| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | 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 (e.g., kit number, bottle label, vial identifier). | Perm |
| EXSPID | SponsorApplicant-Defined Identifier | Char |
| Identifier | SponsorApplicant-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsorapplicant'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 TreatmentProduct | Char* |
| Topic | Name of the protocol-specified study treatment product given during the dosing period for the observation. | Req |
| EXCAT | Category of TreatmentProduct | Char* |
| Grouping Qualifier | Used to define a category of EXTRT values. | Perm |
| EXSCAT | Subcategory of TreatmentProduct | 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. Examples: "TABLET", "LOTION". | 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. Examples: "Q2H", "QD", "BID". | 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", "INTRAVENOUS". | 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 Study Epoch of the Exposure record. Examples: "RUN-IN", "TREATMENTFOLLOW-UP". | Perm |
| EXSTDTC | Start Date/Time of TreatmentExposure | Char | ISO 8601 datetime or interval | Timing | The date/time when administration of the treatment product indicated by EXTRT and EXDOSE began. | Exp |
| EXENDTC | End Date/Time of TreatmentExposure | Char | ISO 8601 datetime or interval | Timing | The date/time when administration of the treatment product indicated by EXTRT and EXDOSE 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, EXSTDTC should be copied to EXENDTC as the standard representation. | Exp |
| EXSTDY | Study Day of Start of TreatmentExposure | Num |
| Timing | Study day of EXSTDTC relative to DM.RFSTDTC. | Perm |
| EXENDY | Study Day of End of TreatmentExposure | Num |
| Timing | Study day of EXENDTC relative to DM.RFSTDTC. | Perm |
| EXDUR | Duration of TreatmentExposure | 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 | - 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 EXTPTNUM and EXTPTREF.
| 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, PREVIOUS MEAL. | 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 |