Substance use information may be independent of planned study evaluations, or may be a key outcome (e.g., planned evaluation) of a clinical trial.
- In many clinical trials, detailed substance use information as provided for in the domain model above may not be required (e.g., the only information collected may be a response to the question “Have you ever smoked tobacco?”); in such cases, many of the qualifier variables would not be submitted.
- SU may contain responses to questions about use of prespecified substances as well as records of substance use collected as free text.
- SU description and coding
- SUTRT captures the verbatim or the prespecified text collected for the substance. It is the topic variable for the SU dataset. SUTRT is a required variable and must have a value.
- SUMODIFY is a permissible variable and should be included if coding is performed and the sponsor’s procedure permits modification of a verbatim substance use term for coding. The modified term is listed in SUMODIFY. The variable may be populated as per the sponsor’s procedures.
- SUDECOD is the preferred term derived by the sponsor from the coding dictionary if coding is performed. It is a permissible variable. Where deemed necessary by the sponsor, the verbatim term (SUTRT) should be coded using a standard dictionary such as WHO Drug. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document.
- Additional categorization and grouping
- SUCAT and SUSCAT should not be redundant with the domain code or dictionary classification provided by SUDECOD, or with SUTRT. That is, they should provide a different means of defining or classifying SU records. For example, a sponsor may be interested in identifying all substances that the investigator feels might represent opium use, and to collect such use on a separate CRF page. This categorization might differ from the categorization derived from the coding dictionary.
- SUGRPID may be used to link (or associate) different records together to form a block of related records within SU at the subject level (see Section 4.2.6, SEND - Grouping Variables and Categorization). It should not be used in place of SUCAT or SUSCAT.
- Timing variables
- SUSTDTC and SUENDTC may be populated as required.
- If substance use information is collected more than once within the CRF (indicating that the data are visit-based) then VISITNUM would be added to the domain as an additional timing variable. VISITDY and VISIT would then be permissible variables.
- Any additional qualifiers from the Interventions class may be added to the SU domain, but the following qualifiers would generally not be used: --MOOD, --LOT.
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