Page History

...

Adverse Events (AE) represents 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 characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. 

...