Clinical Trial Agreement
Managing the relationship between a study sponsor and an institution
A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication and input into further intellectual property.
It is important to have a CTA for allocation of risk, responsibility, funds, obligations and the protection of academic, legal, intellectual property and integrity.
A CTA should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract and possibility of amending contract terms in the future.
The Office of Business and Industry Contracts (OBIC) at the Office of Sponsored Programs (OSP) works with investigators and sponsors to develop CTAs acceptable to the investigator and to the university. It is important to involve the designated sponsored program officer as soon as you have received essential documents such as the protocols and template CTA.
Each CTA is signed by an authorized signatory within the Office of Sponsored Programs on behalf of the University. The CTA cannot to be signed by an individual researcher or investigator.
NOTE: The Center for Clinical Research Management (CCRM) or Clinical Trials Office (CTO) will manage the execution of the CTA development for most clinical trials, if your research group is part of the CCRM or CTO. If you are part of one of these groups, please reach out to your study implementation or finance team for assistance with the CTA.
It is important to review the template for monitoring, adverse event reporting, clinical supplies and accountability, requirements for invoicing if applicable, payment disbursement, study close out and data archiving terms. Some of these terms may be negotiable; communicate your concerns with your sponsored program officer or CTO/CCRM financial contact.