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Titles
- E6(R2) good clinical practice: integrated addendum to ICH E6(R1)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 boards1
- Informed consent. Guidance for IRBs, clinical investigators, and sponsors1
- Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators1
- Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators1
- Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff1
- OHRP generally conducted its compliance activities independently, but changes would strengthen its independence1