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

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharFWIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated.Exp
POOLIDPool IdentifierChar
IdentifierIdentifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated.Perm
FWSEQSequence NumberNum
IdentifierThe sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.Req
FWGRPIDGroup IdentifierChar
IdentifierUsed to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.Perm
FWTESTCDFood/Water Consumption Short NameChar(FWTESTCD)TopicShort name of the measurement, test, or examination described in FWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FWTESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled values are FC, FCRELBW, WC, and WCRELBW.Req
FWTESTFood/Water Consumption NameChar(FWTEST)Synonym QualifierLong name for FWTESTCD. The value in FWTEST cannot be longer than 40 characters. Extensible controlled values are Food Consumption, Food Consumption Relative to Body Wt, Water Consumption, Water Consumption Relative to Body Wt.Req
FWORRESResult or Findings as CollectedChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
FWORRESUUnit of the Original ResultChar(UNIT)Variable QualifierThe unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list.Exp
FWSTRESCStandardized Result in Character FormatChar
Result QualifierContains the result value for all findings, copied or derived from FWORRES, in a standard format or standard units. FWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in FWSTRESN.Exp
FWSTRESNStandardized Result in Numeric FormatNum
Result QualifierUsed for numeric results or findings in standard format; contains the numeric form of FWSTRESC. FWSTRESN should store all numeric test results or findings.Exp
FWSTRESUUnit of the Standardized ResultChar(UNIT)Variable QualifierStandardized unit used for FWSTRESC and FWSTRESN.Exp
FWSTATCompletion StatusChar(ND)Record QualifierUsed to indicate when a test is not done or result is missing. Should be null if a result exists in FWORRES.Perm
FWREASNDReason Not DoneChar
Record QualifierDescribes why FWSTAT is NOT DONE, such as FOOD WET.Perm
FWEXCLFLExclusion FlagChar(NY)Record QualifierY if the result should be excluded from all calculations, otherwise null.Perm
FWREASEXReason for ExclusionChar
Record QualifierThe reason the result should be excluded from all calculations. Used only when FWEXCLFL is Y.Perm
FWDTCStart Date/Time of ObservationCharISO 8601TimingDate/Time of the start of the observation in IS0 8601 format.Exp
FWENDTCEnd Date/Time of ObservationCharISO 8601TimingDate/Time of the end of the observation in IS0 8601 format.Exp
FWDYStudy Day of Start of ObservationNum
TimingStudy day of the start of the observation, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.Perm
FWENDYStudy Day of End of ObservationNum
TimingStudy day of the end of the observation, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.Perm

Metadata Checks Findings

SDTM & Related IG Metadata Check User Macros FAQ
  • Content: For variable FWDTC, ISO 8601 is a not a recognized content for Controlled Terms, Codelist, or Format
  • Content: For variable FWENDTC, ISO 8601 is a not a recognized content for Controlled Terms, Codelist, or Format

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