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Description/Overview

The CDASHIG Adverse Events (AE) domain includes clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to 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 sponsor's responsibility to define an event. This definition may vary based on the sponsor's requirements for characterizing and reporting product safety and is usually described in the protocol.

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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