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Description/Overview

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 applicant's protocol. 

Using collection 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 definitions of use, the specific definitions and timeframes for the SUNCF responses would be applicant/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.

Specification

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Observation ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable LabelDRAFT Collection DefinitionQuestion TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
InterventionsSUN/AN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.
InterventionsSUN/AN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site.

EDC: This should be pre-populated.

InterventionsSUN/AN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.

InterventionsSUN/AN/A4SUTRTReported Name of SubstanceThe type of substance (e.g., TOBACCO, ALCOHOL, CAFFEINE or CIGARETTES, CIGARS, COFFEE).What [is/was] the [name/type] of (the) substance used?[Type of Substance]CharHRN/ASUTRTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicants may require different types of substance-use data (e.g., illicit drug use, cigarettes); the value for category may be pre-printed on the CRF as a label for the prompt for Substance Use. If a more detailed type of substance appears on the CRF (e.g., CIGARETTES, CIGARS rather than TOBACCO), SUCAT should be TOBACCO and SUTRT should be CIGARETTES.
InterventionsSUN/AN/A5SUCATCategory for Substance UseA grouping of topic-variable values based on user-defined characteristics.What is/was the category of the substance (used)?[Substance (Used) Category]; NULLCharR/CRecord the Substance Used category, if not pre-printed on the CRF.SUCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology (e.g., TOBACCO, ALCOHOL, CAFFEINE). Applicants may require different types of substance-use data (e.g., illicit drug use, cigarettes); the value for category may be pre-printed on the CRF. If a more detailed type of substance appears on the CRF (e.g., CIGARETTES, CIGARS, rather than TOBACCO), SUCAT is TOBACCO and SUTRT is CIGARETTES. If the applicant does not specify a type of tobacco on the CRF, SUTRT is TOBACCO. If SUCAT is not collected (e.g., it is evident from the protocol design), it could be populated during the tabulation dataset creation process.
InterventionsSUN/AN/A6SUSCATSubcategory for Substance UseA sub-division of the SUCAT values based on user-defined characteristics.What was the subcategory of the substance (used)?[Substance (Used) Subcategory]; NULLCharORecord the Substance Use subcategory, if not pre-printed on the CRF.SUSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology. The value for subcategory may be pre-printed on the CRF or hidden. SUSCAT can only be used if there is a SUCAT and it must be a subcategorization of SUCAT.
InterventionsSUN/AN/A7SUPRESPSU PrespecifiedAn indication that a specific intervention or a group of interventions is prespecified on a CRF.N/AN/ACharON/ASUPRESPMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AFor pre-specified interventions, a hidden field on a CRF defaulted to "Y", or added during the tabulation dataset creation. If a study collects both pre-specified and free-text interventions, the value of SUPRESP should be "Y" for all prespecified interventions and null for interventions reported as free text.
InterventionsSUN/AN/A8SUYNAny Substance UsedAn indication of whether any data was collected for the intervention topic.Were any [applicant-phrase/substance name/recreational drugs] used?Any [Substance Name (Used)]CharOIndicate if the subject had used any (applicant-defined phrase/recreational drugs/alcohol/substance name).N/ADoes not map to a tabulation variable.(NY)N/AGeneral prompt question to aid in monitoring and data cleaning. This provides verification that all other fields on the CRF were deliberately left blank. This is a field that can be used on any Interventions CRF to indicate whether there is data to record.
InterventionsSUN/AN/A9SUNCFNever Current Former UsageIndication the pre-specified substance was used.Has the subject ever [used/consumed] [SUTRT/SUCAT]?([Substance]) UsageCharR/CCheck the appropriate box to indicate if the subject has ever used/consumed tobacco/alcohol/caffeine, currently consumes tobacco/alcohol/caffeine, or formerly used/consumed tobacco/alcohol/caffeine.SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF; SUPPSU.QVALThis does not map directly to a tabulation variable. May be used to populate SUOCCUR and relative timing variables.(NCF)(SUNCF)

The 3 options (NEVER, CURRENT, FORMER) are applicant-defined in relation to the protocol. If the applicant has specific definitions, these definitions are detailed in the instructions to the site. As this type of response does not correspond exactly to a tabulation variable, collection variable SUNCF is recommended. Applicants must decide how to populate the appropriate relative timing variables when creating the tabulation datasets. For example, If SUNCF ="Never", the value of SUOCCUR will be "N" and all relative timing variables will be null. If the applicant chooses to populate the relative start references (SUSTRTPT, SUSTRF) the value will be "BEFORE" when SUNCF= "CURRENT" and "FORMER". If the applicant also chooses to use relative end references (SUENRF, SUENRTPT), the SUENRTPT value will be "ONGOING" when SUNCF="CURREN" while the value of SUENRF will be "DURING/AFTER".

Note: When using SUSTRTPT and/or SUENRTPT, these must refer to a time-point anchor (e.g., SCREENING, in SUSTTPT/SUENTPT).

InterventionsSUN/AN/A10SUSPIDSubstance Use Applicant-Defined IdentifierA applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.

