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Good clinical practice: Historical background and key aspects

Otte, Andreasa; Maier-Lenz, Herbertb; Dierckx, Rudi A.c

Nuclear Medicine Communications: July 2005 - Volume 26 - Issue 7 - pp 563-574
Symposium on Good Clinical Practice

Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver–Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

aDivision of Nuclear Medicine, Ghent University Hospital, Belgium

bCenter of Clinical Trials, University Hospital Freiburg, Germany

cDepartment of Nuclear Medicine and Molecular Imaging, Groningen University Hospital, The Netherlands

Correspondence to Prof. Dr. Andreas Otte, Division of Nuclear Medicine, Ghent University Hospital, De Pintelaan 185, B-9000 Gent, Belgium

Tel: +32 9 240 3028; fax: +32 9 240 3807;

e-mail: Andreas.Otte@Ugent.be

Received 1 March 2005 Accepted 12 April 2005

© 2005 Lippincott Williams & Wilkins, Inc.