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It’s a rare occurrence, but each year some institutions are subjected to a for-cause audit by the Office for Human Research Protections (OHRP). Such audits often turn up documentation problems and review process problems with the IRB, but occasionally they also highlight very serious problems relating to the clinical trials management, such as failure to provide adequate informed consent or failure to seek an IRB review, according to OHRP officials.

No need to panic when OHRP comes a calling