A European approach to clinical investigator training

作者：Boeynaems Jean Marie^*; Canivet Cindy; Chan Anthony; Clarke Mary J; Cornu Catherine; Daemen Esther; Demotes Jacques; De Nys Katelijne; Hirst Barry; Hundt Ferdinand; Kassai Behrouz; Kerpel Fronius Sandor; Kiessig Lucy; Klech Heinrich; Kraehenbuhl Jean Pierre; Lafolie Pierre; Lucht Martin; Niese Detlef; Pauli Magnus Christiane; Peters Barbara; Schaltenbrand Ralf; Stockis Armel; Stykova Martina; Verheus Nicolette; Klingmann Ingrid

来源：Frontiers in Pharmacology, 2013, 4: 112.

DOI：10.3389/fphar.2013.00112

• clinical trials as topic
• clinical investigator
• training
• GCP
• certification

A better education and training of clinical investigators and their teams is one of the factors that could foster the development of clinical research in Europe, a key objective of the Innovative Medicines Initiative (IMI). PharmaTrain (an IMI programme on training in medicines development), and European Clinical Research Infrastructures Network (ECRIN) have joined forces to address this issue. An advisory group composed of representatives of universities, pharmaceutical companies and other organisations met four times between June 2011 and July 2012. This resulted in a position paper proposing a strategy to improve and harmonize clinical investigator training in Europe, and including a detailed syllabus and list of learning outcomes. Major recommendations are the establishment of minimal and mutually recognized certification requirement for investigators throughout the EU and the creation of a European platform to provide a suitable course and examination infrastructure.

• 出版日期2013