Clinical Trial Agreements (CTAs)

Provides sites and investigators an overview of CTA development, negotiation, and execution.

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About this Course

CTAs are one of several key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines 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.

This course supplements the foundational training provided in the Biomedical Basic course. Organizations may add the modules in this course to their basic HSR courses to provide learners with focused CTA training.

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Language Availability: English

Suggested Audiences: Individuals involved in CTA development as well as CTA negotiation and execution, Principal Investigators (PIs), Research Staff and Administrators

Organizational Subscription Price: Included with Human Subjects Research series, available as part of an organizational subscription package or for $1,000 as an add-on to current subscriptions.
Independent Learner Price: $29 per person

Demo Instructions

Course Content

Overview of the Clinical Trial Agreement (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. It also compares and contrasts clinical trials involving drugs, biologics, and devices from a CTA perspective.

Recommended Use: Required
ID (Language): 17356 (English)
Author(s): Dex Bilkic, HBSc, MBA - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Understanding the Terms of the Clinical Trial Agreement (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. It also outlines what should be addressed in the key sections of the CTA and the aim for each section.

Recommended Use: Required
ID (Language): 17357 (English)
Author(s): Dex Bilkic, HBSc, MBA - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Role of the Researcher and Site in Managing the Clinical Trial Agreement (CTA)

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

Recommended Use: Required
ID (Language): 17358 (English)
Author(s): Dex Bilkic, HBSc, MBA - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Clinical Trial Agreement (CTA) Negotiation for Researchers and Sites

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

Recommended Use: Required
ID (Language): 17359 (English)
Author(s): Dex Bilkic, HBSc, MBA - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

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