Advertisement

Good Clinical Practice

  • Jan Van den Broeck
  • Vundli Ramokolo
  • Jutta Dierkes
Chapter

Abstract

Good Clinical Practice (GCP) is a set of guidelines for trial research, not for the practice of clinical care, as the name might suggest. This chapter aims to introduce the large topic of GCP, to orient those researchers who are unfamiliar with trial research to the essence and scope of GCP guidelines, and to discuss some practical GCP-related tasks. First, the concept of GCP as a standard rooted in general ethical principles and as a new paradigm in experimental research involving human subjects is explained. Next we review the wide scope of GCP-related responsibilities of investigators and discuss the resources required to establish minimum GCP capacity. This leads us to the topic of the relevance of GCP for observational research and implementation difficulties in resource-poor areas. Finally, we introduce in some more detail three selected GCP-related activities that are of particular practical importance during execution of a trial: the maintenance of a regulatory file, adverse events reporting, and site monitoring visits. Basic terminology is listed in Panel 21.1

Keywords

Good Clinical Practice Test Product Adverse Event Report Regulatory File Good Clinical Practice Guideline 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Acosta CJ et al (2007) Implementation of good clinical practice guidelines in vaccine trials in developing countries. Vaccine 25:2852–2857PubMedCrossRefGoogle Scholar
  2. Beauchamps TL, Childress JF (2001) Principles of biomedical ethics, 5th edn. Oxford University Press, Oxford, pp 1–454. ISBN 0195143329Google Scholar
  3. Council for International Organizations of Medical Sciences (2009) International ethical guidelines for epidemiological studies. CIOMS, Geneva, pp 1–128. ISBN 929036081XGoogle Scholar
  4. Department of Health, Republic of South Africa (2006) Guidelines for good practice in the conduct of clinical trials with human participants in South Africa. Department of Health, PretoriaGoogle Scholar
  5. EMA/European Medicines Agency. Good clinical practice guidelines. www.ema.europe.eu. Directive 2005/28/EC. Accessed Feb 2013
  6. National Institutes of Health Office for Extramural Research. Protecting human research participants. http://phrp.nihtraining.com/users/login.php. Accessed Sept 2012
  7. Osrin D et al (2009) Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bull WHO 87:772–779PubMedGoogle Scholar
  8. SATVI. Good clinical practice training courses. http://www.satvi.uct.ac.za/index.php/20101214261/Education-and-training.html. Accessed Sept 2012
  9. World Medical Association. The declaration of Helsinki. http://www.wma.net/en/10home/index.html. Accessed Sept 2012

Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Jan Van den Broeck
    • 1
  • Vundli Ramokolo
    • 2
  • Jutta Dierkes
    • 3
  1. 1.Centre for International Health, Faculty of Medicine and DentistryUniversity of BergenBergenNorway
  2. 2.South African Medical Research CouncilCape TownSouth Africa
  3. 3.Faculty of Medicine and Dentistry, Department of Clinical MedicineUniversity of BergenBergenNorway

Personalised recommendations