Face-to-face and blended
learning for corporate clients
To provide an overview of the history of GCP
To understand the key principles of GCP, including - informed consent, ethics committees, the key roles (sponsor, monitor and investigator), GMP and IMP, safety reporting, and reporting.
To identify and discuss key GCP and Clinical Trial Directive problem areas.
This course is designed for all clinical research professionals operating within the EU.
1. Overview of the history of GCP
• What is GCP and why is it needed?
• History and development of GCP in EU and US and where are we now?
• Managing problem areas of working to GCP and the CTD
• Impact of GCP globally and key FDA differences in GCP
2. The Clinical Trial Directive (CTD)
• Overview of the CTD - What are the additional responsibilities and activities for the sponsors, investigators, Ethics Committees and regulatory authorities?
3. Study set up planning and preparation so as to comply with GCP and the CT Directive
• including obtaining a EudraCT number, and the CTA application
4. Informed Consent procedures
• Ensuring that informed consent procedures are properly implemented
• Special requirements for consenting vulnerable subjects (eg minors)
5. Ethics Committees (ECs) and Institutional Review Boards (IRBs)
• Composition, procedures and records to comply with GCP
• The latest requirements for ECs
6. How to select Investigator sites to comply with GCP and the CTD
• Selecting investigators and carrying out site selection visits
• Understanding the importance of investigator selection for laying the foundation to the trial
7. Investigator Responsibilities
• Qualifications and training of the investigator and study team
• Communication and reporting to the sponsor
8. Managing Clinical Trials to GCP and the CTD: Discussion of some key areas of GCP open to interpretation including -
• Archiving - how long, where and how?
• SourceDocument Verification - how much, how to document, e-source?
• Handling substantial amendments, administrative changes, non-substantial amendments
9. Responsibilities of the Sponsor including the Monitor
• Understanding the key roles and responsibilities of the sponsor
• The important role of the monitor for GCP compliance
• Annex 13 label requirements
10. GMP meets GCP: Manufacturing and import authorisation, packaging, labelling, handling of Investigational Medicinal Product (IMP)
11. Safety reporting requirements
• Understanding the basic definitions
• SUSAR reporting, expedited reporting, periodic safety updates
12. The Trial Master File and Archiving
• What are the essential documents that are required to ensure that the study complies with GCP and the CTD?
• The content of the TMF at sponsor and investigator sites
13. The Protocol, and the Investigator Brochure
• Awareness of topics to be included in the protocol and investigator brochure
14. Principles of Quality Assurance: Audit and inspection to comply with GCP and CTD
• How to prepare for an audit and/or regulatory Inspection
• The latest inspection policies and findings
15. Fraud: How to be able to detect fraud
• What are the signs to look for?
• What actions should the company take?
16. Final questions and close