples: "Tobacco Cut Size", "Battery Capacity". | Req | PD | PARM | 7 | SDTM Special-Purpose | PD |
| PDVALTRG | Design Parameter Element Target Value | Char | Result Qualifier | Target value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID. | Req | PD | VALTRG | 8 | SDTM Special-Purpose | PD | |
| PDVALMIN | Design Parameter Element Minimum Value | Char | Result Qualifier | Minimum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID. | Exp | PD | VALMIN | 9 | SDTM Special-Purpose | PD | |
| PDVALMAX | Design Parameter Element Maximum Value | Char | Result Qualifier | Maximum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID. | Exp | PD | VALMAX | 10 | SDTM Special-Purpose | PD | |
| PDVALU | Design Parameter Element Value Unit | Char | (UNIT) | Result Qualifier | The single unit for the values in PDVALTRG, PDVALMIN and PDVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference"). | Perm | PD | VALU | 11 | SDTM Special-Purpose | PD |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | SE | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | SE | Identifier | Two-character abbreviation for the domain. | Req | SE | DOMAIN | 2 | SDTM Special-Purpose | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | SE | USUBJID | 3 | SDTM Special-Purpose | ||
| SESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. Should be assigned to be consistent chronological order. | Req | SE | SEQ | 4 | SDTM Special-Purpose | SE | |
| ETCD | Element Code | Char | Topic | 1. ETCD (the companion to ELEMENT) 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 ETCD will need to serve as a variable name. \n 2. If an encountered element differs from the planned element to the point that it is considered a new element, then use "UNPLAN" as the value for ETCD to represent this element. | Req | SE | ETCD | 5 | SDTM Special-Purpose | ||
| ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the element. If ETCD has a value of "UNPLAN", then ELEMENT should be null. | Perm | SE | ELEMENT | 6 | SDTM Special-Purpose | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the element within the subject's assigned trial arm. | Perm | SE | TAETORD | 7 | SDTM Special-Purpose | ||
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the element in the planned sequence of elements for the arm to which the subject was assigned. | Perm | SE | EPOCH | 8 | SDTM Special-Purpose | |
| SESTDTC | Start Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | Start date/time for an element for each subject. | Req | SE | STDTC | 9 | SDTM Special-Purpose | SE |
| SEENDTC | End Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | End date/time for an element for each subject. | Exp | SE | ENDTC | 10 | SDTM Special-Purpose | SE |
| SESTDY | Study Day of Start of Element | Num | Timing | Study day of start of element relative to the applicant-defined RFSTDTC. | Perm | SE | STDY | 11 | SDTM Special-Purpose | SE | |
| SEENDY | Study Day of End of Element | Num | Timing | Study day of end of element relative to the applicant-defined RFSTDTC. | Perm | SE | ENDY | 12 | SDTM Special-Purpose | SE | |
| SEUPDES | Description of Unplanned Element | Char | Synonym Qualifier | Description of what happened to the subject during an unplanned element. Used only if ETCD has the value of "UNPLAN". | Perm | SE | UPDES | 13 | SDTM Special-Purpose | SE | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | SV | STUDYID | 1 | SDTM Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | SV | Identifier | 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. | Req | SV | DOMAIN | 2 | SDTM Special-Purpose | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | SV | USUBJID | 3 | SDTM Special-Purpose | ||
| VISITNUM | Visit Number | Num | Topic | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Req | SV | VISITNUM | 4 | SDTM Special-Purpose | ||
| VISIT | Visit Name | Char | Synonym Qualifier | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Perm | SV | VISIT | 5 | SDTM Special-Purpose | ||
| SVPRESP | Pre-specified | Char | (NY) | Variable Qualifier | Used to indicate whether the visit was planned (i.e., visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned visits. | Exp | SV | PRESP | 6 | SDTM Special-Purpose | SV |
