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

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

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 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
Record QualifierDomain abbreviation of the parent record(s). Null for comments collected as a general comment or additional information.Exp
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID.Exp
POOLIDPool IdentifierChar
IdentifierIdentifier used for pooled subjects to assign a single result to multiple subjects. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID.Perm
COSEQSequence NumberNum
IdentifierThe sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.Req
IDVARIdentifying VariableChar
Record QualifierVariable in the parent dataset that identifies the record(s) to which the comment applies, which is contained in IDVAR. Examples: BWSEQ or CLGRPID. Used only when individual comments are related to domain records.Exp
IDVARVALIdentifying Variable ValueChar
Record QualifierValue of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Cannot be populated if IDVAR is null.Exp
COREFComment ReferenceChar
Record Qualifier

Applicant-defined reference associated with the comment. May be the logbook page number, name (e.g., Logbook), or a combination of information that identifies the reference (e.g., Logbook, page 650, Day 28, morning).

Perm
COVALCommentChar
TopicThe text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.Req
COEVALEvaluatorChar
Record QualifierUsed to describe the originator of the comment. Examples: TECHNICIAN, STUDY DIRECTOR, VET.Perm
CODTCDate/Time of CommentCharISO 8601 datetime or intervalTimingDate/Time of the comment, in ISO 8601 format. May be null if this is a child record of another domain or if the comment date was not collected. In all other cases, this represents the date/time of the comment in ISO 8601 format.Exp
CODYStudy Day of CommentNum
TimingStudy day of the comment, in integer days. May be null if this is a child record of another domain or if the comment date was not collected. 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 SEND domains. Comments are generally not responses to specific questions; instead, they usually consist of voluntary, free-text, or unsolicited observations.
  2. When RDOMAIN and USUBJID are not populated, it is assumed that a comment pertains to a study as a whole.
  3. The CO dataset accommodates 3 sources of comments:
    1. 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).
    2. 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.
    3. 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 USUBJID, IDVAR, and IDVARVAL are null. CODTC should be populated if captured.
  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 represented as needed to COVALn. Note: When using COVAL1-COVALn, the variable label should match the corresponding variable name (e.g., Comment1, Comment2).
  5. See Section 2.8.5.4, Relating Comments to a Domain, for additional information about how to relate comments to parent records.
  6. The following identifier and timing variables are permissible and may be added as appropriate when comments are not related to other domain records: COGRPID, COREF, COREFID, COSPID, TAETORD, CODY, COTPT, COTPTNUM, COELTM, COTPTREF, and CORFTDTC.

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