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Description
An Events general observation class domain used for data describing untoward medical occurrences in subjects which may or may not have a causal relationship with the product. Events represented in the AE domain will be consistent with scientific and regulatory requirements. It is the applicant's responsibility to define an event and the appropriate collection period for events. This definition may vary based on product characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection.
It is assumed that applicants will add collection fields to the following metadata specification as needed to meet scientific and regulatory requirements.
Specification
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Assumptions
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Overview
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