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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist, or Format
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study.
Req
DOMAIN
Domain Abbreviation
Char
CO
Identifier
Two-character abbreviation for the domain.
Req
RDOMAIN
Related Domain Abbreviation
Char
Record Qualifier
Domain abbreviation of the parent record(s). Null for comments collected as a general comment or additional information.
Exp
USUBJID
Unique Subject Identifier
Char
Identifier
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID.
Exp
POOLID
Pool Identifier
Char
Identifier
Identifier used for pooled subjects to assign a single result to multiple subjects. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID.
Perm
COSEQ
Sequence Number
Num
Identifier
The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.
Req
IDVAR
Identifying Variable
Char
Record Qualifier
Variable in the parent dataset that identifies the record(s) to which the comment applies, which is contained in IDVAR. Examples: BWSEQ or CLGRPID. Used only when individual comments are related to domain records.
Exp
IDVARVAL
Identifying Variable Value
Char
Record Qualifier
Value of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Cannot be populated if IDVAR is null.
Exp
COREF
Comment Reference
Char
Record Qualifier
Applicant-defined reference associated with the comment. May be the logbook page number, name (e.g., Logbook), or a combination of information that identifies the reference (e.g., Logbook, page 650, Day 28, morning).
Perm
COVAL
Comment
Char
Topic
The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.
Req
COEVAL
Evaluator
Char
Record Qualifier
Used to describe the originator of the comment. Examples: TECHNICIAN, STUDY DIRECTOR, VET.
Perm
CODTC
Date/Time of Comment
Char
ISO 8601
Timing
Date/Time of the comment, in ISO 8601 format. May be null if this is a child record of another domain or if the comment date was not collected. In all other cases, this represents the date/time of the comment in ISO 8601 format.
Exp
CODY
Study Day of Comment
Num
Timing
Study day of the comment, in integer days. May be null if this is a child record of another domain or if the comment date was not collected. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.