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1. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards


2. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)


3. OHRP generally conducted its compliance activities independently, but changes would strengthen its independence


4. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff