Clinical Research Law and Compliance Handbook

Edited by John E. Steiner, Jr., Esq., chief compliance officer and privacy official for the Cleveland Clinic Health System.

Clear, thorough coverage of the most significant risk areas including fraud and abuse, billing and conflicts of interest.

Concise case summaries with detailed examples of litigated matters.

Outstanding working tools include templates, checklists, forms and a complete model Master Research Agreement.

Every chapter is packed with practical examples, relevant legal and regulatory authorities, suggested action steps and keen insights that will contribute to your effective clinical research compliance.

Essential for those involved in academic research as well as clinical research in all settings.

Introduction
John E. Steiner, Jr., Esq., Editor

Chapter 1
Practical Legal and Compliance Issues in Clinical Trials
John Steiner, Esq, Editor
Joan Booth, Manager, Cardiovascular Research,
Katherine Hammerhofer, Director, Center for Clinical Trials, The Cleveland Clinic Foundation

Chapter 2
Contract Issues in Domestic Clinical Trials
Donna J. Meyer, Esq.
Associate Counsel, Office of the General Counsel The Cleveland Clinic Foundation

Chapter 3
Clinical Research Billing: Process and Monitoring Issues
John E. Steiner, Jr., Esq.
Chief Compliance Officer and Privacy Official, The Cleveland Clinic Foundation
F. Lisa Murtha, JD, CHC
Principal, Parente Randolph, LLC

Chapter 4
Clinical Research Trials: Operational and Budget Issues
Bill Hunt
MedCom Solutions, Inc.
Sue O’Connell
MedCom Solutions, Inc.

Chapter 5
Fraud & Abuse in Clinical Research
Karen Owen Dunlop, Esq. and William A. Sarraille, Esq.
Sidley, Austin, Brown & Wood

Chapter 6
Uses and Disclosures of Identifiable Information in Clinical Research:  National and International Considerations
M. Peter Adler, Esq.
Foley & Lardner
Jeffrey G. Micklos, Esq.
Federation of American Hospitals

Chapter 7
Identifying Applicable Laws and Reducing Key Risks in Non-Registrational Post-marketing Studies 
Judith E. Beach, Ph.D., Esq.
Vice President and Senior Associate General Counsel, Regulatory and Government Affairs
Nancy Strehlow, Esq.
Special Counsel for Health Law and Policy, Quintiles Transnational Corp.

Chapter 8
Key Compliance Issues for Institutional Review Boards 
Michael J. Meehan, Esq. and Marleina Thomas Davis, Esq.
The Cleveland Clinic Foundation

Chapter 9
Conflicts of Interest in Biomedical Research – Avoiding Bias
Kendra Dimond, Esq. and Joseph B. Clamon, Esq., both of Epstein, Becker & Green

Chapter 10
Enhancing Data Quality and Patient Safety Through the Use of Technology in Clinical Trials
Jeffrey A. Green, Pharm.D., FCP
President & Chief Executive Officer, DATATRAK International, Inc., Cleveland, Ohio and Bonn, Germany
Marc Shlaes, B.S.
Vice President, Global Development, DATATRAK International, Inc., Cleveland, Ohio and Bonn, Germany

Chapter 11
Legal Issues in the Conduct of Multinational Clinical Trials by U.S. Entities
Jan E. Murray, Esq.
Squire, Sanders & Dempsey, L.L.P.

Chapter 12
Clinical Trials in the Courtroom
Andrew Agati, Esq.
Squire, Sanders & Dempsey, L.L.P.