- Created by Darcy Wold, last modified by Julie Chason on Sep 20, 2023
You are viewing an old version of this page. View the current version.
Compare with Current View Page History
« Previous Version 8 Next »
TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
| DOMAIN | Domain Abbreviation | Char | EX | Identifier | Two-character abbreviation for the domain. | Req |
| 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 | |
| EXSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
| EXGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | |
| EXREFID | Reference ID | Char | Identifier | Internal or external identifier. | Perm | |
| 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 | |
| EXLNKID | Link ID | Char | Identifier | Identifier used to link related records across domains. | Perm | |
| EXLNKGRP | Link Group ID | Char | Identifier | Identifier used to link related, grouped records across domains. | Perm | |
| EXTRT | Name of Product | Char | Topic | Name of the protocol-specified study product given during the dosing period for the observation. | Req | |
| EXCAT | Category of Product | Char | Grouping Qualifier | Used to define a category of EXTRT values. | Perm | |
| EXSCAT | Subcategory of Product | Char | Grouping Qualifier | A further categorization of EXCAT values. | Perm | |
| EXDOSE | Dose | Num | Record Qualifier | Amount of EXTRT when numeric. Not populated when EXDOSTXT is populated. | Exp | |
| 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 | |
| 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 |
| EXDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for EXTRT. | Exp |
| 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 |
| 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 | |
| EXROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for the intervention. Examples: "ORAL". | Perm |
| EXLOT | Lot Number | Char | Record Qualifier | Lot number of the intervention product. | Perm | |
| EXLOC | Location of Dose Administration | Char | (LOC) | Record Qualifier | Specifies location of administration. Examples: "ARM", "LIP". | Perm |
| EXLAT | Laterality | Char | (LAT) | Variable Qualifier | Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT". | Perm |
| EXDIR | Directionality | Char | (DIR) | Variable Qualifier | Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER". | Perm |
| EXFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. Examples: "Y", "N". | Perm |
| EXADJ | Reason for Dose Adjustment | Char | Record Qualifier | Describes reason or explanation of why a dose is adjusted. | Perm | |
| TAETORD | Planned Order of Element within Arm | Num | Timing | Number that gives the planned order of the Element within the Arm. | Perm | |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Trial Epoch of the Exposure record. Examples: "RUN-IN", "FOLLOW-UP". | Perm |
| 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 |
| 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 |
| EXSTDY | Study Day of Start of Exposure | Num | Timing | Study day of EXSTDTC relative to DM.RFSTDTC. | Perm | |
| EXENDY | Study Day of End of Exposure | Num | Timing | Study day of EXENDTC relative to DM.RFSTDTC. | Perm | |
| 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 |
| EXTPT | Planned Time Point Name | Char | Timing |
| Perm | |
| EXTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EXTPT to aid in sorting. | Perm | |
| 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 |
| EXTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EXELTM, EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE. | Perm | |
| 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 |
- No labels
Overview
Content Tools