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.

The ACTA Program offers sponsors an option to bypass the traditional contract negotiation process with the University. In short, should sponsors agree to use the ACTA template, the University will commit to priority review and execution of the ACTA agreement within two business days, exclusive of IRB and budget approval. Participation in this program is voluntary for sponsors and investigators, and can change from study to study.

To take advantage of this program, investigators or their study staff should send an email to This email address is being protected from spambots. You need JavaScript enabled to view it. with the request, including the name of the sponsor and the protocol title. A contract manager will reply with a letter outlining the ACTA Program and the draft ACTA template for the sponsor's consideration. The letter will instruct the sponsor on next steps if they agree to participate in the ACTA Program.

The Office of Industry Contracting remains fully committed to expediting the contract negotiation process and increasing transparency in the study start-up process. Should you have any questions about this program, please contact Erin Edwards at This email address is being protected from spambots. You need JavaScript enabled to view it..

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