Harmonization of Clinical Study Agreements Initiative
Collaboration between academic institutions and pharmaceutical and/or device companies is important as a means of facilitating co-operative research and advancing science. CAHO seeks to foster such collaborations. A key aspect of any such collaboration is the contract between the parties, which defines the relevant ethical, financial and academic issues. Engaging in the negotiations to develop a contract can be challenging since each institution and each company often appear to have unique needs; however, on closer inspection, there are common principles that underlie all such contracts.
In recognizing the potential benefits that would accrue from harmonization across multiple institutions, a CAHO Steering Committee was formed to draft working principles for consideration when academic institutions negotiate with industry. The result of this work was the creation of a document entitled Statement of Principles to be Considered When Negotiating a Clinical Study Agreement (Statement of Principles), the inaugural version of which was released in September 2007. The Statement of Principles set out the recommended minimum standard requirements for Ontario academic hospitals when negotiating a clinical study agreement.
At that time, the Steering Committee decided that it should become a “living document” that evolves with time to address the needs of academic institutions and our research partners in the pharmaceutical and devices industries. Over the last two years, the Statement of Principles has been utilized by a range of industry and academic organizations, and we have received positive feedback on its value in expediting the negotiation of clinical study agreements. We have also received a number of suggestions for improving the document.
With this in mind, the Steering Committee solicited feedback from stakeholders through a consultation process in late 2009 and has now updated the Statement of Principles in light of the feedback received. You will find Version 2.0 of the Statement of Principles through the link posted below.
Academic hospitals, pharmaceutical companies and contract research organizations are encouraged to use this document as a basis for drafting contract templates and carrying out negotiations. This initiative has been presented at various conferences. The slides are available through the links below.
Should you have any feedback, or if you would like to be added to a mailing list to receive updates regarding the Harmonization of Clinical Study Agreements Initiative, please forward your comments to the Council of Academic Hospitals of Ontario, at info@caho-hospitals.com.
Statement of Principles for Negotiating a Clinical Studies Agreement Version 2.0
Conference Presentations
Past Conferences:
OHA Videoconference on the Clinical Study Agreement Initiative
Toronto, September 09, 2008 Presented by Michelle Moldofsky, Karen Arts, and Art Slutsky
CAHO Conference on the Clinical Study Agreement Initiative
Toronto, February 22, 2008 Presented by Michelle Moldofsky and Karen Arts
Insight Conference October 2, 2007 Presented by Laurel Evans
MAGI Clinical Trial Agreements and Budgets Conference San Diego, October 1, 2007 Presented by Michelle Moldofsky and Karen Arts
CAURA National Conference Montreal, May 7, 2007 Presented by Michelle Moldofsky, Karen Arts, and Laurel Evans
Documents:
CAURA Presentation
Michelle Moldofsky and Karen Arts
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