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Description/Overview

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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

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product characterization and reporting of product safety

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As with all the data collection variables recommended in CDASH, it is assumed that sponsors will add other data variables as needed to meet protocol-specific and other data collection requirements (e.g., therapeutic area-specific data elements and others as required per protocol, business practice or operating procedures). Sponsors should define the appropriate collection period for adverse events.

. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. 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 are collected.  

Specification

Assumptions

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