Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 DA 1 STUDYID Study Identifier Char Identifier Unique identifier for a study within the submission. Req
SDTMIG 3.3 DA 2 DOMAIN Domain Abbreviation Char DA Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 DA 3 USUBJID Unique Subject Identifier Char Identifier Unique subject identifier within the submission. Req
SDTMIG 3.3 DA 4 DASEQ 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 DA 5 DAGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 DA 6 DAREFID Reference ID Char Identifier Internal or external identifier such as label number. Perm
SDTMIG 3.3 DA 7 DASPID 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. Examples: Line number on the Drug Accountability page, drug label code. Perm
SDTMIG 3.3 DA 8 DATESTCD Short Name of Accountability Assessment Char (DATESTCD) Topic Short character value for DATEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters and cannot begin with a number or contain characters other than letters, numbers, or underscores. Example: "DISPAMT", "RETAMT". Req
SDTMIG 3.3 DA 9 DATEST Name of Accountability Assessment Char (DATEST) Synonym Qualifier Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the drug accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: "Dispensed Amount", "Returned Amount". Req
SDTMIG 3.3 DA 10 DACAT Category Char Grouping Qualifier Used to define a category of topic-variable values. Examples: "STUDY MEDICATION", "RESCUE MEDICATION". Perm
SDTMIG 3.3 DA 11 DASCAT Subcategory Char Grouping Qualifier Used to define a further categorization level for a group of related records. Perm
SDTMIG 3.3 DA 12 DAORRES Result or Finding in Original Units Char Result Qualifier Result of the Drug Accountability assessment as originally received or collected. Exp
SDTMIG 3.3 DA 13 DAORRESU Original Units Char (UNIT) Variable Qualifier Unit for DAORRES. Perm
SDTMIG 3.3 DA 14 DASTRESC Result or Finding in Standard Format Char Result Qualifier Contains the result value for all Drug Accountability assessments, copied or derived from DAORRES in a standard format or in standard units. DASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DASTRESN. Exp
SDTMIG 3.3 DA 15 DASTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Used for continuous or numeric results or findings in standard format; copied in numeric format from DASTRESC. DASTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 DA 16 DASTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for DASTRESC and DASTRESN. Perm
SDTMIG 3.3 DA 17 DASTAT Completion Status Char (ND) Record Qualifier Used to indicate that a drug accountability assessment was not done. Should be null or have a value of "NOT DONE". Perm
SDTMIG 3.3 DA 18 DAREASND Reason Not Done Char Record Qualifier Reason not done. Used in conjunction with DASTAT when value is "NOT DONE". Perm
SDTMIG 3.3 DA 19 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 DA 20 VISIT Visit Name Char Timing 1. Protocol-defined description of a clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 DA 21 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit, based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 DA 22 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 DA 23 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. Perm
SDTMIG 3.3 DA 24 DADTC Date/Time of Collection Char ISO 8601 Timing Date and time of the drug accountability assessment represented in ISO 8601 character format. Exp
SDTMIG 3.3 DA 25 DADY Study Day of Visit/Collection/Exam Num Timing 1. Study day of drug accountability assessment, measured in integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC in Demographics. Perm