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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 Charité – Universitätsmedizin Berlin retains responsibility for clinical trials of medicinal products for human use for which applications were submitted to the Ethics Committee of Charité – Universitätsmedizin 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
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.