Clinical Research Law
and Compliance Handbook John E. Steiner, Jr., Esq.,
Chief Compliance Officer, The Cleveland Clinic Foundation
Softbound: 460 pages
ISBN 0763747254
9780763747251
Jones & Bartlett
Copyright 2006 (click button below for the very best currently available price
for this important resource)
Avoid the hazards of legal and regulatory
noncompliance in your clinical research programs.
As clinical research breakthroughs, as well as
mishaps, continue to make headlines and regulatory oversight
increases, compliance issues continue to mount.
Written in clear, practical language, the
Clinical Research Law and Compliance Handbook will help you
navigate the clinical research maze as it addresses critically
important legal, operational, ethical, and business issues
associated with clinical research trials. Written by leading experts
in the field, this timely and comprehensive resource provides easy
access and clear guidance for your clinical research questions and
concerns. Key features of this book include:
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.
Edited by John E. Steiner, Jr., Esq.,
chief compliance officer and privacy official for the Cleveland
Clinic Health System.
Contributed articles include:
Key Compliance Issues for Academic
Medical Centers -- Joan Booth, RN and Katherine Hammerhofer, RN,
both of The Cleveland Clinic Foundation
Contract Issues in Domestic Clinical
Trials -- Donna J. Meyer, Esq., The Cleveland Clinic Foundation
Clinical Research Billing: Process and
Monitoring Issues -- John E. Steiner, Jr., Esq., The Cleveland
Clinic Foundation, and F. Lisa Murtha, JD, Parente Randolph, LLC
Clinical Research Trials: Operational and
Budget Issues -- William A. Hunt and Sue O’Connell, both of Medcom Solutions, Inc.
Fraud & Abuse in Clinical Research --
Karen Owen Dunlop, Esq. and William A. Sarraille, Esq., both of
Sidley, Austin, Brown & Wood
Identifiable Health Information in
Clinical Research: National and International Issues -- M. Peter
Adler, Esq., Foley & Lardner, and Jeffrey G. Micklos, Esq.,
Federation of American Hospitals
Issues in Non-Registrational,
Post-Marketing Studies -- Judith E. Beach, PhD, Esq. and Nancy Strehlow, Esq., both of Quintiles Transnational Corp.
Key Compliance Issues for Institutional
Review Boards -- Michael J. Meehan, Esq. and Marleina Thomas
Davis, Esq., both of The Cleveland Clinic Foundation
Conflicts of Interest in Clinical
Research -- Kendra Dimond, Esq. and Joseph B. Clamon, Esq., both
of Epstein, Becker & Green
Data Integrity and Patient Safety in
Clinical Trials -- Jeffrey Green, PhD, and Marc Shlaes, both of
DataTrak International, Inc.
Legal Issues in the Conduct of
Multinational Clinical Trials by U.S. Entities -- Jan E. Murray,
Esq.,
Squire, Sanders & Dempsey, L.L.P.
Clinical Trials in the Courtroom --
Andrew Agati, Esq., Squire, Sanders & Dempsey, L.L.P.
John E. Steiner, Jr., Esq. is chief compliance
officer and privacy official for the Cleveland Clinic Health System.
He is responsible for the design, implementation and administration
of the compliance programs for a multi-state, integrated delivery
system that includes an academic medical center. The compliance
programs include requirements of government and private payors,
clinical research, and HIPAA. Steiner previously served as Senior
Counsel for the American Hospital Association in Chicago where he
led the effort on behalf of the hospital industry to create, in
conjunction with the Office of Inspector General of the Department
of Health and Human Services model voluntary compliance guidelines
for hospitals. As Senior Counsel, he also addressed healthcare legal
issues for 5,000 member hospitals and general corporate issues for
the association and its subsidiaries. He also previously served as a
member of the health law department of a national law firm
headquartered in Chicago, Illinois. Steiner is a board member of the
Health Care Compliance Association, the Chairman of the Council of
Compliance Officers of the American Group Practice Association, a
frequent speaker at national health law and compliance conferences,
and has published numerous articles and books on health law and
compliance topics.
