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  1.  Categories SUCAT and SUSCAT
    1. Sponsors may require different types of substance-use data (e.g., illicit drug use, cigarettes) to be collected; the value for category may be preprinted on the CRF.
    2. SUCAT and SUSCAT should not be redundant with SUTRT. For example, if a more detailed type of substance usage is collected on the CRF (e.g., “CIGARETTES”, “CIGARS”), SUCAT should be “TOBACCO” and SUTRT could be “CIGARETTES”, "CIGARS".  If the sponsor does not solicit responses about specific types of substances used on the CRF (e.g., “CIGAR”, “CIGARETTE”), the value of SUTRT is the more general description of the substance (e.g., “TOBACCO") and SUCAT is generally null. This practice avoids assigning the same value to both SUTRT and SUCAT. However, for consistency across studies, the sponsor may elect to repeat the values of SUTRT in SUCAT.
  3. The SDTMIG variable SUPRESP should be prepopulated to the value of "Y" when information about the use of a specific substance is solicited on the CRF.
  4. Relative Timing Variables
    1. Relative timing variables are used to represent collected data in the SDTM tabulations in those cases where a start date or an end date has not been collected, but some indication of when/if the intervention or event started or ended has been collected. In the CDASHIG SU domain, if the CDASHIG variable SUNCF is used (with the possible responses of "Never", "Current", and "Former"), the collected values may be used to derive a value into an SDTMIG relative timing variable to represent when the subject started or stopped using the substance relative to either a time point or to a period of time in the study. 
      For example, if the value collected in SUNCF is "Current", the value of "ONGOING" may be represented in the SDTMIG Variable SUENRTPT to indicate that the subject was still using cigarettes as of the time point described in SUENTPT. It is recommended that the sponsor collect either a date or a description of a time point that will be used in conjunction with relative timing variables. See the SDTMIG for more information about relative timing variables.
    2. If the actual, complete start date or end date of the substance use has been collected, there is no need to use relative timing variables.
  5. Start and End Dates
    1. Start and end dates can be collected if this level of detail is required by the protocol. Partial dates may be collected when the subject does not remember the complete date of when substance use started or ended. The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year, year).
    2. Sponsors may elect to capture only a start date, or only an end date, and use the associated SDTMIG relative timing variables to represent information about the date not collected.
    3. If the sponsor is only interested in collecting whether or not the subject is consuming a particular substance, start and end dates are optional and may be omitted, and SUNCF may be collected as described above.
  6. Coding
    1. Coding may be performed if deemed necessary by the sponsor. The SDTMIG variable SUDECOD is a permissible variable in the SDTMIG SU domain.
    2. Coding variables are not usually displayed on CRFs. If a sponsor chooses to display coding on the form, CDASH does not advocate using that as a field for entry by site personnel.
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