Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 IE 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 IE 2 DOMAIN Domain Abbreviation Char IE Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 IE 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 IE 4 IESEQ 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 IE 5 IESPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Inclusion or Exclusion criteria number from CRF. Perm
SDTMIG 3.3 IE 6 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
SDTMIG 3.3 IE 7 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
SDTMIG 3.3 IE 8 IECAT Inclusion/Exclusion Category Char (IECAT) Grouping Qualifier Used to define a category of related records across subjects. Req
SDTMIG 3.3 IE 9 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
SDTMIG 3.3 IE 10 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
SDTMIG 3.3 IE 11 IESTRESC I/E Criterion Result in Std Format Char (NY) Result Qualifier Response to Inclusion/Exclusion criterion result in standard format. Req
SDTMIG 3.3 IE 12 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Perm
SDTMIG 3.3 IE 13 VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 IE 14 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 IE 15 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
SDTMIG 3.3 IE 16 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the observation date/time of the inclusion/exclusion finding. Perm
SDTMIG 3.3 IE 17 IEDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of the inclusion/exclusion criterion represented in ISO 8601 character format. Perm
SDTMIG 3.3 IE 18 IEDY Study Day of Collection Num Timing 1. Study day of collection of the inclusion/exclusion exceptions, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. Perm