Clinical Trial Agreements

What is Clinical Research vs. a Clinical Trial?

Clinical research is the study of health and illness in human subjects.  Clinical research studies are divided into two types:

While NIH, FDA, and ClinicalTrials.gov use the term “clinical trial” in reference to interventional studies, many organizations use the terms “clinical trial” and “clinical research” interchangeably.

What is a Clinical Trial Agreement (CTA)?

A Clinical Trial Agreement (CTA) or Clinical Research Agreement is a legally binding agreement that manages the relationship between

  1. the clinical research sponsor which may be providing the study drug or device, the financial support, and /or proprietary information and
  2. the study site which may be providing data and/or results, publication, and/or input into further intellectual property.

When is a CTA Used?

A CTA is typically used for industry-sponsored clinical research studies to 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.

Who Negotiates CTAs for UF?

The UF Office of Clinical Research (OCR) contracting team negotiates all UF CTAs.

What CTA Template is Used at UF?

The OCR Contracting team prefers to utilize the Accelerated Clinical Trial Agreement (ACTA) template as a starting point when negotiating with sponsors:

How are CTA Requests Processed?

The Office of Clinical Research (OCR) contracting team processes all UF CTAs through the UFIRST agreements module.

Questions?