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Description/Overview

Adverse Events (AE) represents 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 variables to the following collection metadata specification as Recall, that fields may be added from the CDASH Model, the SDTM, or created using guidance in the TIG to ensure data needed to meet scientific and regulatory requirements using guidance in Section x.x, How to Extend Metadata.are collected.  

Specification

Assumptions

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