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Release Notes
Two-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page.
Perm
USUBJID
Unique Subject Identifier
Char
Identifier
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
Req
COSEQ
Sequence Number
Num
Identifier
Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
Req
IDVAR
Identifying Variable
Char
Record Qualifier
Identifying 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
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. Null for comments collected on separate CRFs.
Perm
COREF
Comment Reference
Char
Record Qualifier
Applicant-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
COVAL
Comment
Char
Topic
The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.
Role 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".
Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: "RADIOLOGIST", "RADIOLOGIST 1", "RADIOLOGIST 2".
Perm
CODTC
Date/Time of Comment
Char
ISO 8601 datetime or interval
Timing
Date/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
CODY
Study Day of Comment
Num
Timing
Study 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.