Comments are collected during the conduct of many studies. These are normally supplied by a principal investigator, but might also be collected from other sources such as central reviewers. When collected, comments should be submitted in a single Comments domain, defined here.
See the implementation guides referenced in Section 1.2, Implementation Advice for this Model, for further guidance regarding use of additional identifier and timing variables.
Comments Domain Variables
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 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 Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "CO". | ||||
| 3 | RDOMAIN | Related Domain Abbreviation | Char | Record Qualifier | Domain abbreviation of the parent record(s). Null for records collected on general comments or additional information section of CRF. | ||||||
| 4 | USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | |||||
| 5 | POOLID | Pool Identifier | Char | Identifier | C117053 | A sequence of characters used to uniquely identify a group of subjects that have been pooled together. | The result is not assignable to any one individual. | ||||
| 6 | SPDEVID | Sponsor Device Identifier | Char | Identifier | C117060 | A sequence of characters used by the sponsor to uniquely identify a specific device. | |||||
| 7 | COSEQ | Sequence Number | Num | Identifier | Sequence number to ensure uniqueness within the dataset. | ||||||
| 8 | IDVAR | Identifying Variable | Char | Record Qualifier | Identifying variable in the parent dataset that identifies the record(s) to which the comment applies (e.g., AESEQ, CMGRPID). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs. | ||||||
| 9 | IDVARVAL | Identifying Variable Value | Char | Record Qualifier | Value of identifying variable of the parent record(s). Null for comments collected on separate CRFs. | ||||||
| 10 | COREF | Comment Reference | Char | Record Qualifier | Sponsor-defined reference associated with the comment. | A CRF page number (e.g., 650), a module name (e.g., "DEMOG"), or a combination of information that identifies the reference (e.g., "650-VITALS-VISIT 2") | |||||
| 11 | COVAL | Comment | Char | Topic | The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. | ||||||
| 12 | COEVAL | Evaluator | Char | Record Qualifier | Used to describe the originator of the comment. | "CENTRAL REVIEWER" | |||||
| 13 | COEVALID | Evaluator Identifier | Char | Variable Qualifier | COEVAL | Used to distinguish multiple evaluators with the same role recorded in --EVAL. | "RADIOLOGIST1", "RADIOLOGIST2" | ||||
| 14 | CODTC | Date/Time of Comment | Char | ISO 8601 datetime or interval | Timing | Date or date and time of comment on dedicated comment form, if collected. Should be null if this is a child record of another domain or if comment date was not collected. | |||||
| 15 | CODY | Study Day of Comment | Num | Timing | Actual 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. |
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