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Journal of Long-Term Effects of Medical Implants

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

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v19.i3.50
pages 201-208

Management Issues Unique to Regulatory Trials

Jacquelyn Marsh
Faculty of Health Sciences, Elborn College, The University of Western Ontario, London, Ontario N6G 1H1, Canada
Dianne Bryant
Faculty of Health Sciences, Elborn College, The University of Western Ontario, London, Ontario N6G 1H1, Canada

ABSTRACT

Regulatory trials provide scientific evidence regarding the effectiveness of medical devices and play a crucial role in the approval to use new devices safely in patient care. Compared to non-regulatory trials, regulatory trials are time intensive and involve strict documentation and protocol regulations. In this article, we outline the unique data management considerations and extensive documentation requirements and provide examples from our own experiences participating in regulatory trials. We provide an overview of the processes involved prior to, during, and after the trial, including what to expect when a monitor visits your site and what to expect if the regulatory body audits your site.