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Description
Findings About Events and Interventions (FA) is a domain is used to record findings related to events and interventions.
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Briefly, it represents collected data about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. For example, this may be the case when:
- The applicant collects information about pre-specified symptoms of event of interest on a daily basis.
- The applicant collects the occurrence of prespecified adverse events at every visit.
Specific criteria on when to use this domain, are provided in Section 2.8.4.
Specification
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Assumptions
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Overview
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