Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 SS 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 SS 2 DOMAIN Domain Abbreviation Char SS Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 SS 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 SS 4 SSSEQ 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 SS 5 SSGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 SS 6 SSSPID 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: Line number from the procedure or test page. Perm
SDTMIG 3.3 SS 7 SSTESTCD Status Short Name Char (SSTESTCD) Topic Short name of the status assessment described in SSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SSTESTCD cannot contain characters other than letters, numbers, or underscores. Example: "SURVSTAT". Req
SDTMIG 3.3 SS 8 SSTEST Status Name Char (SSTEST) Synonym Qualifier Verbatim name of the status assessment used to obtain the finding. The value in SSTEST cannot be longer than 40 characters. Example: "Survival Status". Req
SDTMIG 3.3 SS 9 SSCAT Category for Assessment Char Grouping Qualifier Used to categorize observations across subjects. Perm
SDTMIG 3.3 SS 10 SSSCAT Subcategory for Assessment Char Grouping Qualifier A further categorization. Perm
SDTMIG 3.3 SS 11 SSORRES Result or Finding Original Result Char Result Qualifier Result of the status assessment finding as originally received or collected. Exp
SDTMIG 3.3 SS 12 SSSTRESC Character Result/Finding in Std Format Char (SSTATRS) Result Qualifier Contains the result value for all findings, copied or derived from SSORRES in a standard format. Exp
SDTMIG 3.3 SS 13 SSSTAT Completion Status Char (ND) Record Qualifier Used to indicate a status assessment was not done. Should be null if a result exists in SSORRES. Perm
SDTMIG 3.3 SS 14 SSREASND Reason Assessment Not Performed Char Record Qualifier Describes why an assessment was not performed. Example: "Subject Refused". Used in conjunction with SSSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 SS 15 SSEVAL Evaluator Char (EVAL) Record Qualifier Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "CAREGIVER", "ADJUDICATION COMMITTEE", "FRIEND". Perm
SDTMIG 3.3 SS 16 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 SS 17 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 SS 18 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 SS 19 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 SS 20 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the subject status assessment. Perm
SDTMIG 3.3 SS 21 SSDTC Date/Time of Assessment Char ISO 8601 Timing Date and time of the subject status assessment represented in ISO 8601 character format. Exp
SDTMIG 3.3 SS 22 SSDY Study Day of Assessment Num Timing 1. Study day of the test, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Perm