Model Clinical Trial Template Agreement (mCTA)
For pilot participants registered prior to February 15, 2012, and who may have downloaded the earlier version, please note that this version of the mCTA has additions in red in Section 5. These changes were intended to have been included in the original mCTA to help both clinical trial sites and sponsors reflect a principle investigator perspective. They are strongly recommended; however, as with all provisions in the template, parties who use the mCTA during the pilot period are able to tailor its provisions to their own specific situations. Changes made in the course of each negotiation should be reported back to CIHR on the "Joint Record of Changes to the mCTA" form [ RTF (1 MB) ].
This model Clinical Trial template agreement (mCTA) is being provided primarily for members of ACAHO (or those who negotiate clinical trial agreements on their behalf) and Rx&D for pilot test purposes between October 1, 2011 and March 31, 2012.
Feedback is also welcomed from all other stakeholders. The primary objective is to provide a standard model contract for use by clinical trial sites and sponsors in negotiating phase II and phase III clinical trial agreements.
The mCTA was proposed jointly by representatives of both ACAHO and Rx&D who worked with legal counsel, through funding provided by CIHR. The mCTA is a direct response to recommendations from the field for a standard clinical trial template agreement that can help to streamline the negotiating process and expedite clinical trial start up times.
During the pilot period, the mCTA is intended to be used as the basis of regular Phase II and III clinical trial agreement negotiations between clinical sites, sponsors, and principal investigators. If changes are necessary, the signatories may modify the agreement to suit their organization's/partner's needs. However, participants are asked to keep changes to a minimum and are asked to record any changes on the feedback form that will be provided by CIHR. These forms will allow us to understand how to specifically modify the agreement in order to achieve acceptability to the broadest possible cross-section of stakeholders.
At the end of the pilot period, all participants will also have the opportunity to provide a higher level and more qualitative or experiential review of the mCTA. The information from this assessment will also be used to finalize the template for going forward.
For stakeholders willing to provide feedback who are involved in contract negotiations but are not members of Rx&D or ACAHO, or who are not directly involved in contract negotiations
Comments or feedback from all other stakeholders is encouraged and welcomed. You may review the mCTA by accessing it below, and can provide feedback via letter to CIHR at email@example.com. The feedback will be reviewed and assessed qualitatively by CIHR, ACAHO, and Rx&D.
- Presidents' mCTA announcement letter
- Model Clinical Trial Template Agreement (updated February 15, 2012)
- Pilot Participants
- Instructions for the Pilot
- mCTA Feedback Forms
- mCTA News
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