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
Abbreviation for the domain of the parent record(s).
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.
Exp
IDVAR
Identifying Variable
Char
Identifier
Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID.
Req
IDVARVAL
Identifying Variable Value
Char
Identifier
Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here.
Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. Used only when identifying a relationship between datasets).
Exp
RELID
Relationship Identifier
Char
Record Qualifier
Unique value within USUBJID that identifies the relationship. All records for the same USUBJID that have the same RELID are considered "related/associated." RELID can be any value the applicant chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records.
Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (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>