A European approach to clinical investigator training

被引：10

作者：

Boeynaems, Jean-Marie ^{[1
]}

Canivet, Cindy ^{[2
]}

Chan, Anthony ^{[3
]}

Clarke, Mary J. ^{[4
]}

Cornu, Catherine ^{[5
]}

Daemen, Esther ^{[6
]}

Demotes, Jacques ^{[7
,8
]}

De Nys, Katelijne ^{[9
]}

Hirst, Barry ^{[10
]}

Hundt, Ferdinand

Kassai, Behrouz ^{[11
,12
]}

Kerpel-Fronius, Sandor ^{[13
]}

Kiessig, Lucy ^{[14
]}

Klech, Heinrich ^{[15
]}

Kraehenbuhl, Jean-Pierre ^{[25
]}

Lafolie, Pierre ^{[16
]}

Lucht, Martin ^{[17
]}

Niese, Detlef ^{[18
]}

Pauli-Magnus, Christiane ^{[19
]}

Peters, Barbara ^{[20
]}

Schaltenbrand, Ralf ^{[11
]}

Stockis, Armel ^{[21
]}

Stykova, Martina ^{[22
]}

Verheus, Nicolette ^{[23
]}

Klingmann, Ingrid ^{[24
]}

机构：

[1] Univ Libre Bruxelles, Erasme Hosp, Pharmed, B-1070 Brussels, Belgium

[2] F CRIN, Toulouse, France

[3] Pfizer Healthcare Ireland, Dublin, Ireland

[4] Pfizer USA, Detroit, MI USA

[5] Hosp Civils Lyon, Ctr Invest Clin, Lyon, France

[6] Assoc Clin Res Profess, Alexandria, VA USA

[7] European Clin Res Infrastruct Network, Paris, France

[8] INSERM, Paris, France

[9] Katholieke Univ Leuven, Leuven, Belgium

[10] Univ Newcastle, Newcastle, NSW 2300, Australia

[11] Univ Duisburg Essen, Essen, Germany

[12] Univ Lyon 1, Lyon, France

[13] Semmelweis Univ, H-1085 Budapest, Hungary

[14] Johnson & Johnson, Slough, Berks, England

[15] Med Univ Wien, Vienna, Austria

[16] Karolinska Univ Hosp, ECRIN, Stockholm, Sweden

[17] Univ Freiburg, Freiburg, Germany

[18] Novartis Fdn Med Biol Res, Freiburg, Germany

[19] Univ Basel, Basel, Switzerland

[20] Univ Basel, Clin Trial Unit, Basel, Switzerland

[21] UCB Pharma, Braine lAlleud, Belgium

[22] DIA, Basel, Switzerland

[23] Johnson & Johnson, Amsterdam, Netherlands

[24] European Forum Good Clin Practice, Brussels, Belgium

[25] Hlth Sci e Training, Epalinges, Lausanne, Switzerland

来源：

FRONTIERS IN PHARMACOLOGY | 2013年 / 4卷

关键词：

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

D O I：

10.3389/fphar.2013.00112

中图分类号：

R9 [药学];

学科分类号：

1007 ;

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 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.

引用

页数：5