Description

Clinical Research Related Courses

A good clinical study stands or falls with a good clinical study protocol. A protocol might be of high scientific value and might look perfect from a theoretical point of view. But when you bring it to the clinic, this is often when things start to get wrong. Are you involved in the development, evaluation or implementation of clinical study protocols? This course is a good starting point for you then.

The topics of this 1-day course range from the basic concepts and content of a study protocol over the regulatory requirements for it up to creating amendments. You will learn who is involved in the protocol development process and what roles are coming into play. Using practical examples and workshop you will learn best practices to match theory with practice. This course focusses on interventional clinical studies.

Course time
09h00 - 17h00
Who should attend

Investigators, Medical writers, Clinical Project Managers and other Clinical research professionals with little to no background in the writing of clinical study protocols.

Programme highlights
  • Fundamentals of the study design
  • Content of clinical study protocols
  • ‘Protocol amendments’ and ‘protocol administrative changes’
  • Tools/suggested practices to improve protocol development
Learning Objectives
  • Fundamentals of the study design
  • Content of clinical study protocols
  • ‘Protocol amendments’ and ‘protocol administrative changes’
  • Tools/suggested practices to improve protocol development

Book a course

No session currently available.
In case of interest, please contact us.
 

Testimonials

Denise Mayes-Gascard
January 2016
Company
Sanofi

I have appreciated working with ECCRT. I have found Benedikt to be a motivated and interested trainer, who has worked with me to improve training activities, learning from experience, and rectifying things that did not work as planned initially. A successful and enjoyable collaboration.