Good clinical practice: Historical background and key aspects

被引：27

作者：

Otte, A

Maier-Lenz, H

Dierckx, RA

机构：

[1] State Univ Ghent Hosp, Div Nucl Med, B-9000 Ghent, Belgium

[2] Univ Hosp Freiburg, Ctr Clin Trials, Freiburg, Germany

[3] Univ Groningen Hosp, Dept Nucl Med & Mol Imaging, Groningen, Netherlands

来源：

NUCLEAR MEDICINE COMMUNICATIONS | 2005年 / 26卷 / 07期

关键词：

good clinical practice (GCP); Food and Drug Administration (FDA); Declaration of Helsinki; Council for International Organizations of Medical Sciences (CIOMS); International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; (ICH); European Medicines Evaluation Agency (EMEA); EU Clinical Trial Directive;

D O I：

10.1097/01.mnm.0000168408.03133.e3

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

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.

引用

页码：563 / 574

页数：12