EXCITING IMPROVEMENT to Clinical Trial Contracting Process at UK

Principal Investigators and Study Teams:

The Center for Clinical and Translational Science (CCTS) in conjunction with the Office of Sponsored Projects Administration (OSPA) is pleased to announce that we are now part of the CTSA initiative aiming to reduce clinical trial contracting delays.  The University of Kentucky is now registered as part of the CTSA consortium that is approved to utilize an Accelerated Clinical Trial Agreement (ACTA) for clinical trial contract negotiations.

What does this mean for investigators?

If the sponsoring agency is willing to accept a pre-approved template it will greatly speed up the clinical trial negotiation process.

How do you take advantage of the Accelerated Clinical Trial Agreement?

When you have a clinical trial contract that needs to be negotiated you will notify Dave Erem at OSPA  (dlerem2@uky.edu or 257-5993) that you have a clinical trial that you would like to use the ACTA. Dave and his staff will then contact the sponsoring agency and ask them to consider using the ACTA.  If the sponsor agrees this will cut down on the amount of time that it takes to finalize the clinical trial agreement. However, it is up to the sponsoring agency whether or not they will accept the ACTA for negotiations.

We hope this change will improve the facilitation of your clinical trials.

Kim C. Carter

Executive Director, Office of Sponsored Project Administration

Associate Director, University of Kentucky Research Foundation

Marietta Barton-Baxter, CCRC
Regulatory Program Director
Regulatory Knowledge and Support Core

University of Kentucky Center for Clinical and Translational Science (CCTS)