| SVOCCUR | Occurrence | Char | (NY) | Record Qualifier | Used to record whether a planned visit occurred. The value is null for unplanned visits. | Exp | SV | OCCUR | 7 | SDTM Special-Purpose | SV |
| SVREASOC | Reason for Occur Value | Char | Record Qualifier | The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur. | Perm | SV | REASOC | 8 | SDTM Special-Purpose | SV | |
| SVCNTMOD | Contact Mode | Char | (CNTMODE) | Record Qualifier | The way in which the visit was conducted. Examples: "IN PERSON", "TELEPHONE CALL", "IVRS". | Perm | SV | CNTMOD | 9 | SDTM Special-Purpose | SV |
| SVEPCHGI | Epi/Pandemic Related Change Indicator | Char | (NY) | Record Qualifier | Indicates whether the visit was changed due to an epidemic or pandemic. | Perm | SV | EPCHGI | 10 | SDTM Special-Purpose | SV |
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of VISIT. Should be an integer. | Perm | SV | VISITDY | 11 | SDTM Special-Purpose | ||
| SVSTDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Start date/time of an observation represented in IS0 8601 character format. | Exp | SV | STDTC | 12 | SDTM Special-Purpose | SV |
| SVENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | End date/time of the observation represented in IS0 8601 character format. | Exp | SV | ENDTC | 13 | SDTM Special-Purpose | SV |
| SVSTDY | Study Day of Start of Observation | Num | Timing | Actual study day of start of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm | SV | STDY | 14 | SDTM Special-Purpose | SV | |
| SVENDY | Study Day of End of Observation | Num | Timing | Actual study day of end of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm | SV | ENDY | 15 | SDTM Special-Purpose | SV | |
| SVUPDES | Description of Unplanned Visit | Char | Record Qualifier | Description of what happened to the subject during an unplanned visit. Only populated for unplanned visits. | Perm | SV | UPDES | 16 | SDTM Special-Purpose | SV | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DI | STUDYID | 1 | SDTM Study Reference | ||
| DOMAIN | Domain Abbreviation | Char | DI | Identifier | Two-character abbreviation for the domain. | Req | DI | DOMAIN | 2 | SDTM Study Reference | |
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for the device. \n It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers). | Req | DI | SPDEVID | 3 | SDTM Study Reference | ||
| DISEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID) within dataset. \n If there is only one value for DIPARMCD for each value of SPDEVID, then DISEQ will be 1 for all records. DISEQ must be a valid number. | Exp | DI | SEQ | 4 | SDTM Study Reference | DI | |
| DIPARMCD | Device Identifier Element Short Name | Char | Topic | Short name of the identifier characteristic of the device (e.g., "SERIAL", "MODEL"). \n A record with DIPARMCD = "DEVTYPE" should be included (see below). | Req | DI | PARMCD | 5 | SDTM Study Reference | DI | |
| DIPARM | Device Identifier Element Name | Char | Synonym Qualifier | Name of the identifier characteristic of the device. \n Examples: Serial Number, Model. A record with DIPARM = "DEVTYPE" should be included (see below). | Req | DI | PARM | 6 | SDTM Study Reference | DI | |
| DIVAL | Device Identifier Element Value | Char | Result Qualifier | Value for the parameter. Value for the parameter. When DIPARMCD=DEVTYPE it should use controlled terminology defined by FDA in their Preferred Term codelist. FDA has stated a preference for the Global Medical Device Nomenclature (GMDN), but as of the date of this publication, the GMDN is not freely available to the public. In its Unique Device Identification rule, FDA indicated that GMDN will not be required unless it is available to the public at no cost. There is a lookup tool on the FDA website to map GMDN codes to FDA PT codes. | Req | DI | VAL | 7 | SDTM Study Reference | DI | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | ES | STUDYID | 1 | SDTM Study Reference | ||
| DOMAIN | Domain Abbreviation | Char | ES | Identifier | Two-character abbreviation for the domain. | Req | ES | DOMAIN | 2 | SDTM Study Reference | |
