Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 PR 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 PR 2 DOMAIN Domain Abbreviation Char PR Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 PR 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 PR 4 PRSEQ Sequence Number Num Identifier Sequence Number to ensure uniqueness of records within a dataset for a subject. Should be assigned to be in a consistent chronological order. Req
SDTMIG 3.3 PR 5 PRGRPID Group ID Char Identifier Used to link together a block of related records within a subject in a domain. Perm
SDTMIG 3.3 PR 6 PRSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Example: pre-printed line identifier on a CRF or record identifier defined in the sponsor's operational database. Perm
SDTMIG 3.3 PR 7 PRLNKID Link ID Char Identifier Used to facilitate identification of relationships between records. Perm
SDTMIG 3.3 PR 8 PRLNKGRP Link Group ID Char Identifier Used to facilitate identification of relationships between records. Perm
SDTMIG 3.3 PR 9 PRTRT Reported Name of Procedure Char Topic Name of procedure performed, either pre-printed or collected on a CRF. Req
SDTMIG 3.3 PR 10 PRDECOD Standardized Procedure Name Char Synonym Qualifier Standardized or dictionary-derived name of PRTRT. The sponsor is expected to provide the dictionary name and version used to map the terms in the external codelist element in the Define-XML document. If an intervention term does not have a decode value in the dictionary, then PRDECOD will be null. Perm
SDTMIG 3.3 PR 11 PRCAT Category Char Grouping Qualifier Used to define a category of procedure values. Perm
SDTMIG 3.3 PR 12 PRSCAT Subcategory Char Grouping Qualifier Used to define a further categorization of PRCAT values. Perm
SDTMIG 3.3 PR 13 PRPRESP Pre-specified Char (NY) Variable Qualifier Used when a specific procedure is pre-specified on a CRF. Values should be "Y" or null. Perm
SDTMIG 3.3 PR 14 PROCCUR Occurrence Char (NY) Record Qualifier Used to record whether a pre-specified procedure occurred when information about the occurrence of a specific procedure is solicited. Perm
SDTMIG 3.3 PR 15 PRINDC Indication Char Record Qualifier Denotes the indication for the procedure (e.g., why the procedure was performed). Perm
SDTMIG 3.3 PR 16 PRDOSE Dose Num Record Qualifier Amount of PRTRT administered. Not populated when PRDOSTXT is populated. Perm
SDTMIG 3.3 PR 17 PRDOSTXT Dose Description Char Record Qualifier Dosing information collected in text form. Examples: "<1", "200-400". Not populated when PRDOSE is populated. Perm
SDTMIG 3.3 PR 18 PRDOSU Dose Units Char (UNIT) Variable Qualifier Units for PRDOSE, PRDOSTOT, or PRDOSTXT. Perm
SDTMIG 3.3 PR 19 PRDOSFRM Dose Form Char (FRM) Variable Qualifier Dose form for PRTRT. Perm
SDTMIG 3.3 PR 20 PRDOSFRQ Dosing Frequency per Interval Char (FREQ) Variable Qualifier Usually expressed as the number of doses given per a specific interval. Perm
SDTMIG 3.3 PR 21 PRDOSRGM Intended Dose Regimen Char Variable Qualifier Text description of the intended schedule or regimen for the procedure. Perm
SDTMIG 3.3 PR 22 PRROUTE Route of Administration Char (ROUTE) Variable Qualifier Route of administration for PRTRT. Perm
SDTMIG 3.3 PR 23 PRLOC Location of Procedure Char (LOC) Record Qualifier Anatomical location of a procedure. Perm
SDTMIG 3.3 PR 24 PRLAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Perm
SDTMIG 3.3 PR 25 PRDIR Directionality Char (DIR) Variable Qualifier Qualifier for anatomical location or specimen further detailing directionality. Perm
SDTMIG 3.3 PR 26 PRPORTOT Portion or Totality Char (PORTOT) Variable Qualifier Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. Perm
SDTMIG 3.3 PR 27 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Perm
SDTMIG 3.3 PR 28 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 PR 29 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 PR 30 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 PR 31 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the procedure. Perm
SDTMIG 3.3 PR 32 PRSTDTC Start Date/Time of Procedure Char ISO 8601 Timing Start date/time of the procedure represented in ISO 8601 character format. Exp
SDTMIG 3.3 PR 33 PRENDTC End Date/Time of Procedure Char ISO 8601 Timing End date/time of the procedure represented in ISO 8601 character format. Perm
SDTMIG 3.3 PR 34 PRSTDY Study Day of Start of Procedure Num Timing Study day of start of procedure expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 PR 35 PRENDY Study Day of End of Procedure Num Timing Study day of end of procedure expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 PR 36 PRDUR Duration of Procedure Char ISO 8601 Timing Collected duration of a procedure represented in ISO 8601 character format. Used only if collected on the CRF and not derived from start and end date/times. Perm
SDTMIG 3.3 PR 37 PRTPT Planned Time Point Name Char Timing Text description of time when a procedure should be performed. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See PRTPTNUM and PRTPTREF. Perm
SDTMIG 3.3 PR 38 PRTPTNUM Planned Time Point Number Num Timing Numerical version of planned time point used in sorting. Perm
SDTMIG 3.3 PR 39 PRELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time in ISO 8601 format relative to a planned fixed reference (PRTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration. Perm
SDTMIG 3.3 PR 40 PRTPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by PRELTM, PRTPTNUM, and PRTPT. Perm
SDTMIG 3.3 PR 41 PRRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by PRTRTREF in ISO 8601 character format. Perm
SDTMIG 3.3 PR 42 PRSTRTPT Start Relative to Reference Time Point Char (STENRF) Timing Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable PRSTTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 PR 43 PRSTTPT Start Reference Time Point Char Timing Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by PRSTRTPT. Examples: "2003-12-15" or "VISIT 1". Perm
SDTMIG 3.3 PR 44 PRENRTPT End Relative to Reference Time Point Char (STENRF) Timing Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable PRENTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 PR 45 PRENTPT End Reference Time Point Char Timing Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by PRENRTPT. Examples: "2003-12-25" or "VISIT 2". Perm