Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 CO 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 CO 2 DOMAIN Domain Abbreviation Char CO Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 CO 3 RDOMAIN Related Domain Abbreviation Char Record Qualifier 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
SDTMIG 3.3 CO 4 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
SDTMIG 3.3 CO 5 COSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 CO 6 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
SDTMIG 3.3 CO 7 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
SDTMIG 3.3 CO 8 COREF Comment Reference Char Record Qualifier 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). Perm
SDTMIG 3.3 CO 9 COVAL Comment Char Topic The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. See Assumption 3. Req
SDTMIG 3.3 CO 10 COEVAL Evaluator Char Record Qualifier Used to describe the originator of the comment. Examples: CENTRAL, REVIEWER, ADJUDICATION COMMITTEE, PRINCIPAL INVESTIGATOR. Perm
SDTMIG 3.3 CO 11 COEVALID Evaluator Identifier Char (MEDEVAL) Record Qualifier Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST, RADIOLOGIST1, RADIOLOGIST2. Perm
SDTMIG 3.3 CO 12 CODTC Date/Time of Comment Char ISO 8601 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
SDTMIG 3.3 CO 13 CODY Study Day of Comment Num Timing 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. Perm