About the ACTA Program for Clinical Trials

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 ACTAProgram@unc.edu 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 Dana Gatz at dana_gatz@unc.edu.

ACTA FAQ for Investigators

  1. Is this program mandatory?

No, participation in the ACTA program is not mandatory and is completely up to the discretion of the investigator and the acceptance of the Sponsor.

  1. By participating in this program, will I be bound by the terms of the ACTA in future studies?

No. You can decide whether or not you want to participate in the ACTA Program for each study.

  1. Is the ACTA appropriate for all projects?

No, the ACTA is not appropriate for all studies. The ACTA was designed to serve as a contract for industry-sponsored clinical research studies. Other studies may be eligible to participate in the program, but using another template. The ACTA Program coordinator in OIC will decide if a project is eligible for the ACTA Program.

  1. Why do I need to ask the ACTA Program coordinator if this study can be part of the ACTA program?

Not all studies are eligible for the ACTA program. For example, the ACTA template may not provide appropriate terms to govern the project, or UNC and the Sponsor may already have an established template (e.g. a Master Agreement) for use.

  1. Do I still have to do a budget?

Yes. All clinical research projects at the university should be supported by an internal, detailed budget. The ACTA Program does not provide budget negotiation and the ACTA template does not contain budget and payment terms.

  1. Is the ACTA Program a permanent program?

No, the ACTA program is still in pilot form. The ACTA Program Coordinator will be collecting metrics and feedback on the ACTA program design and offerings. Let us know how you like the ACTA Program by sending your feedback to the ACTAProgram@unc.edu.

  1. Do I still have to submit to CRMS?

Yes. The CRMS submission is necessary for many reasons other than the contract negotiation. For example, the CRMS submission CRMS is the mechanism by which study subjects are associated with clinical projects. The ACTA Program is only temporarily bypass of the CRMS submission to allow the contract negotiation to begin without the CRMS submission being complete. You should begin your CRMS submission as you normally would to avoid any undue delay.

  1. Do I still have to submit to RAMSeS?

Yes. The ACTA Program doesn’t affect any other operation other than contract negotiation and execution.

  1. Do I still have to do a BCA/GCP/IRB/IDS submission?

Yes. The ACTA Program doesn’t affect any other operation other than contract negotiation and execution.

  1. How can I ensure that the ICF injury language matches the agreement?

When the Sponsor agrees to use the ACTA template in the ACTA Program, your ACTA Program Coordinator will send you the ICF injury language that is necessary to make the ICF and the contract be consistent.

  1. What if a CRO is involved?

It depends! A CROs involvement in the negotiation and/or study does not necessarily mean that a project is ineligible for the ACTA Program, but it may mean that it is less likely that the Sponsor and/or CRO will agree to use the ACTA template. Ask the ACTA Program coordinator for more information.

  1. What if the Sponsor declines to participate in the ACTA Program?

If a Sponsor decides not to participate in the ACTA program, their agreement will be negotiated through the traditional negotiation process at UNC. Notify the ACTA Program coordinator, who will work with the Office Manager to ensure that the draft agreement is submitted to OIC for review and that a contract manager will be assigned to review and negotiate the agreement.

ACTA FAQ for Sponsors

  1. What is the ACTA Program?

The ACTA Program is an initiative being piloted by the Office of Industry Contracting at The University of North Carolina at Chapel Hill, designed to speed up the contract negotiation process by utilizing an established template that has middle-ground terms for the university and most sponsors. During the initial stages of project initiation, an investigator may decide that they would like a project to be part of the ACTA program. If a project is eligible for the ACTA Program, the Investigator and the ACTA Program Coordinator (a representative of Office of Industry Contracting with special expertise in contract negotiation) will contact the Sponsor about the ACTA Program, explain Program benefits, and discuss next steps. Because both parties agree upfront to the terms and conditions of the ACTA template, the ACTA Program bypasses the traditional negotiation process.

  1. Is this program mandatory?

No, participation in the ACTA program is not mandatory, and is completely within the discretion of the investigator and subject to the acceptance of the Sponsor. Should you choose not to participate in the ACTA Program, the investigator and department may still submit your contract for negotiation at the Office of Industry Contracting using the traditional process.

  1. Why is the ACTA template selected for this program?

Although the ACTA template is ideal for neither party, it represents a fair compromise for both parties. In fact, the majority of agreements signed by the university for clinical research studies have terms and conditions that are substantially similar to the ACTA.

  1. What are the benefits of participating in the ACTA program?

The main goal of the ACTA Program is to promote efficiency and decrease contracting time. Typically, agreements at UNC take about 60 days to reach final consensus.  The ACTA Program bypasses the traditional negotiation process, allowing the parties to focus on other portions of the study start up process.  The ACTA Program Coordinator will provide expedited review and contract execution (within 2 business days of receipt of final budget).

  1. If my study is not an industry-sponsored clinical trial, does UNC have any other similar programs for other types of research?

The university is willing and able to provide other templates should the ACTA template not be suitable for the specific project. If you decide to take part in the ACTA program using another template, the same terms and program benefits (expedited review and negotiation) will apply to your project.

  1. By participating in this program, will I be bound by the terms of the ACTA in future studies?

No. You will not be bound to participate in the ACTA Program in future studies, and you will not be prejudiced in future negotiations by agreeing to use the ACTA for a specific study.

  1. Are changes to the ACTA template allowed?

The ACTA Program Coordinator may be able to accommodate some changes to the template. Discuss any project specific requests with your ACTA Program Coordinator.

  1. What if our CRO is signing the contract?

The ACTA Program may be able to accommodate some projects with a CRO as the delegated signature authority for the Sponsor. For more information on requirements regarding CROs, discuss with the ACTA Program Coordinator.

  1. Where can I get more answers?

The ACTA Program Coordinator is an expert in the ACTA template, and the ACTA Program at UNC and can answer any specific questions you may have. Reach out to ACTAProgram@unc.edu for more information.