Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 EX 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 EX 2 DOMAIN Domain Abbreviation Char EX Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 EX 3 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
SDTMIG 3.3 EX 4 EXSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 EX 5 EXGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 EX 6 EXREFID Reference ID Char Identifier Internal or external identifier (e.g., kit number, bottle label, vial identifier). Perm
SDTMIG 3.3 EX 7 EXSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF Page. Perm
SDTMIG 3.3 EX 8 EXLNKID Link ID Char Identifier Identifier used to link related records across domains. Perm
SDTMIG 3.3 EX 9 EXLNKGRP Link Group ID Char Identifier Identifier used to link related, grouped records across domains. Perm
SDTMIG 3.3 EX 10 EXTRT Name of Treatment Char Topic Name of the protocol-specified study treatment given during the dosing period for the observation. Req
SDTMIG 3.3 EX 11 EXCAT Category of Treatment Char Grouping Qualifier Used to define a category of EXTRT values. Perm
SDTMIG 3.3 EX 12 EXSCAT Subcategory of Treatment Char Grouping Qualifier A further categorization of EXCAT values. Perm
SDTMIG 3.3 EX 13 EXDOSE Dose Num Record Qualifier Amount of EXTRT when numeric. Not populated when EXDOSTXT is populated. Exp
SDTMIG 3.3 EX 14 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
SDTMIG 3.3 EX 15 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
SDTMIG 3.3 EX 16 EXDOSFRM Dose Form Char (FRM) Variable Qualifier Dose form for EXTRT. Examples: "TABLET", "LOTION". Exp
SDTMIG 3.3 EX 17 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
SDTMIG 3.3 EX 18 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
SDTMIG 3.3 EX 19 EXROUTE Route of Administration Char (ROUTE) Variable Qualifier Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS". Perm
SDTMIG 3.3 EX 20 EXLOT Lot Number Char Record Qualifier Lot number of the intervention product. Perm
SDTMIG 3.3 EX 21 EXLOC Location of Dose Administration Char (LOC) Record Qualifier Specifies location of administration. Examples: "ARM", "LIP". Perm
SDTMIG 3.3 EX 22 EXLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT". Perm
SDTMIG 3.3 EX 23 EXDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER". Perm
SDTMIG 3.3 EX 24 EXFAST Fasting Status Char (NY) Record Qualifier Indicator used to identify fasting status. Examples: "Y", "N". Perm
SDTMIG 3.3 EX 25 EXADJ Reason for Dose Adjustment Char Record Qualifier Describes reason or explanation of why a dose is adjusted. Perm
SDTMIG 3.3 EX 26 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm. Perm
SDTMIG 3.3 EX 27 EPOCH Epoch Char (EPOCH) Timing Trial Epoch of the Exposure record. Examples: "RUN-IN", "TREATMENT". Perm
SDTMIG 3.3 EX 28 EXSTDTC Start Date/Time of Treatment Char ISO 8601 Timing The date/time when administration of the treatment indicated by EXTRT and EXDOSE began. Exp
SDTMIG 3.3 EX 29 EXENDTC End Date/Time of Treatment Char ISO 8601 Timing The date/time when administration of the treatment 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
SDTMIG 3.3 EX 30 EXSTDY Study Day of Start of Treatment Num Timing Study day of EXSTDTC relative to DM.RFSTDTC. Perm
SDTMIG 3.3 EX 31 EXENDY Study Day of End of Treatment Num Timing Study day of EXENDTC relative to DM.RFSTDTC. Perm
SDTMIG 3.3 EX 32 EXDUR Duration of Treatment Char ISO 8601 Timing Collected duration of administration. Used only if collected on the CRF and not derived from start and end date/times. Perm
SDTMIG 3.3 EX 33 EXTPT Planned Time Point Name Char Timing 1. Text Description of time when administration should occur. 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
SDTMIG 3.3 EX 34 EXTPTNUM Planned Time Point Number Num Timing Numerical version of EXTPT to aid in sorting. Perm
SDTMIG 3.3 EX 35 EXELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 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
SDTMIG 3.3 EX 36 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
SDTMIG 3.3 EX 37 EXRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by EXTPTREF. Perm