Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 FA 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 FA 2 DOMAIN Domain Abbreviation Char FA Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 FA 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 FA 4 FASEQ 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 FA 5 FAGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 FA 6 FASPID 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 on a CRF. Perm
SDTMIG 3.3 FA 7 FATESTCD Findings About Test Short Name Char Topic Short name of the measurement, test, or examination described in FATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FATESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SEV", "OCCUR". Note that controlled terminology is in several therapeutic area-specific codelists. Req
SDTMIG 3.3 FA 8 FATEST Findings About Test Name Char Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or finding. The value in FATEST cannot be longer than 40 characters. Examples: "Severity/Intensity", "Occurrence". Note that controlled terminology is in several therapeutic area-specific codelists. Req
SDTMIG 3.3 FA 9 FAOBJ Object of the Observation Char Record Qualifier Used to describe the object or focal point of the findings observation that is represented by --TEST. Examples: the term (such as Acne) describing a clinical sign or symptom that is being measured by a Severity test, or an event such as VOMIT, where the volume of Vomit is being measured by a VOLUME test. Req
SDTMIG 3.3 FA 10 FACAT Category for Findings About Char Grouping Qualifier Used to define a category of related records. Examples: "GERD", "PRE-SPECIFIED AE". Perm
SDTMIG 3.3 FA 11 FASCAT Subcategory for Findings About Char Grouping Qualifier A further categorization of FACAT. Perm
SDTMIG 3.3 FA 12 FAORRES Result or Finding in Original Units Char Result Qualifier Result of the test as originally received or collected. Exp
SDTMIG 3.3 FA 13 FAORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. The unit for FAORRES. Perm
SDTMIG 3.3 FA 14 FASTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the result value for all findings, copied or derived from FAORRES in a standard format or standard units. FASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in FASTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in FAORRES, and these results effectively have the same meaning; they could be represented in standard format in FASTRESC as "NEGATIVE". Exp
SDTMIG 3.3 FA 15 FASTRESN 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 FASTRESC. FASTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 FA 16 FASTRESU Standard Units Char (UNIT) Variable Qualifier Standardized unit used for FASTRESC and FASTRESN. Perm
SDTMIG 3.3 FA 17 FASTAT Completion Status Char (ND) Record Qualifier Used to indicate that the measurement was not done. Should be null if a result exists in FAORRES. Perm
SDTMIG 3.3 FA 18 FAREASND Reason Not Performed Char Record Qualifier Describes why a question was not answered. Example: "Subject refused". Used in conjunction with FASTAT when value is "NOT DONE". Perm
SDTMIG 3.3 FA 19 FALOC Location of the Finding About Char (LOC) Record Qualifier Used to specify the location of the clinical evaluation. Example: "ARM". Perm
SDTMIG 3.3 FA 20 FALAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 FA 21 FALOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. Perm
SDTMIG 3.3 FA 22 FABLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. The value should be "Y" or null. Note that FABLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 FA 23 FAEVAL 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: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR". Perm
SDTMIG 3.3 FA 24 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 FA 25 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 FA 26 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 FA 27 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 FA 28 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time of the observation. Examples: "SCREENING", "TREATMENT", "FOLLOW-UP". Perm
SDTMIG 3.3 FA 29 FADTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of findings assessment represented in ISO 8601 character format. Perm
SDTMIG 3.3 FA 30 FADY Study Day of Collection Num Timing 1. Study day of collection, 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