| Num | Field or Variable | Guidance |
|---|
| 1 | --YN | - Variables with the question text "Were there any <events>?" (e.g., “Were there any adverse events?”) support the cleaning of data and confirmation that there are no missing values.
- These questions can be used on any CRF.
- Values collected for these fields will not be represented in subsequent tabulation datasets.
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| 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 of an event 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 | --OCCUR | - --OCCUR may be used when a specific event is solicited (preprinted) on the CRF and the CRF uses an applicant-defined codelist.
- --OCCUR may be implemented while also allowing for a "NOT DONE" response.
|
| 5 | --REASND | - --REASND is used with tabulation variable --STAT.
- The value "NOT DONE" in --STAT indicates that the subject was not questioned about the event or that data were not collected; it does not mean that the subject had no events.
| Jira |
|---|
| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-422 |
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| 6 | --SPID | - --SPID may be populated by the applicant'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.
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| 7 | Coding | - The collection variables used for coding are not data collection fields that will appear on the CRF. Applicants will populate values through the coding process.
| Jira |
|---|
| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-423 |
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- When free-text event terms are entered, the location may be included in --TERM to facilitate coding and further clarify the event. This location information does not need to be removed from the verbatim term when creating tabulation datasets.
- The CDASH variables --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --SOC, and --SOCCD are only applicable to events coded in MedDRA.
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| 8 | Location (--LOC, --LAT, --DIR, --PORTOT) | - Location is collected when the applicant needs to identify the specific anatomical location of the event.
- Applicants may collect location data using a subset list of controlled terminology on the CRF.
- Applicants may prepopulate hidden variables with values assigned within their operational database.
- There is currently some overlap across controlled terminology for LOC, LAT, and DIR. While the overlap exists, ensure that this overlap is not part of database design.
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