SEND Body Weights (BW)

Description

This domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights).

bw.xpt, Body Weights — Findings. One record per test per observation time per subject, Tabulation.

Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

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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 datetime or interval	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 applicant-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

Assumptions

Definition: The Body Weight (BW) domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights).

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