Comments

Comments are collected during the conduct of many studies. These are normally supplied by a principal investigator, but might also be collected from other sources such as central reviewers. When collected, comments should be submitted in a single Comments domain, defined here.

See the implementation guides for further guidance regarding use of additional identifier and timing variables.

Comments Domain Variables

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

#	Variable Name	Variable Label	Type	Format	Role	Variable(s) Qualified	Variable C-code	Definition	Notes	Examples
1	STUDYID	Study Identifier	Char		Identifier		C83082	A sequence of characters used by the sponsor to uniquely identify the study.
2	DOMAIN	Domain Abbreviation	Char		Identifier		C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "CO".
3	RDOMAIN	Related Domain Abbreviation	Char		Record Qualifier				Domain abbreviation of the parent record(s). Null for records collected on general comments or additional information section of CRF.
4	USUBJID	Unique Subject Identifier	Char		Identifier		C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.
5	POOLID	Pool Identifier	Char		Identifier		C117053	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.	The result is not assignable to any one individual.
6	SPDEVID	Sponsor Device Identifier	Char		Identifier		C117060	A sequence of characters used by the sponsor to uniquely identify a specific device.
7	COSEQ	Sequence Number	Num		Identifier				Sequence number to ensure uniqueness within the dataset.
8	IDVAR	Identifying Variable	Char		Record Qualifier				Identifying variable in the parent dataset that identifies the record(s) to which the comment applies (e.g., AESEQ, CMGRPID). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs.
9	IDVARVAL	Identifying Variable Value	Char		Record Qualifier				Value of identifying variable of the parent record(s). Null for comments collected on separate CRFs.
10	COREF	Comment Reference	Char		Record Qualifier				Sponsor-defined reference associated with the comment.	A CRF page number (e.g., 650), a module name (e.g., "DEMOG"), or a combination of information that identifies the reference (e.g., "650-VITALS-VISIT 2")
11	COVAL	Comment	Char		Topic				The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.
12	COEVAL	Evaluator	Char		Record Qualifier				Used to describe the originator of the comment.	"CENTRAL REVIEWER"
13	COEVALID	Evaluator Identifier	Char		Variable Qualifier	COEVAL			Used to distinguish multiple evaluators with the same role recorded in --EVAL.	"RADIOLOGIST1", "RADIOLOGIST2"
14	CODTC	Date/Time of Comment	Char	ISO 8601 datetime or interval	Timing				Date or date and time of comment on dedicated comment form, if collected. Should be null if this is a child record of another domain or if comment date was not collected.
15	CODY	Study Day of Comment	Num		Timing				Actual 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.

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Comments