Research Trainingprogram 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.

Klik here for program and pictures.

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:

Topics training clinical research for Japanese CRC’s

  • Nationale wet- en regelgeving
  • Europese wetgeving in verhouding tot nationale wetgeving
  • Toetsingsprocedure Nederland en Multi-center richtlijn
  • Rol en samenstelling van een Medisch Ethische Toetsing Commissie
  • Rol van de bevoegde instantie
  • Onderzoek in een fase I unit
  • Rol van een CRO/ ARO
  • Rol van de sponsor
  • Financiering van klinisch onderzoek
  • Opzet en uitvoer van investigator initiated onderzoek
  • Doel en faciliteiten van een wetenschapscommissie/ trial bureau in ene ziekenhuis
  • Datamanagement

De onderwerpen verschillen paar jaar en worden door verschillende instantie/organisatie ingevuld, zoals ziekenhuizen (academisch en topklinisch), overheid, CCMO, farmaceutische industrie,CRO’s en overige bedrijven die betrokken zijn bij het faciliteren van onderzoek in Nederland.