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Differences in OHRP, FDA and ICH Regulations/Guidelines

Differences in OHRP, FDA and ICH Regulations/Guidelines. Monika Haugstetter, MHA, MSN, RN Human Subject Protection Office (HSPO) and Institutional Review Board (IRB), UCHC September 2010. Outline . Agencies Applicable Regulations/Guidelines Scope Definition of Research

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Differences in OHRP, FDA and ICH Regulations/Guidelines