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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 AbbreviationCharDMIdentifierTwo-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.Req
SUBJIDSubject Identifier for the StudyChar
TopicSubject (i.e., Animal) identifier used within the study.Req
RFSTDTCSubject Reference Start Date/TimeCharISO 8601 datetime or intervalRecord QualifierReference start date/time for the subject in ISO 8601 format. Usually equivalent to date/time when subject was first exposed to study treatment. Study day calculation (the --DY variable) in all domains will be based on this date. The collected date used to populate RFSTDTC must be defined in the data definition file. Req
RFENDTCSubject Reference End Date/TimeCharISO 8601 datetime or intervalRecord QualifierReference end date/time for the subject in ISO 8601 format. Usually equivalent to the date/time when the subject was determined to have left the study. The collected date used to populate RFSTDTC must be defined in the data definition file. Exp
RFXSTDTCDate/Time of First Study ExposureCharISO 8601 datetime or intervalRecord QualifierFirst date/time of exposure to any protocol-specified product exposure, equal to the earliest value of EXSTDTC. Note: Absolute first.Perm
RFXENDTCDate/Time of Last Study ExposureCharISO 8601 datetime or intervalRecord QualifierLast date/time of exposure to any protocol-specified product exposure, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). Note: Absolute last.Perm
SITEIDStudy Site IdentifierChar
Record QualifierUnique identifier for a study site within a submission. Use only if subjects are housed at different sites.Perm
BRTHDTCDate/Time of BirthCharISO 8601 datetime or intervalRecord QualifierDate/Time of birth of the subject, in ISO 8601 format.Perm
AGEAgeNum
Record QualifierMay be derived (RFSTDTC - BRTHDTC), but BRTHDTC may not be available in all cases. Age may also be collected.Perm
AGETXTAge RangeCharnumber-numberRecord QualifierUsed when the age is a range and the exact birthdate is not known. This variable is a character field for the purposes of defining age ranges, e.g., if the information available for the age of the subject is 6-8 and AGEU is WEEKS. Populate only when BRTHDTC or AGE is not specified. The format for AGETXT is "number-number" (e.g., 6-8).Perm
AGEUAge UnitChar(AGEU)Variable QualifierUnits associated with AGE and AGETXT.Exp
SEXSexChar(SEX)Record QualifierThe sex of the subject.Req
SPECIESSpeciesChar(SPECIES)Record QualifierIf this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary).Perm
STRAINStrain/SubstrainChar(STRAIN)Record QualifierUsed to identify the vendor-supplied strain, substrain, or breed designation for the test system under study. It may combine the background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, and CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild type strains. It is extensible to accommodate strains not listed and genetically modified substrains. If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). Country of origin for non-human primates should not go into STRAIN. In general, details related to coat color (e.g., White and Red designations for New Zealand Rabbits) should not go into STRAIN.Perm
SBSTRAINStrain/Substrain DetailsChar
Record QualifierFree-text field that allows the to enter further details qualifiying the SPECIES and/or STRAIN, depending on the level to which these variables were defined. Examples include the description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF).Perm
ARMCDPlanned Arm CodeChar
Record QualifierShort name for ARM (may be up to 20 characters) used for sorting and programming. Should be populated when Arms have been defined in the TA domain.Exp
ARMDescription of Planned ArmChar
Synonym QualifierDescriptive name given to a specific Trial Arm to which the subject was assigned.Perm
SETCDSet CodeChar
Record QualifierShort name of a specific Trial Set to which the subject was assigned, as defined by the applicant. Maximum of 8 characters. This represents the Trial Set for which parameters are being submitted.Req

Metadata Checks Findings

SDTM & Related IG Metadata Check User Macros FAQ
  • Content: For variable RFSTDTC, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ]
  • Content: For variable RFENDTC, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ]

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