Contract Language for Clinical
Research Agreements
Between Academic Medical Centers and Industry Sponsors
Contact Us
CCGE
Duke Clinical Research Institute
PO Box 17969
Durham, NC 27715
E-mail: damon.seils@duke.edu
Background Reading
Sponsorship, authorship, and accountability.
N Engl J Med. 2001; 345:825-827.
Clinical-trial agreements between medical schools and industry. N Engl J Med. 2003; 348: 476-478.
Scope and impact of financial conflicts of interest in biomedical research. JAMA. 2003; 289: 454-469.
Gag clauses in clinical trial agreements. N Engl J Med. 2005; 352: 2160-2162.
Other Resources
The CLINRES-L
list is an e-mail listserv for the Academic Health Centers Clinical Research
Working Group.
The Association of American Medical Colleges has a Task Force on Financial Conflicts of Interest in Clinical Research.
The current draft of the agreement was revised on May 16, 2003.
Download the agreement in Microsoft Word format by clicking here.
We have drafted contractual language for a proposed standard clinical research agreement between academic medical centers and industry sponsors. The proposed language is meant for use in site-level agreements in multicenter clinical trials. As the language is revised, new drafts will be made available for download at this site. Please direct your comments, questions, and suggestions to Damon Seils at damon.seils@duke.edu.
CURRENT STATUS
As of May 16, 2003, the agreement has been approved by Duke University
Counsel, both for use when Duke is a site in a multicenter, commercially
sponsored clinical trial, and for the Duke Clinical Research Institute
to distribute to sites for the trials it manages.
The agreement is provided as a model site agreement, applicable to academic institutions and participating investigators that conduct multicenter clinical research studies which involve human subjects. We hope that this template will stimulate discussion in furtherance of the implementation of the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" issued by the International Committee of Medical Journal Editors (ICMJE) with regard to investigators' participation in study design, access to data, and control over publications in the conduct of clinical research.
SECTION NOTES
Links to annotations of relevant sections of the
agreement are placed here as they become available:
1. Statement of Work
2. Conformance with Law...
3. Period of Performance
4. Cost and Payment
5. Participating Investigator
6. Independent Contractor
7. Independent Research
8. Recordkeeping and Reporting
9. Confidential Information
10. Publicity
11. Governance of the Study
13. Biological Materials
14. Publications
15. Inventions and Patents
16. Indemnification...
17. Debarment Certification
18. Termination
19. Entire Agreement and Changes
20. Assignment
21. Notices
CONTRIBUTORS
Duke University Medical Center
Nina L. Cannon, JD
Marion W. Jervay, JD
Michael P. Redden, JD
Kevin A. Schulman, MD
Damon M. Seils
H. Gilbert Smith, PhD