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.