Skip Navigation LinksHome > July 2005 - Volume 26 - Issue 7 > Good clinical practice: Historical background and key aspect...
Nuclear Medicine Communications:
Symposium on Good Clinical Practice

Good clinical practice: Historical background and key aspects

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

Collapse Box


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.

© 2005 Lippincott Williams & Wilkins, Inc.


Article Tools


Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.