| Num | Collection Variable Use | Implementation |
|---|
| 1 | --YN | - --YN ("Yes/No") questions are used to provide a definite answer. The absence of a response is ambiguous as it can mean "no," "none," or that the response is missing.
- Variables with the question text "Were there any interventions?" (e.g., “Were there any concomitant medications?") support the cleaning of data and confirmation that entry of collected data is complete.
- Values collected for these fields will not be represented in subsequent tabulation datasets.
|
| 2 | --CAT, --SCAT | - Categories and subcategories are determined per protocol design and values are generally not entered via CRF.
- Implementers may:
- Prepopulate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF.
- Prepopulate hidden variables with the values assigned within their operational database.
- Populate values directly in the tabulation dataset during dataset creation.
|
| 3 | Variables for date and time | - The time an intervention started will be collected if there is a scientific or regulatory reason to collect this level of detail and the time can be realistically determined.
- Collection variables for date (e.g., --DAT, --STDAT, --ENDAT) will be concatenated with collection variables for time (e.g., --TIM, --STTIM, --ENTIM) as applicable to populate tabulation variables for dates (e.g., --DTC, --STDTC, --ENDTC) using ISO 8601 format.
|
| 4 | -- REASND | - --REASND is used with tabulation variable --STAT.
- The value "NOT DONE" in --STAT indicates that the subject was not questioned about the intervention or that data were not collected; it does not mean that the subject had no interventions.
|
| 5 | --SPID | - --SPID may be populated by the implementer's data collection system.
- If collected, --SPID it can be used as an identifier in a data query to communicate clearly to individuals involved in data collection the record in question.
|
| 6 | Coding | - When free-text interventions/treatments are recorded, the location may be included in the --TRT variable to facilitate coding (e.g., lung biopsy). Location may be collected when the implementer needs to identify the specific anatomical location of the intervention. This location information does not need to be removed from the verbatim --TRT when creating tabulation datasets.
- The non-standard variables --ATC1 through --ATC5 and --ATC1CD through --ATC5CD are used only when the intervention is coded using the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system (https://www.who.int/medicines/regulation/): 1 = the anatomical main group, 2 = the therapeutic main group, 3 = the therapeutic/pharmacological subgroup, 4 = chemical/therapeutic/pharmacological subgroup, 5 = chemical substance.
- Implementers may add MedDRA coding elements as NSVs to the Interventions domain if that dictionary is used for coding.
|
| 7 | Location (--LOC) and related variables (--LAT, --DIR, -- PORTOT) | - Applicants may collect location data using a subset list of controlled terminology on the CRF.
- Applicants may prepopulate hidden variables
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with variables with values assigned within their operational database.
|