Description:

This course provides a basic working knowledge of GCP.

Who it is suitable 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.

Example content:

Background and history to Clinical Trials legislation

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

ICH GCP

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

FDA 21CFR

• Background
• Key differences
• FDA inspections overview

EU Directives governing clinical research

• European legal framework
• Clinical Trials Directive
• Clinical Trials Guidelines
• GCP Directive
• GMP Directive

UK Statutory Instruments (optional)

• Clinical Trials
• Human Tissue Act
• UKECA and NRES