Good Clinical Practice ( GCP)Training Course 2023
Good Clinical Practice Training ( GCP) Course
This session will describe the purpose of Good Clinical Practice (GCP) and outline the significant milestones in the history of GCP development. It will look at the impact of ICH GCP changes on investigator sites and sponsors. The current legislation relating to clinical trials and medical devices will be discussed. The practical application of GCP will be reviewed.
Course Lead: Sue Fitzpatrick
Session Agenda
08.30 - Welcome and Introduction
History and purpose of GCP - Development of ICH GCP - Roles and responsibilities in clinical research according to ICH GCP
- Sponsor
- Monitor
- Investigator
- Ethics Committees
- ICH GCP E6 R2
-Changes in Data Protection with GDPR
UK Clinical trial legislation.
- The EU Clinical Trial Regulation 536/2014, Directive 2001/20/EC and GCP Directive 2005/28/EC in addition the Directive 93/42/EEC on medical devices (EU MDD) Directive 90/385/EEC on active implantable medical devices (EU AIMDD) Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) and current position
- The UK Statutory Instruments
10.00-10.30 Break
- GCP in action
- Essential Documentation
- Maintaining data integrity
- Informed consent
- Safety reporting
- Drug accountability
- Enforcement procedure
On completion of the session, a GCP certificate will be awarded.
Should you have any queries, please contact the BOA Events Team via [email protected]