A European Approach to Clinical Investigator Training

Frontiers in Pharmacology

Heinrich eKlech¹  Esther eDaemen²  Nicolette eVerheus³  Cindy eCanivet⁴  Pierre eLafolie⁵  Catherine eCornu⁶  Jacques eDemotes⁷  Lucy eKiessig⁸  Ingrid eKlingmann⁹  Martin eLucht^1,10  Katelijne eDe Nys^1,11  Jean-Pierre eKraehenbuhl^1,12  Christiane ePauli-Magnus^1,13  Mary Jane eClark^1,14  Anthony eChan^1,15  Sandor - Kerpel-Fronius^1,16  Martina eStykova^1,17  Barbara ePeters^1,18  Ralf eSchaltenbrand^1,18  Armel eStockis^1,19  Ferdinand eHundt^1,19  Detlef eNiese^2,20  Barry eHirst^2,21  Behrouz eKassai^2,22  Jean-Marie eBoeynaems^2,23 

[1] J;ACRP;DIA;F-CRIN;HSeT;Hospices Civils de Lyon;INSERM;;J &Janssen Biologics;Karolinska University Hospital;Katholieke Universiteit Leuven;Medizinische Universität Wien;Novartis Foundation for Medical-Biological Research;Pfizer USA;Pfizer;Semmelweis University;UCB Pharma;University of Basel;University of Duisburg-Essen;University of Freiburg;University of Newcastle;Université Claude Bernard Lyon 1;Université Libre de Bruxelles;

关键词: Certification;    Clinical Trials as Topic;    training;    GCP;    clinical investigator;   

DOI  :  10.3389/fphar.2013.00112

来源: DOAJ

【 摘 要 】

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 ECRIN (European Clinical Research Infrastructures Network)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.

【 授权许可】

Unknown