Contractual Elements of a CTA
Each CTA is reviewed on a case-by-case basis; however there are a number of contractual items that are common to most CTA agreements. The following is just a sample of common elements found in a CTA that may need to be negotiated by DSP or RAC with the Sponsor:
- Parties to the Agreement
- The parties to the Agreement should be by and between the University of Florida and the Sponsor. The Investigator as an employee of the university should not be named as a legal party to the Agreement. We do allow the Investigators to sign CTA’s as Read and Acknowledged if the Sponsor insists.
- Agreements must allow the Investigator the ability to publish results of the study. We do afford the sponsor a right of prior review for purposes of identification of proprietary or confidential information or intellectual property protection. Where UF is one site of a multi-site trial we do allow sponsors to coordinate timing of publications among the sites.
- The University of Florida does not allow the sponsor to freely use our name or the name of the University’s project staff in any publicity, advertising, or press release without the express prior written approval of an authorized representative of University.
- Intellectual Property
- The drug or device being tested in the clinical trial is normally proprietary and owned by the sponsoring party and may already be covered by patent protection. Although each CTA must be reviewed on its own merit, it is the University of Florida’s general policy that title to inventions arising from projects conducted by faculty and staff will be owned by the University.
- The sponsoring party, and the actual owner of the study drug or device if an intermediary is involved, normally shall provide to indemnify and hold harmless the University of Florida from any and all liabilities, claims, actions or suits for personal injury or death arising from the conduct of the CTA.The University of Florida cannot provide indemnification.
- Governing Law
- Agreements should be governed by the laws of the State of Florida or this provision must be absent from the agreement.
- Subject Injury Compensation Language
- It is DSP procedure to negotiate appropriate compensation language for subject injury in all CTA’s. The language should be similar to one of the variations vetted and approved by UF General Counsel.
- VA Approved Contract Language
- If the UF Clinical Trial Checklist identifies that the study is supported by the VA or conducted at a VA facility or targets VA subjects then the CTA must include VA approved contract language. This is one of UF’s roles to help the VA maintain its AAHRPP accreditation.