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Description/Overview

The CDASHIG Adverse Events (AE) domain includes clinical represents data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to occurrences subjects which may or may not have a causal relationship with this treatment" (ICH E2A; available at https://www.fda.gov/regulatory-information/). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pretreatment events related to trial conduct, not collecting events assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms. The structure of the SDTMIG AE domain is 1 record per adverse event per subject. It is the sponsorthe 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 the sponsor's requirements for characterizing characterization and reporting of product safety and is usually described in the protocol.. 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 needed to meet scientific and regulatory requirements per guidance in Section x.x, 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.

Specification

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