Instructions for the Model Clinical Trial Template Agreement (mCTA) Pilot

If an organization is participating in the pilot program

1. Ensure that the relevant individual(s) at the organization are apprised of the pilot program initiative, its goals, and the organization's participation.
2. Send an email to CIHR at mcta-meec@cihr-irsc.gc.ca to advise that the organization is a participant. CIHR will publicly recognize the member organizations of ACAHO and Rx&D which are participating in the pilot program on the CIHR website, and will provide them with the pilot feedback forms. These forms will also be available electronically on the CIHR website.

How the pilot works

3. Participating organizations will work as they normally would on contract agreements between the clinical trial sponsor and the trial site to agree on the terms of the contract; however, pilot participants must use the mCTA template as the basis of the negotiation.
4. Modifications to the agreement that are deemed essential by the trial site and the sponsor are made directly into the template agreement. The mCTA template is available on the website as a Word document which can be downloaded and modified to become the actual clinical trial contract.
5. Note any modifications and the rationale for these changes on the supplied feedback form, "Joint Record of Changes to the model Clinical Trial Agreement" [ RTF (1 MB) ]. One form should be completed jointly by the site and sponsor for each contract negotiated during the pilot period.
6. Email the feedback form back to CIHR at mcta-meec@cihr-irsc.gc.ca after each completed clinical trial contract negotiation.
7. At the end of the pilot period, all participating organizations will also be asked to provide an overall assessment of the mCTA experience in another short questionnaire. This final questionnaire will be completed individually by each clinical trial site and industry sponsor participating in the pilot program, and should be returned by e-mail to CIHR at mcta-meec@cihr-irsc.gc.ca.

Organizations or interested individuals not participating in the pilot program but wishing to provide feedback on the mCTA template may send their comments in writing to CIHR at mcta-meec@cihr-irsc.gc.ca.