SDTM.CO

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	CO	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	CO	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	CO	RDOMAIN	Related Domain Abbreviation	Char	C66734	Record Qualifier	Perm	Two-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page.
4	CO	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
5	CO	COSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
6	CO	IDVAR	Identifying Variable	Char		Record Qualifier	Perm	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.
7	CO	IDVARVAL	Identifying Variable Value	Char		Record Qualifier	Perm	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.
8	CO	COREF	Comment Reference	Char		Record Qualifier	Perm	Sponsor-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).
9	CO	COVAL	Comment	Char		Topic	Req	The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. See Assumption 3.
10	CO	COEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	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".
11	CO	COEVALID	Evaluator Identifier	Char	C96777	Record Qualifier	Perm	Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: "RADIOLOGIST", "RADIOLOGIST 1", "RADIOLOGIST 2".
12	CO	CODTC	Date/Time of Comment	Char	ISO 8601 datetime or interval	Timing	Perm	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.
13	CO	CODY	Study Day of Comment	Num		Timing	Perm	Study day of the comment, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.