Five years ago, the conduct of clinical trials according to Good Clinical Practice (GCP) principles was introduced as a European Union regulatory requirement by the Clinical Trial Directive 2001/20/EC. However, despite overall commitment and best intentions to apply these requirements in clinical trials, monitoring, audits and inspections regularly find complexity and lack of harmonization of varying levels of severity.
This indicated a need for those involved in the conduct of clinical trials in Europe to share their experiences with this clinical trial directive.
To further promote awareness about the current legal framework, the EORTC Headquarters in collaboration with the European Forum for Good Clinical Practice (EFGCP) took the initiative to develop a one day interactive investigator training course on GCP in clinical trials. This course, “EORTC interactive workshop on GCP: 5 Years Experience with the EU Clinical Trials Directive and its Implications on Your Clinical Research Practice”, was held for the first time on 24 April 2009 at EORTC Headquarters in Brussels.
The topics covered in this course included GCP principles, set-up of a clinical trial at the investigative site, GCP compliance in document management, involving patients in clinical trials, critical elements of conducting clinical trials, what happens when things go wrong, and EudraVigilance – safety reporting of investigational medicinal products. The EFGCP faculty for the workshop included Dr. Ingrid Klingmann, Expert in Drug Development Planning and Site Management Support, Pharmaplex bvba, Brussels, Belgium, Dr. Frank Wells, Expert in Misconduct and Fraud in Clinical Research, Ipswich, United Kingdom, Genevieve Decoster, ISO9000 Lead Auditor, IT & GCP Consulting sprl, Crupet, Belgium, and Prof. JanHasker Jonkman, Professor in Quality Management in Drug Research and Manufacturing, University of Groningen, The Netherlands.
The EORTC / EFGCP Course was accredited by the Accreditation Council of Oncology in Europe (ACOE) and granted 6 European CME credits. It was attended by 60 participants representing six countries and 24 institutions in Europe.
The efforts of EORTC Headquarters staff including Christine de Balincourt (Head of the EORTC Quality Control Unit), Marie-Laure Couvreur (Quality and Process Manager), and Cindy Wyns (Head of the EORTC Quality Systems and Compliance Unit), and Fanny Senez, Chief Operating Officer EFGCP, in organizing this GCP Course are gratefully acknowledged. It is planned to organize such a course on an annual basis.