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

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.

Project Management of Randomized Clinical Trials: A Narrative Review

“…Finally, achieving ethics approval is often a lengthy process because procedures, documents, and legislation may vary among participating sites in different countries ( 31 ). It is, therefore, recommended to have dedicated and well-trained trial staff to accomplish these administrative tasks ( 32 - 34 ).…”

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

“…Obtaining ethics or Institutional Review Board (IRB) approval is a potential cause of delay, as procedures, documents, and legislation may vary between countries [8]. This process is often time-consuming and it is recommended to have dedicated and well-trained study personnel available to assist participating sites with these administrative tasks [9-13].…”

“…Having adequate support can be more important for sites to decide to participate, than offering a financial compensation for participation [14,15]. The presence of a trial coordinator or assistant will also facilitate an appropriate study infrastructure, which is a requirement for proper study conduct [3,8,16-18]. As community hospitals generally lack such infrastructure, they often cannot participate in multicenter trials.…”