Description

A special-purpose domain that contains comments that may be collected alongside other data.

co.xpt, Comments — Special-Purpose. One record per comment per subject, Tabulation.


Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharCOIdentifierTwo-character abbreviation for the domain.Req
RDOMAINRelated Domain AbbreviationChar(DOMAIN)Record QualifierTwo-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page.Perm
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
COSEQSequence NumberNum
IdentifierSequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
IDVARIdentifying VariableChar
Record QualifierIdentifying 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
IDVARVALIdentifying Variable ValueChar
Record QualifierValue 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
COREFComment ReferenceChar
Record QualifierApplicant-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
COVALCommentChar
TopicThe text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.Req
COEVALEvaluatorChar(EVAL)Record QualifierRole 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".Perm
COEVALIDEvaluator IdentifierChar(MEDEVAL)Record QualifierUsed to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: "RADIOLOGIST", "RADIOLOGIST 1", "RADIOLOGIST 2".Perm
CODTCDate/Time of CommentCharISO 8601 datetime or intervalTimingDate/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
CODYStudy Day of CommentNum
TimingStudy day of the comment, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm


Assumptions

  1. The Comments special-purpose domain provides a solution for submitting free-text comments related to data in 1 or more SDTM domains (as described in Section 2.8.5.4, Relating Comments to a Domain) or collected on a separate CRF page dedicated to comments. Comments are generally not responses to specific questions; instead, comments usually consist of voluntary free-text or unsolicited observations.
  2. Although the structure for the Comments domain in the SDTM is "One record per comment", USUBJID is required in the comments domain for human clinical studies, so the structure of the Comments domain in the TIG is "One record per comment per subject."
  3. The CO dataset accommodates 3 sources of comments:
    1. Those unrelated to a specific domain or parent record(s), in which case the values of the variables RDOMAIN, IDVAR, and IDVARVAL are null. CODTC should be populated if captured.
    2. Those related to a domain but not to specific parent record(s), in which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent domain and the variables IDVAR and IDVARVAL are null. CODTC should be populated if captured.
    3. Those related to a specific parent record or group of parent records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated with the key variable name and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described in Section 2.8.5.4, Relating Comments to a Domain.
    4. CODTC should be null because the timing of the parent record(s) is inherited by the comment record.
  4. When the comment text is longer than 200 characters, the first 200 characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed to COVALn. See Example 1, rows 3-4. Additional information about how to relate comments to parent SDTM records is provided in Section 2.8.5.4, Relating Comments to a Domain.
  5. The variable COREF may be null unless it is used to identify the source of the comment.
  6. Identifier variables and Timing variables may be added to the CO domain, but the following qualifiers would generally not be used in CO: --GRPID, --REFID, --SPID, TAETORD, --TPT, --TPTNUM, --ELTM, --TPTREF, --RFTDTC.

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