The GUMC Office of the Dean for Research and the Office of Regulatory Affairs are pleased to announce the establishment of the IRB Committee on Adverse Events and Safety Monitoring (CAESM) to serve as an adjunct to committees of the university’s Institutional Review Board. The Committee will serve two general risk management functions.
The Committee will provide a professional and scientific capability for assessing and responding to adverse event (AE) reports filed through the IRB electronic reporting system. Each report will be assigned to a reviewer who will then determine and record what response, if any, is required. This will follow the current reporting practice except that a second level of review will be employed. The Committee will met periodically to assess ‘red flags’ such as unexpected or excessively frequent serious adverse events.
The Committee will provide a core for acting as or separately establishing a Data Safety Monitoring Board (DSMB). Generally, for large industry sponsored multi-center trials, the sponsor will assemble a DSMB as needed. A DSMB established by the sponsor of the study is sufficient when it is approved by the IRB. The CAESM can establish a DSM to monitor individual studies if, in view of the IRB, such monitoring is warranted. This, provides the IRB an additional option in the course of its approval process.
The Committee’s initial chair will be Sorell L. Schwartz, Ph.D., Professor Emeritus of Pharmacology, and a long-serving IRB member, chair and adverse event reviewer.