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Good clinical practice.

Authors
  • Regnier, B
Type
Published Article
Journal
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
Publication Date
Jul 01, 1990
Volume
9
Issue
7
Pages
519–522
Identifiers
PMID: 2226484
Source
Medline
License
Unknown

Abstract

Good Clinical Practice (GCP) is a quality assurance system dealing with all stages of clinical trials which is progressively being adopted by European countries. European GCP guidelines are in preparation and will be issued soon. However, implementation of the guidelines poses major and costly problems. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspections are among the most difficult issues. The obvious benefits of GCP are the improved quality of clinical trials and of data generated by such trials, as well as mutual recognition of studies conducted abroad.

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