SDTM.FA

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	FA	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	FA	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	FA	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	FA	FASEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	FA	FAGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	FA	FASPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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.
7	FA	FATESTCD	Findings About Test Short Name	Char		Topic	Req	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.
8	FA	FATEST	Findings About Test Name	Char		Synonym Qualifier	Req	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.
9	FA	FAOBJ	Object of the Observation	Char		Record Qualifier	Req	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.
10	FA	FACAT	Category for Findings About	Char		Grouping Qualifier	Perm	Used to define a category of related records. Examples: "GERD", "PRE-SPECIFIED AE".
11	FA	FASCAT	Subcategory for Findings About	Char		Grouping Qualifier	Perm	A further categorization of FACAT.
12	FA	FAORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the test as originally received or collected.
13	FA	FAORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Original units in which the data were collected. The unit for FAORRES.
14	FA	FASTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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".
15	FA	FASTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Perm	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.
16	FA	FASTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized unit used for FASTRESC and FASTRESN.
17	FA	FASTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that the measurement was not done. Should be null if a result exists in FAORRES.
18	FA	FAREASND	Reason Not Performed	Char		Record Qualifier	Perm	Describes why a question was not answered. Example: "Subject refused". Used in conjunction with FASTAT when value is "NOT DONE".
19	FA	FALOC	Location of the Finding About	Char	C74456	Record Qualifier	Perm	Used to specify the location of the clinical evaluation. Example: "ARM".
20	FA	FALAT	Laterality	Char	C99073	Variable Qualifier	Perm	Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".
21	FA	FALOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
22	FA	FABLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	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.
23	FA	FAEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	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".
24	FA	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
25	FA	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
26	FA	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
27	FA	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm.
28	FA	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the date/time of the observation. Examples: "SCREENING", "TREATMENT", "FOLLOW-UP".
29	FA	FADTC	Date/Time of Collection	Char	ISO 8601	Timing	Perm	Collection date and time of findings assessment represented in ISO 8601 character format.
30	FA	FADY	Study Day of Collection	Num		Timing	Perm	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.