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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 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 Record Qualifier Perm Used to describe the originator of the comment. Examples: CENTRAL, REVIEWER, ADJUDICATION COMMITTEE, PRINCIPAL 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, RADIOLOGIST1, RADIOLOGIST2.
12 CO CODTC Date/Time of Comment Char ISO 8601 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.