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Course Details

Course Title

Introduction to GCP
Course Format

One or two day classroom course with a combination of presentations and workshop sessions
Learning Objectives

By the end of this course participants will be able to:

  • Describe the two key principles of GCP
  • Outline the main responsibilities of the Ethics Committee, Investigator and Sponsor
  • Apply GCP principles in the conduct of clinical trials
Who is it for?

This course is aimed at those new to clinical research. The content can be tailored to the function of the audience, for example, CRAs, CTAs, support staff, staff from service providers.
Course Content

Background and history to Clinical Trials legislation

  • Nuremberg Code
  • Declaration of Helsinki
  • Historical context and drivers
  • Development of international GCPs

ICH GCP (R2)

  • Background
  • Contents
  • Responsibilities of Ethics Committees, Sponsors and Investigators
  • Essential Documents

FDA 21CFR

  • Background
  • Key differences
  • FDA inspections overview

EU Legislation governing clinical research

  • European legal framework
  • Clinical Research Directives
  • Clinical Trials Guidelines
  • Clinical Trials Regulation

UK Statutory Instruments (optional)

  • UK Clinical Trials Legislation
  • The Grey Guide
  • UK Approvals Process
Enquire About This Course
In-House Enquiry
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