Your Clinical Study Protocol inside out (Classroom 6 Oct 2020)

Description
Operational

As Clinical Research Professional, how to get the most out of your protocol for your day-to-day activities. This half-day course will focus on the content of a clinical trial protocol and how study design, statistics and risk management aspects as described in study protocol relate to your day-to-day monitoring activities, site management strategy, clinical data review, etc.

At the end, you will receive a certificate and the course hand-outs.

TRIUM reference: T0345

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Explain the purpose and importance of a protocol in a clinical investigation
  • List the minimal content requirements of a clinical trial protocol.
  • Identify and explain important design and statistical concepts within your trial protocol
  • List the requirements of risk management within trial protocols
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Gerald Van Roey
Gerald Van Roey MPhEd had over 10 years of experience in Clinical Operations before switching his career into the training business in 2009. He has worked as trainer and managing director for the ECCRT, European Centre for Clinical Research Training before starting his own company in 2015. As a clinical monitor he performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development. In his previous career he implemented different trial tools and mentored many junior CRAs. His extensive knowledge and background serves him as a manager and trainer for different courses. In his trainer function he has coached over 1000 clinical research professionals and has delivered courses in 14 different countries.