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Annals of Oncology 2004 15(9):1305-1309; doi:10.1093/annonc/mdh363
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© 2004 European Society for Medical Oncology

The international quality requirements for the conduct of clinical studies and the challenges for study centers to implement them

A. Gajic, R. Herrmann and M. Salzberg*

University Hospital Basel, Clinical Research Oncology, Spitalstrasse 26, CH-4031 Basle, Switzerland

* Email: salzbergm@uhbs.ch

The first 150 words of the full text of this article appear below.

Introduction

In the past 15 years, quality guidelines have been developed for the conduct of clinical research. The Good Clinical Practice Guidelines (GCP) published by the International Conference on Harmonization (ICH) have been implemented and become law in some countries. Based on the GCP, regulatory authorities installed national rules for the conduct of clinical studies. Finally, Standard Operating Procedures (SOP) of Pharmaceutical Companies and Clinical Research Organizations (CRO) describe tactical aspects of clinical research. Those tools resulted in an increase in the quality of clinical studies. However, it is crucial for clinical research centers to implement measures that allow the adherence to those guidelines in order to remain competitive.

Cancer patients are increasingly being treated within clinical studies. Thus, it is of particular interest to oncology clinics to qualify as study centers in order to provide their patients with the latest treatment options, to offer them alternatives, and, last but not . . . [Full Text of this Article]

International ethical principles

International guidelines for the conduct of clinical trials

Regional regulations

USA
European Union
Implication of GCP and Sponsor-SOP on daily clinical research practice


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