This highly interactive workshop offers both advanced knowledge of GCP (Good Clinical Practice) and the clinical research rules and regulations, including the latest European ones, as well as practical skills in the monitoring of clinical trials. After you finish this course, you will have an excellent basis to apply for a job in clinical research and to fulfil the roles of a Clinical Research Associate (CRA).
This highly interactive workshop both offers advanced knowledge of GCP (Good Clinical Practice) and the clinical research rules and regulations, including the latest European ones, as well as practical skills in the monitoring of clinical trials. It will provide students with an excellent basis to fulfil the roles of a Clinical Research Associate.
During the first week, the emphasis will be on the necessary theoretical basis about the theory and principles of GCP and all aspects of clinical monitoring, such as research design, the various 'players', visits, essential documents, data management, safety assessment and compliance. Role plays, guest lectures and various workshops will be part of the program. In the second week the focus will be on the practical aspects of monitoring, during which various documents, such as source documents and CRFs will be monitored. A workshop on job application skills is included, as well as on topics such as market access, medical devices, ethical issues and communication skills.
The course is taught by experienced tutors in the work field, and various guest lecturers from the field of clinical research.
- Hans Vehof, MSc
- Paul de Koning, PhD
and various experts from the work field
Nurses, physicians, pharmaceutical business administrators, CRO and pharmaceutical industry employees and anyone interested in GCP and clinical trials. No specific prior clinical trial experience is necessary.
Students will gain advanced knowledge of the principles on which clinical trials are based. Furthermore, the purpose of this course is to obtain practical experience in clinical trial monitoring. The program includes role plays, workshops and debates, which will lead to a better understanding of the ins and outs of the pharmaceutical industry, clinical research and monitoring skills.
70 hours of lectures, workshops, and self-study during two weeks.
Housing through: Utrecht Summer School.
Housing fee is the total fee for both weeks.
Hans Vehof | E: firstname.lastname@example.org | T: +31 6 250 98 999