This document is the cornerstone of standards for clinical trial conduct, and it is essential that all clinical researchers are fully familiar with it. We can provide up to date training on the requirements of the latest version of ICH E6 and application of the principles and requirements in the planning and execution of clinical trials.
With the focus firmly on Participant Protection and Data Quality this course can cover the back ground and history of GCP, Roles and Responsibilities and Documentation.
Who is it suitable for?
This course is suitable for those who need training on ICH GCP requirements for clinical trials. It can be tailored to the audience, for example Clinical Operations Groups, Medical Advisors, CRAs, CTAs, Clinical Project Managers, Investigators, Research Nurses, Ethics Committee members.
To provide delegates with an understanding of:
- The background to ICH GCP and its adoption
- Requirements of ICH GCP.
- How those requirements impact on clinical trial conduct and specific clinical trials roles
Delivery of the course consists of a combination of presentations by the trainer, group discussion and case studies. This course is also supported by additional resources available from our website.
This course is usually delivered as a one day classroom session, but can be tailored to fit requirements.
ICH GCP Introduction
- ICH E6(R2) Background and history
- ICH E6 the future – proposed changes and implications
- ICH E8 update
ICH GCP Content
- Principles and terminology
- Responsibilities of the Ethics Committee or Institutional Review Board (IEC or IRB)
- Responsibilities of the Investigator
- Responsibilities of the Sponsor
- The protocol
- The investigators brochure
- Essential documents and the trial master file
Please contact me for more information and to organise your course.
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