The CDASHIG SU domain is used to collect information on substance use when the information is relevant to the assessment of the efficacy and safety of therapies. The amount of information collected for this domain depends upon the sponsor'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.
CDASH recommends the use of the more descriptive CDASHIG variable SUNCF with responses of “Never," "Current," or "Former” for each substance use type, rather than a simple "Yes/No" response. Based on the wide variability of protocol definitions of use, the specific definitions and timeframes for the SUNCF responses would be sponsor/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.
This CRF is for tobacco use. The user will need to update the category, as appropriate. This CRF is used for substances taken by the subject, and not any environmental factors. For additional information, please refer to the implementation notes in CDASHIG.
SU_eCRF_Package