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Good Communication Can Minimize Disruptions During IRB Transfers
To smoothly transition clinical investigation oversight from one IRB to another, new and old IRBs, clinical investigators, sponsors and CROs should work closely to minimize disruptions to the ongoing trial and ensure subjects are constantly protected, according to a new draft guidance. The involved parties will also need to keep the FDA abreast of any changes to the study’s oversight, the June 12 guidance states.
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