Guidance in this section describes the intended population of data in tabulation dataset records and variables and will be used with domain-specific assumptions as appropriate.
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| Metadataspec |
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| Num | Variable Population | Implementation |
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| Multiple Values for a Topic Variable | Product Impact on Individual Health Only: Interventions and events class datasets will conform with the record structure defined for the domain. If multiple values are reported for an intervention or event topic variable (i.e., for variables --TRT or --TERM), the applicant will split the values into multiple records or otherwise resolve the multiplicity per the applicant's data management procedures. For example, if an adverse event term of "Headache and nausea" is reported, sponsors will often split the original report into separate records and/or query the site for clarification. | | 1 | Prespecified interventions and events (--PRESP, --OCCUR, --STAT, REASND) | Product Impact on Individual Health Only: Interventions (e.g., concomitant medications) and events (e.g., medical history) can be collected as responses to a prespecified list of treatments or terms. In such cases: - --PRESP represents when topic variable values, specific interventions (--TRT) or events (–TERM), were prespecified at the time of data collection. Values will be "Y" (for "Yes") or a null value.
- --OCCUR represents whether prespecified interventions or events occurred or did not occur. Values will be populated for prespecified interventions and events only populated will be "Y" and "N" (for "Yes" and "No"). When an intervention or event is not prespecified, the value of --OCCUR will be null.
- --STAT and --REASND can be used to provide information about prespecified interventions and events for which there is no response (e.g., investigator forgot to ask). In such cases the value of --STAT will be "NOT DONE" and the value of --REASND will be the reason when collected.
The following table shows the population of --PRESP, --OCCUR, --STAT, and --REASND for different data collection scenarios. | Collection Scenario | --PRESP Value | --OCCUR Value | --STAT Value | --REASND Value |
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| An intervention or event was prespecified at the time of collection and occurred. | Y | Y |
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| | An intervention or event was prespecified at the time of collection and did not occur. | Y | N |
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| | An intervention or event was prespecified at the time of collection with no response and no reason collected. | Y |
| NOT DONE |
| | An intervention or event was prespecified at the time of collection with no response and reason collected. | Y |
| NOT DONE | Forgot to ask. | | A spontaneously reported intervention or event was collected. |
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