FDA has issued final guidance concerning the transfer of clinical studies between IRBs. According to Zachary Brennan on www.outsourcing-pharma.com, FDA says the transfer process “should be accomplished in a way that assures continuous IRB oversight with no lapse in either IRB approval or the protection of human subjects, and with minimal disruption of research activities.” The guidance suggests documenting this process in a written agreement, outlining all studies, protocols, and IRB records associated with the transfer study. It also provides reference to the regulatory responsibilities of IRBs, clinical investigators, and sponsors while transferring a clinical study from one IRB to another.
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