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Description/Overview

This CDASHIG SU domain is used to collect information on substance use when this is relevant to the assessment of the efficacy and safety of therapies. The Substance Use (SU) is an Interventions domain used for information on the use of recreational products such as caffeine, alcohol, tobacco/nicotine, and other recreational drugs that may be of interest to the study. The amount of information collected for the SU domain depends upon regulatory requirements and the sponsorapplicant's protocol. In many protocols, only information on the use of the substance is required. In such cases, many of the variables in this domain (e.g., duration, amount) would not be collected. 

Using collection CDASH recommends the use of the more descriptive CDASHIG variable SUNCF with responses of “Never", "Current", and "Former” for each substance-use type, rather than a simple "Yes/No" response is recommended. Based on the wide variability of protocol definitions of use, the specific definitions and timeframes for the SUNCF responses would be sponsorapplicant/protocol-defined. By using the SUNCF response categories for usage, a number of questions about use and frequency can be collapsed, in turn decreasing the number of data points required in the SU domain. More detailed information about duration, amount, and start and end dates are optionally captured.

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