Research training program for Clinical Research Coordinators from Japan
In 2007 Penthecilia was asked by the Japanese Society Clinical Pharmacology and Therapeutics (JSCPT) to develop a training program for Japanese CRC’s. In collaboration with the Transfergroep Rotterdam a one week research training program has been developed.
The objectives of the CRC training program is the second step to educate some CRCs to become experienced trainers of young CRCs. JSCPT selects 3 candidates every year to go abroad to participate this program. They have been involved in clinical trials as a full-time worker(40hours/week) for several years. Their professions are nurses, pharmacists or medical technologists.
The foreign program is financially supported by a contribution from JPMA (Japanese Pharmaceutical Manufacturers Association).
During the course the participants visit several research organisations and hospitals involved in clinical research who will present the conduct of clinical research in the Netherlands. Alongside the lectures an active learning process will be stimulated by discussions on various topics and cases.
If you are interested in training courses tailor made, e.g., for foreign customers who should be trained in the law and legislation of the Netherlands, you can contact Cecilia Huisman: firstname.lastname@example.org
Topics training clinical research for Japanese CRC’s
- Dutch law and regulations
- European law and regulations
- Review research protocol in multi centre studies
- Ethic committees: goals and regulation
- Competent authority
- Research phase I unit
- Involvement of a CRO/ARO
- Responsibilities of the sponsor and the investigator
- Budget and finance
- Investigator initiated research
- Research facilities in a hospital
- Data management
Every year the agenda of the training change. There are a number of organizations involved: hospitals (teaching – and academic), government, competent authority, pharmaceutical companies, CRO’s and other companies who facilitate research in the Netherlands.