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| 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.
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