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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 AbbreviationCharCOIdentifierTwo-character abbreviation for the domain.Req
RDOMAINRelated Domain AbbreviationChar(DOMAIN)Record QualifierTwo-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page.Perm
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
COSEQSequence NumberNum
IdentifierSequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
IDVARIdentifying VariableChar*Record QualifierIdentifying variable in the parent dataset that identifies the record(s) to which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments are related to domain records. Null for comments collected on separate CRFs.Perm
IDVARVALIdentifying Variable ValueChar
Record QualifierValue of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs.Perm
COREFComment ReferenceChar
Record QualifierApplicant-defined reference associated with the comment. May be the CRF page number (e.g., 650), or a module name (e.g., DEMOG), or a combination of information that identifies the reference (e.g. 650-VITALS-VISIT 2).Perm
COVALCommentChar
TopicThe text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.Req
COEVALEvaluatorChar(EVAL)Record QualifierRole of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Example: "INVESTIGATOR".Perm
COEVALIDEvaluator IdentifierChar(MEDEVAL)Record QualifierUsed to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: "RADIOLOGIST", "RADIOLOGIST 1", "RADIOLOGIST 2".Perm
CODTCDate/Time of CommentCharISO 8601 datetime or intervalTimingDate/time of comment on dedicated comment form. Should be null if this is a child record of another domain or if comment date was not collected.Perm
CODYStudy Day of CommentNum
TimingStudy day of the comment, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.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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