Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
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STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | BW | 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 |
BWSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
BWTESTCD | Test Short Name | Char | (BWTESTCD) | Topic | Short name of the measurement, test, or examination described in BWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in BWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). BWTESTCD cannot contain characters other than letters, numbers, or underscores. | Req |
BWTEST | Test Name | Char | (BWTEST) | Synonym Qualifier | Long name for BWTESTCD. The value in BWTEST cannot be longer than 40 characters. | Req |
BWORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp |
BWORRESU | 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. | Exp |
BWSTRESC | Standardized Result in Character Format | Char |
| Result Qualifier | Contains the result value for all findings, copied or derived from BWORRES in a standard format or standard units. BWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in BWSTRESN. | Exp |
BWSTRESN | Standardized Result in Numeric Format | Num |
| Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of BWSTRESC. BWSTRESN should store all numeric test results or findings. | Exp |
BWSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for BWSTRESC and BWSTRESN. | Exp |
BWSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in BWORRES. | Perm |
BWREASND | Reason Not Done | Char |
| Record Qualifier | Describes why BWSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT. | Perm |
BWBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is |