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Journal of Laboratory Medicine

Official Journal of the German Society of Clinical Chemistry and Laboratory Medicine

Editor-in-Chief: Schuff-Werner, Peter

Ed. by Ahmad-Nejad, Parviz / Bidlingmaier, Martin / Bietenbeck, Andreas / Conrad, Karsten / Findeisen, Peter / Fraunberger, Peter / Ghebremedhin, Beniam / Holdenrieder, Stefan / Kiehntopf, Michael / Klein, Hanns-Georg / Kohse, Klaus P. / Kratzsch, Jürgen / Luppa, Peter B. / Meyer, Alexander von / Nebe, Carl Thomas / Orth, Matthias / Röhrig-Herzog, Gabriele / Sack, Ulrich / Steimer, Werner / Weber, Thomas / Wieland, Eberhard / Winter, Christof / Zettl, Uwe K.


IMPACT FACTOR 2018: 0.389

CiteScore 2018: 0.22

SCImago Journal Rank (SJR) 2018: 0.156
Source Normalized Impact per Paper (SNIP) 2018: 0.089

Online
ISSN
2567-9449
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Volume 32, Issue 5

Issues

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

Stephan Nordmann
  • 1Zentralinstitut für Klinische Chemie und Laboratoriumsmedizin im Zentrum für Klinische Pathologie, Pharmazie und Hygiene [Central Institute of Clinical Chemistry and Laboratory Medicine at the Centre of Clinical Pathology, Pharmaceutics and Hygiene] (Medical Director Prof. Dr. med. E. Wieland), Medical Centre Stuttgart, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Eberhard Wieland
  • 2Zentralinstitut für Klinische Chemie und Laboratoriumsmedizin im Zentrum für Klinische Pathologie, Pharmazie und Hygiene [Central Institute of Clinical Chemistry and Laboratory Medicine at the Centre of Clinical Pathology, Pharmaceutics and Hygiene] (Medical Director Prof. Dr. med. E. Wieland), Medical Centre Stuttgart, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2008-10-29 | DOI: https://doi.org/10.1515/JLM.2008.051et

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.

Keywords: clinical trials; German law governing the manufacture and prescription of drug; German drugs act; ICH-GCP guideline; laboratory testing; legal rules

About the article

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


Citation Information: LaboratoriumsMedizin, Volume 32, Issue 5, Pages -–-, ISSN (Online) 1439-0477, ISSN (Print) 0342-3026, DOI: https://doi.org/10.1515/JLM.2008.051et.

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