Common use of Adverse Event Reporting Requirements Clause in Contracts

Adverse Event Reporting Requirements. The investigator is responsible for the detection and documentation of events meeting the criteria and definition of an adverse event (AE) or a serious adverse event (SAE), as provided in this protocol. Routine, adverse events of special interest (AESI), and expedited adverse event report forms and their supporting documentation must be submitted to DSSM according to the instructions in Sections 10.3, 10.4 and 10.6.