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Metadataspec |
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Num | Collection Variable Use | Implementation |
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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.
Jira |
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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-416 |
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- Values collected for these fields
Jira |
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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-586 |
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| 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.
Jira |
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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-417 |
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- 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
Jira |
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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-418 |
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| (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.
Jira |
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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-419 |
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| - The value "NOT DONE" in --STAT indicates that the subject was not questioned about the intervention or that data were not collected
Jira |
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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-363 |
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| ; it does not mean that the subject had no interventions.
| 5 | --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.
| 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 applicant 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
Jira |
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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-420 |
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| 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
Jira |
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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-421 |
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| with values assigned within their operational database. Note: CRF may contain uneditable fields. These fields are pre-determined, pre-printed, pre-specified, or otherwise fixed value used by the applicant but not entered by the user. This value may appear on the CRF or may not be shown (i.e hidden). - 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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The following assumptions will be implemented for Events class domains.
Metadataspec |
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Num | Field or Variable | Guidance |
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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 <events>?" (e.g., “Were there any adverse events?”) support the cleaning of data and confirmation that entry of collected data is complete.
- These questions can be used on any CRF.
- 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 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 |
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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.
| 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 |
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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-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.
| 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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The following assumptions will be implemented for Findings class domains.
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