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.
Background and history to Clinical Trials legislation
Declaration of Helsinki
Historical context and drivers
Development of international GCPs
Responsibilities of Ethics Committees, Sponsors and Investigators
FDA inspections overview
EU Directives governing clinical research
European legal framework
Clinical Trials Directive
Clinical Trials Guidelines
UK Statutory Instruments (optional)
Human Tissue Act
UKECA and NRES