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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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Is IRB review required when linking to clinicaltrials.gov postings on patient advocacy websites and newsletters?
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Is parental consent required for research involving children?
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Do parents need to accompany adolescents at each research-related office visit?
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