Dataset Information

A European approach to clinical investigator training.

ABSTRACT: 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.

SUBMITTER: Boeynaems JM

PROVIDER: S-EPMC3766792 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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A European approach to clinical investigator training.

Boeynaems Jean-Marie JM Canivet Cindy C Chan Anthony A Clarke Mary J MJ Cornu Catherine C Daemen Esther E Demotes Jacques J Nys Katelijne De KD Hirst Barry B Hundt Ferdinand F Kassai Behrouz B Kerpel-Fronius Sandor S Kiessig Lucy L Klech Heinrich H Kraehenbuhl Jean-Pierre JP Lafolie Pierre P Lucht Martin M Niese Detlef D Pauli-Magnus Christiane C Peters Barbara B Schaltenbrand Ralf R Stockis Armel A Stykova Martina M Verheus Nicolette N Klingmann Ingrid I

Frontiers in pharmacology 20130909

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 orga ...[more]

PMID: 24058345

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Project description:BackgroundInvestigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists.MethodsTo fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action.ResultsThe survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries.ConclusionsThere is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.

Dataset Information

A European approach to clinical investigator training.

Publications

A European approach to clinical investigator training.

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