[Applicant-defined question]

[Applicant defined]CharOIf collected on the CRF, applicants may insert instructions to ensure each record has a unique identifier.SUSPIDMaps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.N/AN/ABecause SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system.
InterventionsSUN/AN/A11SUREASNDReason Substance Use Not CollectedAn explanation for why data are not available.What was the reason the data was not collected?Reason Not CollectedCharOProvide the reason why the substance used data were not collected.SUREASNDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe reason data are not available may be chosen from an applicant-defined list (e.g., subject refused) or entered as free text. When PRREASND is used, the tabulation variable PRSTAT should also be populated in the tabulation dataset.
InterventionsSUN/AN/A12SUDSTXTSubstance Dose DescriptionThe amount of substance used (e.g., 1-2 packs, 8 oz).What is/was the amount of [SUTRT] used/consumed?AmountCharOCheck the appropriate box to indicate the amount of tobacco/alcohol/caffeine the subject consumes on a regular basis.SUDOSE; SUDOSU; SUDOSTXTThis does not map directly to a tabulation variable. Numeric values map to SUDOSE in the tabulation dataset. Non-numeric values (e.g., 200-400) map to SUDOSTXT in the tabulation dataset.N/AN/AWhere possible, the options for dose/amount are pre-printed on the CRF. In the example given in the definition, "packs" and "ounces" are included as a point of reference. They would be represented as SUDOSU. Care should be taken to map each record to the appropriate tabulation variable SUDOSTXT (text results that cannot be represented in a numeric field) and SUDOSE (numeric results).
InterventionsSUN/AN/A13SUDOSFRQSubstance Use Frequency per IntervalThe number/amount of the of substance consumed per a specific interval.What [is/was] the frequency of [SUTRT] [use/consumption]?FrequencyCharORecord how often the subject regularly [uses / consumes] (the) [substance].SUDOSFRQMaps directly to the tabulation variable listed in the Tabulation Target column.(FREQ)N/AWhen possible, the options for dose/amount frequency are pre-printed on the CRF. (e.g., PER DAY, PER WEEK, OCCASIONAL).
InterventionsSUN/AN/A14SUSTDATSubstance Use Start DateThe date substance use started, represented in an unambiguous date format (e.g., DD-MON-YYYY.What was the start date of [SUTRT/SUCAT] use/consumption?Start DateCharORecord the start date of the substance use using this format (DD-MON-YYYY).SUSTDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable SUSTDTC in ISO 8601 format.N/AN/AThe applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year).
InterventionsSUN/AN/A15SUENDATSubstance Use End DateThe date substance use ended, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the end date of [SUTRT/SUCAT] use/consumption?End DateCharORecord the end date of the substance use using this format (DD-MON-YYYY).SUENDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable SUENDTC in ISO 8601 format.N/AN/AThe applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year).
InterventionsSUN/AN/A16SUCDURSubstance Use Collected DurationCollected duration of the substance use.What was the duration of [SUTRT/SUCAT] use/consumption?DurationCharOProvide the duration of the substance use (e.g., Record how long the subject has smoked).SUDURThis does not map directly to a tabulation variable. For the tabulation dataset, concatenating the collected duration and collected duration unit and populate the tabulation variable SUDUR in ISO 8601 format. Example: P1DT2H (for 1 day, 2 hours).N/AN/AThis is only collected on the CRF if this level of detail is needed and if SUSTDAT and SUENDAT are not collected on the CRF.
InterventionsSUN/AN/A17SUCDURUSubstance Use Collected Duration UnitUnit of the collected duration of the substance use. Used only if duration was collected on the CRF.What was the unit of duration of [SUTRT/SUCAT] use/consumption?(Duration) UnitCharOSelect the appropriate duration unit of the substance use.SUDURThis does not map directly to a tabulation variable. For the tabulation dataset, concatenating the collected duration and collected duration unit and populate the tabulation variable SUDUR in ISO 8601 format. Example: P1DT2H (for 1 day, 2 hours).(UNIT)N/AApplicant-defined options should be pre-printed on the CRF to avoid making this a free-text field. This will allow the response to be translated into ISO 8601 format.
InterventionsSUN/AN/A18SUMODIFYModified Substance NameIf the value for SUTERM is modified for coding purposes, then the modified text is placed here.N/AN/ACharON/ASUMODIFYMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis is not a data collection field that would appear on the CRF. If the applicant chooses to code the substance use, the applicant will populate this through the coding process.
InterventionsSUN/AN/A19SUDECODStandardized Substance NameThe dictionary or applicant-defined standardized text description of SUTRT, or the modified topic variable (SUMODIFY), if applicable.N/AN/ACharON/ASUDECODMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis is typically not a data collection field that will appear on the CRF. If the applicant chooses to code the substance use, the applicant will populate this through the coding process. Equivalent to the generic drug name in published (e.g., WHODrug, SNOMED, ICD9) or applicant-defined dictionaries. If SUPRESP is used, and the information about a specific standardized substance name is being solicited, the data from SUTRT may map directly to the tabulation SUDECOD variable.

Assumptions

  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. 
  2. 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.
  3. 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.
  4. 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.
  5. 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.

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