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  1.  Categories SUCAT and SUSCAT
    1. Applicants may require different types of substance-use data (e.g., illicit drug use, cigarettes, recreational drugs) 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 applicant 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 applicant may elect to repeat the values of SUTRT in SUCAT. 
      Jira
      showSummaryfalse
      serverIssue Tracker (JIRA)
      serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
      keyTOBA-727
  3. The tabulation 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 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 collection SU domain, if the collection variable SUNCF is used (with the possible responses of "Never", "Current", and "Former"), the collected values may be used to derive a value into a tabulation 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 tabulation variable SUENRTPT to indicate that the subject was still using cigarettes as of the time point described in SUENTPT. It is recommended that the applicant collect either a date or a description of a time point that will be used in conjunction with 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 applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year).
    2. Applicants may elect to capture only a start date, or only an end date, and use the associated tabulation relative timing variables to represent information about the date not collected.
    3. If the applicant 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 applicant. The tabulation variable SUDECOD is a permissible variable in the tabulation SU domain.
    2. Coding variables are not usually displayed on CRFs. If an applicant chooses to display coding on the form, it should not be used as a field for entry by site personnel.