2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC33
Submitter : Ms. Judy Matuk Date & Time: 05/02/2005 05:05:32
Organization : SUNY Human Subjects Forum
Category : Academia
Issue Areas/Comments
GENERAL
GENERAL
From an IRB member/administrator perspective, the expectation of an IRB's ability to assess a change in the risk/benefit ratio when reviewing the multitudes of off-site SAEs required for submission under the current system is unrealistic. The inundation of paperwork resulting from the current FDA requirement does not permit effective assessment of a 'signal' event amidst all the submitted 'noise'. It is recommended that, for off-site events, it should be the responsibility of independent safety monitoring boards set up by the sponsor to filter this information. IRB's should only receive off-site SAE's that require a change in protocol, change in the informed consent process, or any information which suggests a changes in the risk vs. benefit balance. Annual reports on overall SAE findings should be prepared and submitted to local investigators for submission to their IRB.