Vernaglia, Chmielewski, Faget Co-Author New Edition of Clinical Research Compliance Manual

Partners Larry Vernaglia and Monica Chmielewski and Special Counsel Kyle Faget have co-authored a new edition of the “Clinical Research Compliance Manual: An Administrative Guide.”

The new edition, its third, is essential reading for anyone receiving or applying for clinical research funding. It covers some of today’s most crucial topics, including human subject protections, Institutional Review Board regulations and requirements, conflicts of interest, and more.

The manual has been updated to include among other things a discussion of the revised Common Rule, an analysis of enforcement under the European Union’s 2018 General Data Protection Regulation, and new information about HHS’s updated informed consent in human subject research regulations, commonly known as the “2018 Rules.”

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