Harmonization of Clinical Study Agreements Initiative

Feedback Request: Statement of Principles to be Considered When Negotiating a Clinical Study Agreement Version 2.0

Dear Colleagues,

On behalf of the Clinical Studies Agreement (CSA) Steering Committee at the Council of Academic Hospitals of Ontario (CAHO), I am pleased to share with you a draft copy of Version 2.0 of the "Statement of Principles to be Considered When Negotiating a Clinical Study Agreement” (Statement of Principles). In September 2007, CAHO released the inaugural version of this document. At that time, the committee decided that the Principles document should become a “living document” that evolves (and hopefully improves) 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.

In August 2009, the CSA Steering Committee met and updated the Statement of Principles in light of the feedback we received. Enclosed you will find a draft copy of Version 2.0 with all of the changes tracked in the document for ease of identification. The Steering Committee is hoping to get broad input on this document. We welcome your comments on all the proposed revisions, as well as any additional suggestions that you may have. Please submit your feedback to CAHO at info@caho-hospitals.com by October 1, 2009.

Following receipt and review of comments, the CSA Steering Committee will release Version 2.0 of the Statement of Principles in Fall 2009.

We look forward to hearing from you.

Arthur Slutsky, MD
Chair, Clinical Studies Agreement Steering Committee
Council of Academic Hospitals of Ontario

Principles Document

Statement of Principles for Negotiating a Clinical Studies Agreement - Version 2.0

Background

Background and Archived Materials