| STOCONID | Applicant-defined Storage Conditions ID | Char | Identifier | Applicant-defined identifier for representing a set of storage conditions. Can also be used in the PT domain where storage conditions of the product being tested are applicable (e.g., stability studies). STOCONID should be populated with an intuitive name based on a description of the storage conditions. If a published standard set of conditions is used, the value should represent that (e.g., "E-Liquid Standard Long Term Conditions"). If the study applicant creates their own set of storage conditions, or modifies a standard set, the value should reflect that (e.g., "Modified E-Liquid Standard Long Term Conditions"). It must be unique for each unique set of storage conditions as defined by the specific values of ESPARMCD-ESVAL pairs. | Req | ES | STOCONID | 3 | SDTM Study Reference | ||
| ESSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a parameter within the set of storage conditions represent by STOCONID within the dataset. | Req | ES | SEQ | 4 | SDTM Study Reference | ES | |
| ESPARMCD | Storage Conditions Element Short Name | Char | (ESPARMCD) | Topic | Short name of the identifier or descriptor being described. Examples: "TEMP", "HUMID". | Req | ES | PARMCD | 5 | SDTM Study Reference | ES |
| ESPARM | Tobacco Product ID Element Name | Char | (ESPARM) | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "Temperature", "Humidity". | Req | ES | PARM | 6 | SDTM Study Reference | ES |
| ESVAL | Tobacco Product ID Element Value | Char | Result Qualifier | Value for the parameter in ESPARMCD/ESPARM for a condition within a set of conditions identified by STOCONID. | Req | ES | VAL | 7 | SDTM Study Reference | ES | |
| ESVALU | Tobacco Product ID Element Value Unit | Char | (UNIT) | Result Qualifier | Unit for the value in ESVAL. Must be used when value for the parameter has units. | Perm | ES | VALU | 8 | SDTM Study Reference | ES |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req | TO | STUDYID | 1 | SDTM Study Reference | ||
| DOMAIN | Domain Abbreviation | Char | TO | Identifier | Two-character abbreviation for the domain. | Req | TO | DOMAIN | 2 | SDTM Study Reference | |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. It must be unique for each unique tobacco product as defined by the specific values of the product's TOPARMCD-TOVAL pairs. | Req | TO | SPTOBID | 3 | SDTM Study Reference | ||
| TOSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset. | Req | TO | SEQ | 4 | SDTM Study Reference | TO | |
| TOPARMCD | Tobacco Product ID Element Short Name | Char | (TOPARMCD) | Topic | Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF". | Req | TO | PARMCD | 5 | SDTM Study Reference | TO |
| TOPARM | Tobacco Product ID Element Name | Char | (TOPARM) | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference". | Req | TO | PARM | 6 | SDTM Study Reference | TO |
| TOCAT | Category of Tobacco Product ID Element | Char | (TOCAT) | Grouping Qualifier | Used to define a category of records based on whether the product is new or a predicate product Examples: "NEW PRODUCT", "PREDICATE PRODUCT", "ORIGINAL PRODUCT", and "COMPARISON PRODUCT". | Req | TO | CAT | 7 | SDTM Study Reference | TO |
| TOSCAT | Subcategory of Tobacco Prod ID Element | Char | Grouping Qualifier | Used to define a sub-category of related records (e.g., PRODUCT IDENTIFIER, PRODUCT DESCRIPTOR). | Perm | TO | SCAT | 8 | SDTM Study Reference | TO | |
| TOVAL | Tobacco Product ID Element Value | Char | Result Qualifier | Value for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID. | Req | TO | VAL | 9 | SDTM Study Reference | TO | |
| TOVALU | Tobacco Product ID Element Value Unit | Char | (UNIT) | Result Qualifier | Unit for the value in TOVAL. Will be blank for unitless identifying descriptors (e.g., "Trade Name"). Must be used where applicable (e.g., "Circumference"). | Perm | TO | VALU | 10 | SDTM Study Reference | TO |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TA | STUDYID | 1 | SDTM Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TA | Identifier | Two-character abbreviation for the domain. | Req | TA | DOMAIN | 2 | SDTM Trial Design | |
