EFGCP Report on

The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe and Beyond

 

Every Member State in the European Union has now adopted the EC Directive on Clinical Trials, published in 2001. Based on the principles of Good Clinical Practice, this Directive required Member States to have in place a system of ethical review of research projects that would inspire confidence in the conduct of clinical research throughout Europe. However, sponsors and academic research institutions have had great difficulty in finding out what these systems are, as they are all different. A sub group of the EFGCP Ethics Working Party has tackled the challenge of identifying what over thirty aspects of the ethical review process is for each member state, plus Norway and Switzerland, and has brought this information together in a Report that will be an invaluable reference document for any company, academic department or contract research organisation wishing to conduct clinical research anywhere in Europe.

 

Update of the Report, as of 2012

By Question
By Country

Question Index

Websites stated in the report

A word of introduction

What they think of the report

-CRFocus review, by A. Smith, Editor (vol.18, No 3, March 2007)  

-Pharmaceutical Physician, by Dr. Madhu Davies, Editor, (vol.18, No 1, July 2007)

 

Further information:

A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU - Master of Drug Regulatory Affairs by Ralf Rickert (2009)

In this master thesis the current differences and similarities between the EC procedures in Europe that were shown by the EFGCP Report have been further investigated in a multi-stage approach. The EFGCP report (last updated April 2009) has served as a starting point for the examinations. Based on its findings, the requirements for EC applications in the different countries have been compared and further analysed. Differences and similarities were highlighted while focussing on characteristics relevant to assess the (expected) level of complexity of the respective ethical review procedures in the countries.


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