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SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1

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 AbbreviationCharDVIdentifierTwo-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
DVSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DVREFIDReference IDChar
IdentifierInternal or external identifier.Perm
DVSPIDSponsor-Defined IdentifierChar
IdentifierSponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF page.Perm
DVTERMProtocol Deviation TermChar
TopicVerbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". DVTERM values will map to the controlled terminology in DVDECOD (e.g., "STUDY PRODUCT ASSIGNMENT DEVIATION").Req
DVDECODProtocol Deviation Coded TermChar
Synonym QualifierControlled terminology for the name of the protocol deviation. Examples: "STUDY PRODUCT ASSIGNMENT DEVIATION", "EXCLUDED CONCOMITANT MEDICATION".Perm
DVCATCategory for Protocol DeviationChar
Grouping QualifierCategory of the protocol deviation criterion.Perm
DVSCATSubcategory for Protocol DeviationChar
Grouping QualifierA further categorization of the protocol deviation.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the element within the arm.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the deviation. Examples: "PRODUCT EXPOSURE", "SCREENING", "FOLLOW-UP".Perm
DVSTDTCStart Date/Time of DeviationCharISO 8601 datetime or intervalTimingStart date/time of deviation represented in ISO 8601 character format.Perm
DVENDTCEnd Date/Time of DeviationCharISO 8601 datetime or intervalTimingEnd date/time of deviation represented in ISO 8601 character format.Perm
DVSTDYStudy Day of Start of Deviation EventNum
TimingStudy day of start of event relative to the applicant-defined RFSTDTC.Perm
DVENDYStudy Day of End of Deviation EventNum
TimingStudy day of end of event relative to the applicant-defined RFSTDTC.Perm

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format (seen) vs. Controlled Terms, Codelist or Format1 (expected)
  • Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>
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