| ARMCD | Planned Arm Code | Char | Topic | ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than that for other "short" variables to accommodate the kind of values that are likely to be needed for crossover studies/trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each product and separating hyphens, the length of ARMCD values would be 20. | Req | TA | ARMCD | 3 | SDTM Trial Design | ||
| ARM | Description of Planned Arm | Char | Synonym Qualifier | Name given to an arm or exposure group. | Req | TA | ARM | 4 | SDTM Trial Design | ||
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the order of the element within the arm. | Req | TA | ETORD | 5 | SDTM Trial Design | TA | |
| ETCD | Element Code | Char | Record Qualifier | ETCD (the companion to ELEMENT) 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 ETCD will need to serve as a variable name. | Req | TA | ETCD | 6 | SDTM Trial Design | ||
| ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the element. The same element may occur more than once within an arm. | Perm | TA | ELEMENT | 7 | SDTM Trial Design | ||
| TABRANCH | Branch | Char | Rule | Condition subject met, at a "branch" in the study/trial design at the end of this element, to be included in this arm (e.g., "Randomization to PRODUCT X"). | Exp | TA | BRANCH | 8 | SDTM Trial Design | TA | |
| TATRANS | Transition Rule | Char | Rule | If the study/trial design allows a subject to transition to an element other than the next element in sequence, then the conditions for transitioning to those other elements, and the alternative element sequences, are specified in this rule (e.g., "Responders go to washout"). | Exp | TA | TRANS | 9 | SDTM Trial Design | TA | |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Name of the epoch with which this element of the arm is associated. | Req | TA | EPOCH | 10 | SDTM Trial Design | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TE | STUDYID | 1 | SDTM Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TE | Identifier | Two-character abbreviation for the domain. | Req | TE | DOMAIN | 2 | SDTM Trial Design | |
| ETCD | Element Code | Char | Topic | ETCD (the companion to ELEMENT) 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 ETCD will need to serve as a variable name. | Req | TE | ETCD | 3 | SDTM Trial Design | ||
| ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the element. | Req | TE | ELEMENT | 4 | SDTM Trial Design | ||
| TESTRL | Rule for Start of Element | Char | Rule | Describes condition for beginning element. | Req | TE | STRL | 5 | SDTM Trial Design | TE | |
| TEENRL | Rule for End of Element | Char | Rule | Describes condition for ending element. Either TEENRL or TEDUR must be present for each element. | Perm | TE | ENRL | 6 | SDTM Trial Design | TE | |
| TEDUR | Planned Duration of Element | Char | ISO 8601 duration | Timing | Planned duration of element in ISO 8601 format. Used when the rule for ending the element is applied after a fixed duration. | Perm | TE | DUR | 7 | SDTM Trial Design | TE |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TI | STUDYID | 1 | SDTM Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TI | Identifier | Two-character abbreviation for the domain. | Req | TI | DOMAIN | 2 | SDTM Trial Design | |
| IETESTCD | Incl/Excl Criterion Short Name | Char | Topic | Short name IETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. The prefix "IE" is used to ensure consistency with the IE domain. | Req | TI | IETESTCD | 3 | SDTM Trial Design | ||
| IETEST | Inclusion/Exclusion Criterion | Char | Synonym Qualifier | Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain. | Req | TI | IETEST | 4 | SDTM Trial Design | ||
| IECAT | Inclusion/Exclusion Category | Char | (IECAT) | Grouping Qualifier | Used for categorization of the inclusion or exclusion criteria. | Req | TI | IECAT | 5 | SDTM Trial Design | |
| IESCAT | Inclusion/Exclusion Subcategory | Char | Grouping Qualifier | A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or to categorize as major or minor exceptions. Examples: "MAJOR", "MINOR". | Perm | TI | IESCAT | 6 | SDTM Trial Design | ||
| TIRL | Inclusion/Exclusion Criterion Rule | Char | Rule | Rule that expresses the criterion in computer-executable form. | Perm | TI | RL | 7 | SDTM Trial Design | TI | |
