Written Submission on the Operation of the Clinical Trials Directive (directive 2001/20/ec) and Perspectives for the Future

Proposed revisions to the EU clinical trials directive--comments from the European Resuscitation Council.

An editorial written by Fritz Stertz et al. in 2002 and pubished in this journal was one of the first to highlight concerns bout the introduction of a new European Union (EU) clinical trils directive (Clinical Trials Directive 2001/20/EC) particularly for esearch in emergency settings.1 The directive sought “to simplify nd harmonize the administrative provisions governing clinical rials in the ...

Commentary: Can we facilitate the ethical approval of international observational studies?

icinal products for human use. 5 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 6 International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical P...

ENCEPP CONSIDERATIONS ON THE DEFINITION OF NON-INTERVENTIONAL TRIALS UNDER THE CURRENT LEGISLATIVE FRAMEWORK (“CLINICAL TRIALS DIRECTIVE” 2001/20/EC) Agreed by the European Network of Centres for Pharmacoepidemiology

On the Relationship between Emotional Intelligence and Directive Speech Acts Preference

Language and emotion are two related systems in use, in that one system (emotions) impacts the performance of the other (language). Both of them share their functionality in communication. Since the nature of foreign language classrooms is ideally interactional, emotional intelligence (EI) gains importance. The aim of this study was to find out whether one's total emotional quotient and its com...

Comment of the Network of Coordinating Centers for Clinical Trials (KKS-Network), Germany on the Concept Paper Submitted for Public Consultation on 09/02/2011 Revision of the Clinical Trials Directive 2001/20/EC

The KKS-Network, which is the German network of academic clinical trial units, welcomes the Public Consultation Paper of the European Commission concerning the Revision of the Clinical Trials Directive 2001/20/EC. We are grateful to be able to provide input into the current discussion process. Furthermore, we very much appreciate, that the comments of the academic clinical research community wh...