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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2
Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| 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 | 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 |
| Exp | |
| VISIT | Visit Name | Char | Timing |
| 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 |
| Perm |
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