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BY-NC-ND 3.0 license Open Access Published by De Gruyter October 29, 2008

Laboratory testing in clinical trials under consideration of the ICH-GCP guideline1

  • Stephan Nordmann and Eberhard Wieland

Abstract

Clinical trials are a prerequisite for the launch and registration of new drugs. During recent years the regulations have become more strict worldwide including Germany. The German law governing the manufacture and prescription of drugs (German Drugs Act, AMG) has adopted the contents of the guideline for Good Clinical Practice (GCP) which was harmonised by the International Conference on Harmonisation (ICH) and makes binding recommendations with respect to ethics and quality of clinical trials. Since laboratory investigations form an integral part of most clinical trials it is beyond doubt that these recommendations and laws do also apply to laboratory testing. In consideration of these rules it is a demand that laboratories and laboratory physicians be involved early in the planning of clinical trials. In addition, laboratories must be informed of ongoing trials before they are initiated in a trial site of a hospital. Optimally, a separate laboratory contract has been signed and laboratory testing is reimbursed according to the German fee regulations for physicians (GOÄ). In the authors' opinion, the dissemination of proficiency testing documents and reference values to the sponsor after a trial has been completed is insufficient to fulfil legal requirements and to comprehensively exclude legal liability of the laboratory personnel.


Correspondence: Stephan Nordmann, Zentralinstitut für Klinische Chemie und Laboratoriumsmedizin, Klinikum Stuttgart, Kriegsbergstrasse 60, D-70174 Stuttgart, Germany Tel.: +49-0711-278-4801 Fax: +49-0711-278-4809

Published Online: 2008-10-29
Published in Print: 2008-09-01

©2008 by Walter de Gruyter Berlin New York

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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