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  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). Assumptions for populating IDVAR and IDVARVAL are further described in Section 8.2, Relating Records - RELREC.
    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. (See Example 1, rows 8-9.)
    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. (See Example 1, row 10.)
  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. (See Example 1, row 7). Note: When using COVAL1-COVALn, the variable label should match the corresponding variable name (e.g., Comment1, Comment2).
  5. See Section 8.2, Relating Records - RELREC, 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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