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

21 November 2019 Media Contact: Jill Chanen News
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.”

For more information about or to purchase the book, click here.

Related Services


Bad Holiday Season News! Estimates of an increase of Cyberattacks 20%!
13 December 2019
Internet, IT & e-Discovery Blog
Driving the Future of Automotive Technology
12 December 2019
Manufacturing Industry Advisor
Massachusetts Governor Proposes Facility Fee Ban
12 December 2019
Health Care Law Today
American Rule Prevails; PTO May Not Collect In-House Attorneys' Fees as "Expenses"
12 December 2019
IP Litigation Current
ACCC 46th Annual Meeting & Cancer Center Business Summit
04-05 March 2020
Washington, D.C.
Foley/Deloitte Compliance and Privacy Officer Roundtable
27 February 2020
Boston, MA
Let’s Talk Compliance
24 January 2020
Orlando, FL
New England Alliance Annual Meeting
15-17 January 2020
Woodstock, VT