Accelerated Research Agreements (ACDA and ACTA)
In an effort to streamline the negotiation of nondisclosure agreements and clinical trial contracts and to reduce the time that it takes to initiate clinical trials at the University of Louisville (UofL), the University of Louisville Research Foundation, Inc. (ULRF) has agreed to the use of the Accelerated Confidential Disclosure Agreement (ACDA) and to use the terms of the Accelerated Clinical Trial Agreement (ACTA) for industry-sponsored, multi-center clinical trials. These accelerated research agreements were developed by 25 Clinical & Translational Science Award (CTSA) recipients in collaboration with industry sponsors and the University Industry Demonstration Partnership (UIDP). UofL participated in the UIDP Clinical Trials Work Group that contributed to the ACDA and the ACTA.
Use of the ACTA in the UofL Clinical Trials Environment
UofL researchers often perform clinical trials at one or more third party hospitals or facilities. Each of these facilities is affiliated with the University and permit research to be conducted on site by UofL researchers, but each is a separate legal entity. As such, these facilities typically require separate, direct agreements with the Sponsor of the clinical trial (e.g. a letter of indemnification (LOI) or a facility use agreement (FUA)). Therefore, for clinical trials that utilize third party facilities/services, the Sponsor may be required to establish a separate agreement with the respective facility in addition to the CTA with ULRF.
Clinical trials conducted in University of Louisville facilities (e.g. Clinical Trials Unit) that do not require the involvement of third parties should only require execution of the ACTA with ULRF.
For more information regarding the ACDA and ACTA, please visit the ARA4us web site.