Clinical Trial Overview: The Players, Process & Language, Fall 2013
Clinical Trial Overview is the prerequisite for Managing Clinical Trials. Anyone interested in taking both classes together may qualify for special pricing. Multiple enrollments from a single company will also qualify for additional discounted pricing. Contact Julie Deschenes at email@example.com for more information.
Clinical trials evaluate investigational methods – including drugs, devices, biologics, and combinations – for treating, diagnosing, and preventing various diseases, disorders, and conditions. Clinical trials are required to gain approval to market a product, are expected to generate high quality data, and must demonstrate adherence to regulatory and ethical standards. This 2-session, 7-hour course will provide an overview of those involved (the players), how trials work (the process), and the basic terminology of clinical trials (the language).
At the end of the session, you will be able to:
- Describe the process of getting a product from discovery, through clinical trials, and to the marketplace.
- Explain the players in the clinical trial process and their roles.
- Define the purpose and objectives for Phase 1-3 clinical trials.
- List common types and designs of Phase 1-3 clinical trials, as well as the most common terms used.
- Explain the flow of a clinical trial and the most common challenges of each phase.
- Describe the ethical standards that clinical trials are expected to follow.
- Discovery to Dispensing: The development-to-approval pipeline
- The Development Team: Sponsor, Regulator, IRB, Monitor…and many others
- The Clinical Trial Process
- Overview of Phases 1-3
- Terms and Acronyms
- Common Trial Designs
- Trial Conduct…the ethics and the challenges
Tina Forrister, M.A., has been with Halloran Consulting Group since 2008. She focuses on maximizing client performance by assessing organizational challenges and recommending actionable solutions, designing and delivering customized learning and development programs, and optimizing quality systems and processes. Tina has over 15 years of clinical research expertise in the areas of clinical project and program management, process development and improvement, and training.