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What are the IRB review requirements for human factors/usability testing?
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Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
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What questions can be asked when screening patients prior to them signing consent?
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When do I report a protocol deviation to the IRB? Do I need to report a summary of deviations at the time of continuing review?
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What documentation needs to be submitted to the IRB for an IND exemption request?
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Can you provide an IRB approval before FDA’s review of the IND?
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Does research involving retrospective review of patient charts require IRB review?
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How do EUAs for COVID-19 vaccines affect IBC oversight requirements for ongoing clinical trials?
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