Good Clinical Practice

  • Jan Van den Broeck
  • Vundli Ramokolo
  • Jutta Dierkes


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


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.


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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

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