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.
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. This resultant principles document sets out the recommended minimum standard requirements for Ontario academic hospitals when negotiating a clinical study agreement.
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 on this site to provide background and transparency of our process.
Recognizing the evolving nature of the clinical trial agreements environment, this is a “living document” and as such will be periodically reviewed and revised as appropriate. The CAHO Steering Committee welcomes feedback, especially with regard to usability and variation of interpretation.
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 Brendon Rell at the Council of Academic Hospitals of Ontario, at brell@caho-hospitals.com.
Statement of Principles for Negotiating a Clinical Studies Agreement
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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