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CITI Program

Collaborative Institutional Training Initiative at the University of Miami

New Modules: Clinical Trial Agreement (CTA)

CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party's responsibilities and obligations for the clinical trial. It is imperative that researchers and sites understand the importance of CTA development, negotiation, and execution, as effectiveness in these areas will increase efficiency, protect researchers/sites and subjects, and help advance research.

To help meet these needs, four new modules are available from the CITI Program for no additional fee to subscribing organizations.

Overview of the CTA

Discusses the general purpose of a CTA, roles and responsibilities of parties to the CTA, and how the CTA fits into the research enterprise. The module also compares and contrasts clinical trials involving drugs, biologics, and devices from a CTA perspective.

Understanding the Terms of the CTA

Provides an overview of the context behind certain CTA terms and sections, types of language used for CTA sections, and some key elements of each section. The module also outlines what should be addressed in the key sections of the CTA and the aim for each section.

Role of the Researcher and Site in Managing the CTA

Discusses key roles of the researcher and site in managing the CTA, including initial assessment, review, and implementation. The module also describes how the CTA is linked to site policies, protocol, and informed consent form, and identifies key CTA sections that could present risk to the site.

CTA Negotiation for Researchers and Sites

Addresses strategies and preparation for CTA and study budget negotiations. The module also identifies terminology and alternative wording options to ensure a fair and balanced CTA.

Audience

Principal investigators, research staff and administrators, and other individuals involved in CTA development, negotiation, and execution.

Authors

Dex Bilkic, HBSc, MBA
Boehringer-Ingelheim

JoAnn Pfeiffer, DrSC, RAC, CCRA
Arizona State University

How to Proceed

Support

Email for more information: support@citiprogram.org

Telephone: +1-888-529-5929