B. Clinical trials of medicines for human use falling under the unrevised AMG...

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...with continued oversight by the Ethics Committee of Charité – Universitätsmedizin Berlin and the Berlin Chamber of Physicians.

I. The Ethics Committee of CharitéUniversitätsmedizin Berlin retains responsibility for clinical trials of medicinal products for human use for which applications were submitted to the Ethics Committee of CharitéUniversitätsmedizin Berlin and the Berlin Chamber of Physicians prior to 6 August 2004, and whose applications were accompanied by all of the documents required under section 40, subsection 1.2 of the unrevised AMG, which was valid until 6 August 2004.

Ethics Committee mailing address:

Charité - Universitätsmedizin Berlin
Ethikkommission
Geschäftstelle
Charitéplatz 1
10117 Berlin

For assistance with the planning and/or conduct of a clinical trial, please contact  Charité's Coordinating Center for Clinical Studies (KKS Charité).

Under the Clinical Trials Directive 2001/20/EC, a clinical trial of a medicinal product is defined as follows:
'clinical trial': any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s), and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State.

According to Article 2d) of the above-named directive, an 'investigational medicinal product' is defined as being a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.