Clinical Trial Overview

  1. The Principal Investigators (PI) or PI staff should provide College of Medicine Research Administration and Compliance Office (RAC) with a copy of the proposed CTA, study letter if Master CTA is being used, a copy of the protocol, Clinical Trial Checklist, and a company contact person as early in the process as possible. These items may be delivered to RAC using UFIRST-Proposal Workflow.
  2. Clinical Trial Master Agreements provide agreed-upon terms and conditions establishing the basic relationship between the University and a Sponsor. Once a Master Agreement is in place, a “study letter” or “task order” is generated by the sponsor for each new study to be conducted under the Master Agreement. The study letter sets forth the conditions that are unique to the study, such as dollar amount, protocol name, and principal investigator.
  3. RAC can begin review, but prefers to begin negotiating with the sponsor when the completed CTA checklist is received. The CTA checklist provides critical information about the trial that is needed in order to finalize the CTA or study letter terms and conditions.
  4. The CTA or study letter cannot be signed by UF until the completed UFIRST Proposal is received, as well as any other appropriate information which would be conveyed to the PI by RAC during negotiations.
  5. IRB approval is not necessarily required to execute an agreement, but is required prior to commencing work under the CTA or study letter.
  6. Once the terms of the CTA or study letter have been negotiated and all other required documents are on file, DSP will sign the CTA or study letter and return it to the company contact, unless otherwise directed. If the Investigator’s signature is needed to acknowledge the terms of the CTA or study letter, DSP or RAC will collect such signature prior to signing and returning the agreement to the company.