Essentials of Clinical Trial Budgets

Foundational course on how to develop, negotiate, and implement a clinical trial budget.

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About this Course

This in-depth course provides practical knowledge on how to develop, negotiate, and implement a clinical trial budget from the perspective of the clinical site. It details what goes into budget planning and reviews criteria for measuring direct and indirect costs. The course outlines how to assess clinical trial feasibility and calculate procedural costs, while offering a primer on negotiating study budgets in ways that produce fair and mutually acceptable outcomes.

Course Preview:

Language Availability: English

Suggested Audiences: Academic and Private Research Clinics, Budget Professionals, Clinical Research Coordinators (CRCs), Faculty, Investigators, Research Administrators

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions

Course Content

Introduction to Clinical Trial Budgets

Describes the purposes of budget development. The module introduces the principal parts of a clinical trial budget, defines direct and indirect costs, and highlights the characteristics of different sponsors.

Recommended Use: Required
ID (Language): 20770 (English)
Author(s): Christina Brennan, MD, MBA - Northwell Health

Budget Development Basics

Discusses the basic process of clinical trial budget development. The module describes what goes into budget planning and identifies the primary stakeholders involved in creating a clinical trial budget.

Recommended Use: Required
ID (Language): 20771 (English)
Author(s): Christina Brennan, MD, MBA - Northwell Health

Clinical Trial Feasibility

Investigates the meaning of clinical trial feasibility while explaining the importance of reviewing and analyzing the protocol as part of the feasibility process. The module identifies considerations for assessing the resources and tools needed to conduct a trial. It highlights the importance of accurate enrollment projections in determining whether a clinical trial is a good fit between the sponsor and clinical site.

Recommended Use: Required
ID (Language): 20772 (English)
Author(s): Christina Brennan, MD, MBA - Northwell Health

Procedural Costs in a Study Budget

The module aims to help sites develop a budget that encompasses all potential study costs. It defines procedural costs, discusses how procedural costs form the foundation of a study budget, describes how to find and review procedural costs, and explains common terminology and procedural codes. The module also examines the utilization of chargemasters and explains how to apply a Medicare Coverage Analysis to study budget development.

Recommended Use: Required
ID (Language): 20773 (English)
Author(s): Christina Brennan, MD, MBA - Northwell Health

Developing the Study Budget

Describes the phases of budget development, including preparing, developing, approving, negotiating, executing, implementing, and monitoring the budget. The module also discusses common study startup costs, direct and indirect costs, and costs per enrolled subject.

Recommended Use: Required
ID (Language): 20774 (English)
Author(s): Christina Brennan, MD, MBA - Northwell Health

Negotiating the Study Budget with the Sponsor

The module examines the negotiation process and negotiating principles. It describes the serial steps in negotiation: preparing, exchanging, clarifying and justifying, bargaining, and finally agreeing. It also explains how to prioritize non-negotiable items and use evidence-based justification for costs, such as fair market value, to ensure that a site receives proper compensation.

Recommended Use: Required
ID (Language): 20775 (English)
Author(s): Christina Brennan, MD, MBA - Northwell Health

CME/CEU Credits

To earn CE credits and units, you need to be affiliated with an organization that subscribes to this course or subscribe as an independent learner first. Learn more about CE/CME Credits.

Profession

Type

Credits

Designation Period

All Participants

IACET CEU

Maximum 0.6 CEUs
(6 CE Certified modules)
No charge

August 1, 2024
July 31, 2027

FAQs

Who should take the Essentials of Clinical Trial Budgets course?

The course is specifically intended for those who are new to the responsibility of creating, negotiating, and implementing a study budget. It can also be useful for organizations needing onboarding training for new research administrators. The intended audience includes research site administrators at academic and industry research clinics, budget professionals, investigators, clinical research coordinators, and other key research study staff.

How does the Essentials of Clinical Trial Budgets course complement other CITI Program courses?

The Essentials of Clinical Trial Budgets course complements CITI Program’s other courses covering budgeting for clinical trials, including Clinical Trial Billing Compliance (CTBC), Clinical Trial Agreements (CTAs), and Clinical Research: An Introduction.

Why should someone take Essentials of Clinical Trial Budgets?

This course prepares staff who are new to the responsibility of creating, negotiating, and implementing a study budget. The content provides the foundational knowledge needed to complete these complicated tasks.

How long will the course take a learner to complete?

This course consists of six (6) modules. Each module contains detailed content and a quiz, as well as images and supplemental materials.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, they can complete them at their own pace. Modules are each designed to take about 30 to 45 minutes to complete, which means the entire course could take about three to four hours to complete.

Is this course eligible for continuing medical education credits?

Yes. This course is eligible for IACET CEUs at no cost. CITI Program is accredited by the International Accreditors for Continuing Education and Training (IACET) and offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Standard. IACET is recognized internationally as a standard development organization and accrediting body that promotes quality of continuing education and training.

What are the required modules for learner groups?

This course is designed to be completed sequentially through its six modules (we recommend they are set as “required”).

Required modules:

Introduction to Clinical Trial Budgets
Budget Development Basics
Clinical Trial Feasibility
Procedural Costs in a Study Budget
Developing the Study Budget
Negotiating the Study Budget with the Sponsor

What are the advantages of CITI Program's Essentials of Clinical Trial Budgets?

This course provides role-specific, peer-reviewed training written by an expert clinical trial budget professional. Along with CITI Program's advantages, including our experience, customization options, cost-effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for clinical trial budget training.

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