The Mechanics of Clinical Trial Agreements

Date: Sunday, Oct. 12 Time: 8:00 am – 12 noon Location: The Alexis Park Resort Hotel, 375 East Harmon Avenue, Las Vegas, NV Advanced Registration Deadline: Sept. 30 Online Registration Deadline (with $150 late fee): Oct. 7 Contact Hours: 3 Member Price: $299 Non-Member Price: $449 Hotel Information Call (800) 582-2228 for hotel reservations, mention attending ACRP 2008 Workshop Weekend, and get a discounted hotel rate of $129/night. These rooms are available on a first-come first-served basis. Discounted rates are not available after September 15. If you don't want to register online, please use this printable registration form.

During this workshop we will analyze a typical clinical trial agreement and address the financial, clinical, ethical, regulatory and legal issues from a fiscal, clinical and regulatory perspective.

We’ll review the requirements of HIPAA authorization and consent representations and warranties, indemnification clauses and governing law clauses.

Learning Objectives

Upon completion of this program, attendees should be able to:

• Identify the key structural components of a compliant clinical trial agreement.
  
  
• Negotiate the terms of a clinical trial agreement with consideration of regulatory objectives.
  
  
• Spot problem areas or issues that need special attention.

Trainers

Janice A. Anderson, BSN, JD is a partner in Foley's Health Care Industry Team with 25 years' experience focusing on health regulatory and compliance issues and over 30 years' experience working in the health care industry. Ms. Anderson is a participating member of Foley's Business & Transactions, Payments, Compliance & Government Programs, Regulatory & Strategic Counseling and Medical Devices Focus Groups as well as a participant in a working group dealing with Medicare Reimbursement. She serves on the governing council of the Health Law Section of the State Bar of Michigan; is a member of the Michigan Health & Hospital Association's Quality, Compliance & Patient Safety Committee; and is a member of the American Bar Association as well as the American Health Lawyers Association (AHLA).

Anne Cooper is an associate with Foley & Lardner. She is a member of the firm's Health Care Industry Team. Ms. Cooper advises clients on anti-kickback, Stark, Medicare, and other regulatory issues relating to business agreements. She once counseled clients on financial requirements and health care representation for a loan agreement to purchase twelve nursing facilities. She has also assisted health care entities with federal and state law compliance issues including managing fraud and abuse risks in various hospital business activities. Ms. Cooper is a member of the Illinois Bar, the Missouri Bar, the Washington D.C. Bar, the American Bar Association and the American Health Lawyers Association.

Ms. Cooper has been involved with the Junior League of Washington and Community Tax Aid, Inc. in Washington, D.C., the Saint Louis Tax Assistance Program, the Saint Louis Race for the Cure, and the Junior League of Saint Louis. Prior to joining Foley, she was employed with various health care institutions. In addition, while acting as a faculty fellow at Saint Louis University, she performed research for the bioethics textbook, "The Ethics and Regulation of Research with Human Subjects."

Ms. Cooper received her bachelor's degree from Rhodes College in 1993. She earned her J.D. degree from the Saint Louis University School of Law in 2004 where she was also lead articles editor of the Journal of Health Law.

Accreditation Council on Continuing Medical Education The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The ACRP designates this educational activity for a maximum of 3.0 AMA PRA Category 1 credits.™ Each physician should only claim credit commensurate with the extent of their participation in the activity.  (Program Number 0007229-08-CME-434) Association of Clinical Research Professionals The Association of Clinical Research Professionals (ACRP) provides 3.0 continuing education credits for the completion of this educational activity with the completion of the evaluation form.  Only claim those credits that are actually earned. These credits can be used to meet the certification maintenance requirement. (Program Number ACRP-2008-ACE-434) Continuing Pharmacy Education The Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Number 234-000-08-124-L04-P has been assigned to this program. This program provides 3.0 contact hours of continuing education credit. A statement of credit will be available upon completion of the workshop. Each participant must submit a completed evaluation form at the end of the program to receive a Continuing Education Statement of credit. Partial credit will not be awarded. Release date: 10/12/2008. Continuing Nursing Education The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. This workshop provides 3.0 contact hours of continuing nursing education credit (Program Number 11147-2008-ACE-124).