Clinical Trials

The University of Florida’s faculty and staff participate in numerous clinical trial projects, studying investigational drugs or devices. This website is designed to provide guidance and information about DSP’s Clinical Trial Procedures. HSC faculty and staff must also follow the procedures of the Research Administration and Compliance Office.

Clinical Trials and Non-Disclosure Agreements Processing Guides

If you need to know how to process a clinical trial or non-disclosure agreement for DSP signature then please go to our Clinical Trials or Non-Disclosure Agreements Processing Guide.

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.

CTA Budgets

Clinical studies are usually funded on a per-patient basis with provisions for pro-rated payment for patients who do not complete the study. All costs necessary to conduct the study, including salaries, procedures, services, supplies and indirect costs, should be considered when determining the fixed per-patient amount.

ClinicalTrials.gov Guidance

Division of Sponsored Programs, College of Medicine Research Administration and Compliance, Clinical and Translational Science Institute and Institutional Review Board collaborate together to assist UF faculty and staff in the registration of all applicable clinical trials and to maintain FDAMA and FDAAA compliant records.