| Observation Class | Domain | Data Collection Scenario | Implementation Options | Order Number | Collection Variable | Collection Variable Label | DRAFT Collection Definition | Question Text | Prompt | Data Type | Collection Core | Case Report Form Completion Instructions | Tabulation Target | Mapping Instructions | Controlled Terminology Codelist Name | Subset Controlled Terminology/CDASH Codelist Name | Implementation Notes |
| Interventions | SU | N/A | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although 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. |
| Interventions | SU | N/A | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Interventions | SU | N/A | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Interventions | SU | N/A | N/A | 4 | SUTRT | Reported Name of Substance | The 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] | Char | HR | N/A | SUTRT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | 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 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. |
| Interventions | SU | N/A | N/A | 5 | SUCAT | Category for Substance Use | A grouping of topic-variable values based on user-defined characteristics. | What is/was the category of the substance (used)? | [Substance (Used) Category]; NULL | Char | R/C | Record the Substance Used category, if not pre-printed on the CRF. | SUCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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. |
| Interventions | SU | N/A | N/A | 6 | SUSCAT | Subcategory for Substance Use | A sub-division of the SUCAT values based on user-defined characteristics. | What was the subcategory of the substance (used)? | [Substance (Used) Subcategory]; NULL | Char | O | Record the Substance Use subcategory, if not pre-printed on the CRF. | SUSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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. |
| Interventions | SU | N/A | N/A | 7 | SUPRESP | SU Prespecified | An indication that a specific intervention or a group of interventions is prespecified on a CRF. | N/A | N/A | Char | O | N/A | SUPRESP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | For 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. |
| Interventions | SU | N/A | N/A | 8 | SUYN | Any Substance Used | An indication of whether any data was collected for the intervention topic. | Were any [applicant-phrase/substance name/recreational drugs] used? | Any [Substance Name (Used)] | Char | O | Indicate if the subject had used any (applicant-defined phrase/recreational drugs/alcohol/substance name). | N/A | Does not map to a tabulation variable. | (NY) | N/A | General 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. |
| Interventions | SU | N/A | N/A | 9 | SUNCF | Never Current Former Usage | Indication the pre-specified substance was used. | Has the subject ever [used/consumed] [SUTRT/SUCAT]? | ([Substance]) Usage | Char | R/C | Check 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.QVAL | This 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). |
| Interventions | SU | N/A | N/A | 10 | SUSPID | Substance Use Applicant-Defined Identifier | A 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] | Char | O | If collected on the CRF, applicants may insert instructions to ensure each record has a unique identifier. | SUSPID | Maps 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/A | N/A | Because 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. |
| Interventions | SU | N/A | N/A | 11 | SUREASND | Reason Substance Use Not Collected | An explanation for why data are not available. | What was the reason the data was not collected? | Reason Not Collected | Char | O | Provide the reason why the substance used data were not collected. | SUREASND | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The 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. |
| Interventions | SU | N/A | N/A | 12 | SUDSTXT | Substance Dose Description | The amount of substance used (e.g., 1-2 packs, 8 oz). | What is/was the amount of [SUTRT] used/consumed? | Amount | Char | O | Check the appropriate box to indicate the amount of tobacco/alcohol/caffeine the subject consumes on a regular basis. | SUDOSE; SUDOSU; SUDOSTXT | This 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/A | N/A | Where 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). |
| Interventions | SU | N/A | N/A | 13 | SUDOSFRQ | Substance Use Frequency per Interval | The number/amount of the of substance consumed per a specific interval. | What [is/was] the frequency of [SUTRT] [use/consumption]? | Frequency | Char | O | Record how often the subject regularly [uses / consumes] (the) [substance]. | SUDOSFRQ | Maps directly to the tabulation variable listed in the Tabulation Target column. | (FREQ) | N/A | When possible, the options for dose/amount frequency are pre-printed on the CRF. (e.g., PER DAY, PER WEEK, OCCASIONAL). |
| Interventions | SU | N/A | N/A | 14 | SUSTDAT | Substance Use Start Date | The 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 Date | Char | O | Record the start date of the substance use using this format (DD-MON-YYYY). | SUSTDTC | This 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/A | N/A | The applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year). |
| Interventions | SU | N/A | N/A | 15 | SUENDAT | Substance Use End Date | The 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 Date | Char | O | Record the end date of the substance use using this format (DD-MON-YYYY). | SUENDTC | This 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/A | N/A | The applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year). |
| Interventions | SU | N/A | N/A | 16 | SUCDUR | Substance Use Collected Duration | Collected duration of the substance use. | What was the duration of [SUTRT/SUCAT] use/consumption? | Duration | Char | O | Provide the duration of the substance use (e.g., Record how long the subject has smoked). | SUDUR | This 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/A | N/A | This is only collected on the CRF if this level of detail is needed and if SUSTDAT and SUENDAT are not collected on the CRF. |
| Interventions | SU | N/A | N/A | 17 | SUCDURU | Substance Use Collected Duration Unit | Unit 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) Unit | Char | O | Select the appropriate duration unit of the substance use. | SUDUR | This 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/A | Applicant-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. |
| Interventions | SU | N/A | N/A | 18 | SUMODIFY | Modified Substance Name | If the value for SUTERM is modified for coding purposes, then the modified text is placed here. | N/A | N/A | Char | O | N/A | SUMODIFY | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This 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. |
| Interventions | SU | N/A | N/A | 19 | SUDECOD | Standardized Substance Name | The dictionary or applicant-defined standardized text description of SUTRT, or the modified topic variable (SUMODIFY), if applicable. | N/A | N/A | Char | O | N/A | SUDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This 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. |