Clinical Trial Agreements Toolkit

Published on March 10, 2016

Toolkit Overview:

The Academic Medical Centers and Teaching Hospitals; Life Sciences; and Regulation, Accreditation, and Payment Practice Groups are proud to present the Clinical Trial Agreements (CTA) Toolkit.

The CTA Toolkit is designed to assist health lawyers with understanding and negotiating clinical trial agreements between industry sponsors and academic medical centers in instances where the industry party is the sponsor of a study involving an investigational drug. The CTA Toolkit is divided into 17 sections that represent key provisions of a CTA and is designed to provide the ideal provisions from both the industry-sponsor and academic medical center-clinical trial site perspective, as well as the reasoning behind those positions. The Toolkit also provides an overview of the business importance of each of these sections; relevant federal, state, or local laws; case law; international laws; other directives and resources; and operational considerations.

Toolkit Contents:

Complete Toolkit

Clinical Trial Agreements Toolkit

• Includes all sections.

Sections

List of Defined Terms

1. Conduct of Study, Protocol Deviations, and Duties of Site and Investigator
2. Representatives and Warranties
3. Monitoring, Auditing, Inspection
4. Compensation and Open Payments
5. Confidentiality
6. Privacy and Security
7. Data Ownership and Use
8. Record Retention
9. Publication
10. Intellectual Property
11. Biospecimens
12. Indemnification
13. Insurance
14. Subject Injury
15. Debarment
16. Assignment
17. Term and Termination

Toolkit Authors and Editors:

We would like to acknowledge the contributions of the following individuals in the production of this Toolkit:

Editors:

Jessica M. Baker (SUNY Buffalo, Buffalo, NY)
Lindsey Johnson (The Children's Hospital of Philadelphia, Philadelphia, PA)
Sheea Sybblis (Bristol-Meyers Squibb, New York, NY)
Karen Mullin (The Forsyth Institute, Cambridge, MA)
Gelvina Rodriguez Stevenson (The Children's Hospital of Philadelphia, Philadelphia, PA)

Authors:

Andrea B. Anantharam (Hall Render Killian Heath & Lyman PC, Troy, MI)
Maureen Bennett (Jones Day, Boston, MA and San Francisco, CA)
Gina Brown (The Children's Mercy Hospital, Kansas City, MO)
Rachel H. Bryers (Quarles & Brady LLP, Milwaukee, WI)
Lianne Cleary (The University of Vermont Medical Center, Burlington, VT)
Jack M. Cook (Quarles & Brady LLP, Milwaukee, WI)
Marco DiPrato (Stewart Bernstiel Rebar & Smith, Blue Bell, PA)
Dana Good (The Children's Mercy Hospital, Kansas City, MO)
Carrie A. Hanger (Smith Moore Leatherwood LLP, Greensboro, NC)
Kristina Harr (The Children's Hospital of Philadelphia, Philadelphia, PA)
Molly G. Huggins (Huggins & Zuiker LLP, Savannah, GA)
Melissa L. Markey (Hall Render Killian Heath & Lyman PC, Troy, MI)
Mark A. McAndrew (Taft Stettinius & Hollister LLP, Cincinnati, OH)
Joe Morahan (Clintrax Global Inc., Raleigh, NC)
Karen A. Mullin (The Forsyth Institute, Cambridge, MA)
Jan Murray (Foley & Lardner LLP, Boston, MA)
Helene Orescan (UCLA School of Medicine, Los Angeles, CA)
Liza M. Roe (Hall Render Killian Heath & Lyman PC, Troy, MI)
Andrew P. Rusczek (Verrill Dana LLP, Boston, MA)
Marylana Saadeh Helou (Verrill Dana LLP, Boston, MA)
Priya Sankar (Incyte Corporation, Philadelphia, PA)
Tom Schrak (Hall Render Killian Heath & Lyman PC, Indianapolis, IN)
Tara Scrogin (University of Nebraska Medical Center, Omaha, NE)
Gelvina Rodriguez Stevenson (The Children's Hospital of Philadelphia, Philadelphia, PA)
Leslie M. Tector (Quarles & Brady LLP, Milwaukee, WI)
Leah Voight (Spectrum Health, Grand Rapids, MI)
Judy Zybach (Evergreen Health, Kirkland, WA)