Abstract The number of clinical trials involving implants for trauma and orthopedic surgery is increasing. The International Conference of 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 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.

Surgery and Traumatology
Journal of Long-Term Effects of Medical Implants
Includes Accepted Manuscript (19 pp), applying Begell House's NIH policy to EUR
Department of Surgery

van Lieshout, E.M.M, & Zielinski, S.M. (2009). Surviving a Site Audit: Tips for Good Clinical Practice in an Implant Trial. Journal of Long-Term Effects of Medical Implants, 19(3), 215–222. Retrieved from http://hdl.handle.net/1765/25684