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What are RCRC IRB’s reporting requirements for unanticipated problems involving risks to participants or others and other safety reports?

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What are RCRC IRB’s reporting requirements for unanticipated problems involving risks to participants or others and other safety reports?

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RCRC requires reporting of unanticipated problems (definition below) and other safety reports (definition below) within 10 business days of discovery or receipt from the sponsor.

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