| TIVERS | Protocol Criteria Versions | Char | Record Qualifier | The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only 1 version. | Perm | TI | VERS | 8 | SDTM Trial Design | TI | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TS | STUDYID | 1 | SDTM Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TS | Identifier | Two-character abbreviation for the domain. | Req | TS | DOMAIN | 2 | SDTM Trial Design | |
| TSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a parameter. Allows inclusion of multiple records for the same TSPARMCD. | Req | TS | SEQ | 3 | SDTM Trial Design | TS | |
| TSGRPID | Group ID | Char | Identifier | Used to tie together a group of related records. | Perm | TS | GRPID | 4 | SDTM Trial Design | TS | |
| TSPARMCD | Trial Summary Parameter Short Name | Char | (TSPARMCD) | Topic | TSPARMCD (the companion to TSPARM) 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 TSPARMCD will need to serve as variable names. Examples: "AGEMIN", "AGEMAX". | Req | TS | PARMCD | 5 | SDTM Trial Design | TS |
| TSPARM | Trial Summary Parameter | Char | (TSPARM) | Synonym Qualifier | Term for the trial summary parameter. The value in TSPARM cannot be longer than 40 characters. Examples: "Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects". | Req | TS | PARM | 6 | SDTM Trial Design | TS |
| TSVAL | Parameter Value | Char | Result Qualifier | Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indication". TSVAL can only be null when TSVALNF is populated. Text over 200 characters can be added to additional columns TSVAL1-TSVALn. | Exp | TS | VAL | 7 | SDTM Trial Design | TS | |
| TSVALNF | Parameter Value Null Flavor | Char | ISO 21090 NullFlavor | Result Qualifier | Null flavor for the value of TSPARM, to be populated only if TSVAL is null. | Perm | TS | VALNF | 8 | SDTM Trial Design | TS |
| TSVALCD | Parameter Value Code | Char | Result Qualifier | This is the code of the term in TSVAL. 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 | TS | VALCD | 9 | SDTM Trial Design | TS | |
| TSVCDREF | Name of the Reference Terminology | Char | (DICTNAM) | Result Qualifier | The name of the reference terminology from which TSVALCD is taken. For example; CDISC CT, SNOMED, ISO 8601. | Exp | TS | VCDREF | 10 | SDTM Trial Design | TS |
| TSVCDVER | Version of the Reference Terminology | Char | Result Qualifier | The version number of the reference terminology, if applicable. | Exp | TS | VCDVER | 11 | SDTM Trial Design | TS | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TV | STUDYID | 1 | SDTM Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TV | Identifier | Two-character abbreviation for the domain. | Req | TV | DOMAIN | 2 | SDTM Trial Design | |
| VISITNUM | Visit Number | Num | Topic | 1. An assigned numeric identifier that aligns to the chronological order of an encounter. \n 2. Numeric version of VISIT, used for sorting. | Req | TV | VISITNUM | 3 | SDTM Trial Design | ||
| VISIT | Visit Name | Char | Synonym Qualifier | The label for a protocol-defined encounter.May be used in addition to VISITNUM and/or VISITDY. | Req | TV | VISIT | 4 | SDTM Trial Design | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of VISIT. Due to its sequential nature, used for sorting. | Perm | TV | VISITDY | 5 | SDTM Trial Design | ||
| ARMCD | Planned Arm Code | Char | Record Qualifier | ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each product and separating hyphens, the length of ARMCD values would be 20.If the timing of visits for a trial does not depend on which arm a subject is in, then ARMCD should be null. | Exp | TV | ARMCD | 6 | SDTM Trial Design | ||
| ARM | Description of Planned Arm | Char | Synonym Qualifier | Name given to an arm or product exposure group.If the timing of visits for a trial does not depend on which arm a subject is in, then Arm should be left blank. | Perm | TV | ARM | 7 | SDTM Trial Design | ||
| TVSTRL | Visit Start Rule | Char | Rule | Rule describing when the visit starts, in relation to the sequence of elements. | Req | TV | STRL | 8 | SDTM Trial Design | TV | |
| TVENRL | Visit End Rule | Char | Rule | Rule describing when the visit ends, in relation to the sequence of elements. | Perm | TV | ENRL | 9 | SDTM Trial Design | TV |
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