Comments
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): CO
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page. Controlled Terms or Format (if applicable): NA, extensible
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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). Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. See Assumption 3. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to describe the originator of the comment. Examples: CENTRAL, REVIEWER, ADJUDICATION COMMITTEE, PRINCIPAL INVESTIGATOR. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST, RADIOLOGIST1, RADIOLOGIST2. Controlled Terms or Format (if applicable): (MEDEVAL), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
integer