Clinical Events

The CDASHIG CE domain includes clinical events of interest that would not be classified as adverse events. Events included in the CE dataset should be consistent with protocol requirements. Clinical events may be captured either as free text or via a pre-specified list of terms. The structure of the CE domain is 1 record per clinical event per subject. It is the sponsor's responsibility to define a clinical event, and the event 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 clinical events.