Face-to-face and blended
learning for corporate clients
UK GCP Overview
Duration: 2 days
Key Objectives:
Understand the principles of ICH GCP and the European GCP requirements for the Clinical Trial Directive (EU Directive 2001/20/EC and EU Directive 2005/28/EC).
Gain knowledge of the UK requirements for GCP and the UK law: The Medicines for Human Use (Clinical Trials) Regulations 2004 and amended regulations.
Trainer:
Dr Laura Brown - Course Director, MSc Clinical Research at Cardiff University, UK.
Course Syllabus:
1. Introduction & the principles of ICH GCP
• Background to GCP
• Principles of GCP
• EU Directive 2001/20/EC and EU Directive 2005/28/EC
2. Informed Consent
• Informed consent requirements
• Consent in emergency situations
• Inclusion of minors and incapable adults
3. Ethics Committees
• IRAS
• Responsibilities
• Composition, function and Operations
4. Investigator Responsibilities
• Responsibilities of the Investigator
• Compliance with the protocol
• Medical care of subjects
5. Sponsor Responsibilities
• Responsibilities of the sponsor
• Handling and supplying IMP
• Role of the monitor
6. Clinical Trial Documentation
• The Protocol
• The Investigator Brochure
• Essential documents
7. Safety Reporting
• Definitions
• Responsibilities
• What to report, when and how
8. Specific UK Requirements, inc -
• What are the regulatory requirements in the UK?
• The main requirements of the Medicines for Human Use (Clinical Trials) Regulation 2004 (S.I. 2004/1031) (Discussion)
• The UK S.I. 1928
• Emergency consent
• The requirement to report serious breaches in GCP to the MHRA
