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Journal of Long-Term Effects of Medical Implants
SJR: 0.332 SNIP: 0.491 CiteScore™: 0.89

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v19.i3.70
pages 215-222

Surviving a Site Audit: Tips for Good Clinical Practice in an Implant Trial

Esther M.M. Van Lieshout
Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam 3000 CA, The Netherlands
Stephanie M. Zielinski
Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam 3000 CA, The Netherlands

ABSTRACT

The number of clinical trials involving implants for trauma and orthopedic surgery is increasing. The International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guideline has been developed in order to assure that the rights, safety, and well-being of trial subjects (i.e., patients) are protected. Not performing a trial according to legal requirements including this guideline is no longer acceptable, and trial audits are increasingly being performed as an independent quality check for data validity and credibility. This manuscript provides an overview of the guideline for Good Clinical Practice (GCP) in the context of conducting an implant trial in trauma and orthopedic surgery. As long as all guidelines are adequately adhered to and all paperwork is in order, there is no reason to fear a trial audit.