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 a study 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 Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment dosing group number. | Perm |
SCTESTCD | Subject Characteristic Short Name | Char | (SBCCDSND) | 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. Some extensible controlled values are: SPLRNAM, SPLRLOC, HAIRCOLR. | Req |
SCTEST | Subject Characteristic | Char | (SBCSND) | Synonym Qualifier | Long name for SCTESTCD. The value in SCTEST cannot be longer than 40 characters. Examples: Test Subject Supplier, Test Subject Supplier Site, and Hair Coat Color. | Req |
SCORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the subject characteristic as originally received or collected. | Exp |
SCORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Perm |
SCSTRESC | Standardized Result in Character 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, these results effectively have the same meaning. In this case, they could be represented in standard format in SCSTRESC with a single term NEGATIVE. | Exp |
SCSTRESN | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of SCSTRESC. SCSTRESN should store all numeric test results or findings. | Perm |
SCSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for SCSTRESC and SCSTRESN. | Perm |
SCDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of collection of the subject characteristic information, in ISO 8601 format. | Perm |
SCDY | Study Day of Collection | Num |
| Timing | Study day of collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |