| 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 | 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 applicant defined. | Exp |
| BWFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. The value should by Y or null. | Perm |
| BWEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
| BWREASEX | Reason for Exclusion | Char |
| Record Qualifier | The reason the result should be excluded from all calculations. Used only when BWEXCLFL is Y. | Perm |
| BWUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm |
| VISITDY | Planned Study Day of Collection | Num |
| Timing | Planned study day of collection. Should be an integer. | Perm |
| BWDTC | Date/Time Animal Weighed | Char | ISO 8601 | Timing | Date/Time of body weight collection in ISO 8601 format. | Exp |
| BWDY | Study Day Animal Weighed | Num |
| Timing | Study day of body weight collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| BWNOMDY | Nominal Study Day for Tabulations | Num |
| Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp |
| BWNOMLBL | Label for Nominal Study Day | Char |
| Timing | A label for a given value of BWNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm |