In an effort to expedite the process of study start-up, the Office of Industry Contracting is implementing its ACTA Program, available to our investigators starting April 3rd, 2017. As a part of this program, the University has adopted the Accelerated Clinical Trial Agreement (the "ACTA") template as an option for use in all of our industry-sponsored clinical studies.
The ACTA Program will utilize the ACTA template, which was selected because of its balanced and uniform approach to contracting. Developed through an NIH grant, the ACTA is a standardized template created with input from industry sponsors, universities, and health care organizations. UNC Chapel Hill served on the group that drafted and edited the ACTA agreement, and it has been adopted by 113 organizations. The ACTA clearly delineates the roles and responsibilities of both the industry sponsor and the study site and provides mutually-acceptable compromises on important contractual issues such as publication, subject injury, and indemnification.