| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | FA | Identifier | Two-character abbreviation for the domain. | Req |
| 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 |
| FASEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| FAGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm |
| FASPID | Applicant-Defined Identifier | Char |
| Identifier | Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF. | Perm |
| FATESTCD | Findings About Test Short Name | Char | (FATESTCD)
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STATUS
| 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. Example: "OCCUR". Note that controlled terminology is in a FATESTCD general codelist and in several therapeutic area-specific codelists. | Req |
| FATEST | Findings About Test Name | Char | (FATEST) | 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. Example:"Occurrence". Note that controlled terminology is in a FATEST general codelist and in several therapeutic area-specific codelists. | Req |
| 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 (e.g., "Acne") describing a clinical sign or symptom that is being measured by a severity test; an event (e.g., "VOMIT, where the volume of vomit is being measured by a VOLUME test). | Req |
| FACAT | Category for Findings About | Char |
| Grouping Qualifier | Used to define a category of related records. Examples: "GERD", "PRE-SPECIFIED AE". | Perm |
| FASCAT | Subcategory for Findings About | Char |
| Grouping Qualifier | A further categorization of FACAT. | Perm |
| FAORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the test as originally received or collected. | Exp |
| FAORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for FAORRES. | Perm |
| 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 |
| 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 |
| FASTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for FASTRESC and FASTRESN. | Perm |
| 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 |
| 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 |
| FALOC | Location of the Finding About | Char | (LOC) | Record Qualifier | Used to specify the location of the clinical evaluation. Example: "ARM". | Perm |
| FALAT | Laterality | Char | (LAT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL". | Perm |
| 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 |
| 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 |
| VISITNUM | Visit Number | Num |
| Timing | - An assigned numeric identifier that aligns to the chronological order of an encounter.
- Numeric version of VISIT, used for sorting.
| Exp |
| VISIT | Visit Name | Char |
| Timing | - The label for a protocol-defined encounter.
- May be used in addition to VISITNUM and/or VISITDY.
| Perm |
| VISITDY | Planned Study Day of Visit | Num |
| Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm |
| TAETORD | Planned Order of Element within Arm | Num |
| Timing | Number that gives the planned order of the element within the arm. | Perm |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the date/time of the observation. Examples: "SCREENING", "PRODUCT EXPOSURE", "FOLLOW-UP". | Perm |
| FADTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of findings assessment represented in ISO 8601 character format. | Exp |
| FADY | Study Day of Collection | Num |
| Timing | - Study day of collection, measured as integer days.
- Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
| Perm |