| 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 | SC | 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 |
| SCSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| SCGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm |
| SCSPID | 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. | Perm |
| SCTESTCD | Subject Characteristic Short Name | Char | (SCTESTCD) | Topic | Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "MARISTAT", "NATORIG". | Req |
| SCTEST | Subject Characteristic | Char | (SCTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in SCTEST cannot be longer than 40 characters. Examples: "Marital Status", "National Origin". | Req |
| SCCAT | Category for Subject Characteristic | Char |
| Grouping Qualifier | Used to define a category of related records. | Perm |
| SCSCAT | Subcategory for Subject Characteristic | Char |
| Grouping Qualifier | A further categorization of the subject characteristic. | Perm |
| SCORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the subject characteristic as originally received or collected. | Exp |
| SCORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original unit in which the data were collected. The unit for SCORRES. | Perm |
| SCSTRESC | Character Result/Finding in Std Format | Char |
| Result Qualifier | Contains the result value for all findings copied or derived from SCORRES, in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in SCORRES, and these results effectively have the same meaning, they could be represented in standard format in SCSTRESC as "NEGATIVE". | Exp |
| SCSTRESN | 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 SCSTRESC. SCSTRESN should store all numeric test results or findings. | Perm |
| SCSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for SCSTRESC or SCSTRESN. | Perm |
| SCSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that the measurement was not done. Should be null if a result exists in SCORRES. | Perm |
| SCREASND | Reason Not Performed | Char |
| Record Qualifier | Describes why the observation has no result. Example: "Subject refused". Used in conjunction with SCSTAT when value is "NOT DONE". | 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.
| Perm |
| 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 start date/time at which the assessment was made. | Perm |
| SCDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of the subject characteristic represented in ISO 8601 character format. | Perm |
| SCDY | Study Day of Examination | Num |
| Timing | Study day of collection, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm |