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Canada pilots model clinical trial agreement

Clinical News | October 04, 2011


Peter Mansell

Canada pilots model clinical trial agreement

The Canadian Institutes of Health Research (CIHR) is piloting a model Clinical Trial Template Agreement (mCTA) in an effort to simplify and expedite negotiations between sponsors, trial sites and principal investigators for Phase II and III single and multisite studies.

The CIHR is inviting all members of the Association of Canadian Academic Healthcare Organizations (ACAHO) and the national association for research-based pharmaceutical companies, Rx&D – which worked together on drafting the model agreement – to take part in the six-month pilot, which runs from 1 October 2011 to 31 March 2012.

Members are asked to use the mCTA during this period as the basis for negotiating agreements on regular Phase II and Phase III trials.

“You can of course modify the mCTA for the purposes of the actual agreement that you sign, however, we would ask that you limit changes to only what is absolutely necessary, and note these items in the attached forms that we will then ask you to return to CIHR,” the three stakeholder organisations comment in a letter to colleagues.

Expediting start-up times for clinical studies will “bring us one step closer towards increasing the attractiveness of Canadian clinical trial sites as preferred partners internationally for clinical trials, and ultimately continue to bring human, social and economic benefits to all”, CIHR, Rx&D and ACAHO stated.

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