Skip to main content

SAE management

A serious adverse event (SAE) may happen in any clinical trial. Such occurrences must be recorded and reported to the FDA. Thus, the SAE forms are present in almost all studies maintained via the EDC application.

In the EDC application, the data is entered into the SAE forms under the DATA ENTRY tab, and the maintenance of the SAE forms, as well as SAE report tracking, can be managed with the STUDY INFO > SAE feature.

With EDC capabilities, you can perform the following actions in terms of SAE management:

In this section:

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.