The GCP Device Basic course is intended for research personnel involved in investigations of devices. It includes FDA regulations and guidance as well as International Organization for Standardization Guidelines ISO 14155:2020.
It also provides an overview of investigator obligations in conducting clinical investigations of devices, as well as managing investigational devices according to GCP requirements, monitoring, audits and inspections, and informed consent for clinical investigations.
Language Availability: Chinese, English, Finnish, French, German, Korean, Spanish
Suggested Audiences: Clinical Research Coordinators, Contract Research Organizations (CROs), Investigators, Key Study Personnel, Research Nurses, Research Staff, Research Staff who are Involved in the Design and Conduct of Clinical Trials with Devices, Research Staff who are Involved in the Oversight or Management of Clinical Trials with Devices, Research Teams, Sponsors
Organizational Subscription Price: Included in Good Clinical Practice (GCP) series for $1,000 per year/per site
Independent Learner Price: $129 per person