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Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
What is a Clinical Trial?
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.1
Who at ORSP can help me process my Clinical Trial Routing Form?
Your first point-of-contact should be your department research administrator (RA). If you are not sure who that is, you can find your department RA in the Blue Pages.
Next, be sure you understand how to use the Clinical Trial Routing Form (CTRF) in eResearch.
I have a particular physical condition or medical situation. How can I participate in a clinical trial?
Visit https://umclinicalstudies.org/ to learn more about Clinical Trial Studies and participation opportunities.
I've heard about the Accelerated Clinial Trial Agreement (ACTA). How can I learn more about this for use by my research project team?
University of Michigan Supports Adoption of Accelerated Clinical Trial Agreement (ACTA). For those industry partners that agree to use the agreement (and the sponsor must agree to use it), it will decrease contract negotiation time. The other steps, such as budget negotiation, proposal approval form (PAF) processing, and IRB review and approval are still required. And U-M is committed to exploring process improvements and working toward the goal of reducing the total time to opening a clinical trial in all of these areas.
The ACTA is a straightforward and unambiguous document that clearly sets forth the contractual obligations of both parties, and presents language which — while perhaps not ideal for either party — is acceptable to both. Adoption and use of the ACTA will expedite the contract negotiation process and reduce the time it takes to start up industry-sponsored, multi-center clinical trials.
How to use this at U-M
We are ready and fully setup at U-M to support and encourage the use of the ACTA for industry sponsored multi-center clinical trials! Here is what you can do to take advantage:
- There is a new question in the eResearch Proposal Management System (eRPM) for the PI added to the "Sign UFA" activity where you may indicate that you would like to attempt the use of the ACTA during the UFA process.
- Answering “Yes” allows ORSP to approach the sponsor to propose the use of the ACTA.
- Additionally, on the Clinical Trials Routing Form (CTRF), the UFA answer will carry over from the NDA. If not answered, ORSP project representatives can help you later pursue the ACTA.
- Project Award Notices (PANs) will also carry language to indicate if the ACTA was accepted.
- Contact one of the following ORSP PRs directly when you have questions, if a Sponsor indicates an interest in using the ACTA, or if a Sponsor would like a template agreement to review.
You can review the language in the agreement from the ACTA Website. The ACTA is not the promise of a full solution to industry-initiated clinical trial contracting, but it can help reduce one part of the process.
(1) U-M has adopted NIH's definition of clinical trials to track and monitor organizational metrics. See full NIH definition with detailed footnotes.