The GCP Device Basic course is intended for research personnel involved in investigations of devices. It includes FDA regulations and guidance as well...
Describes the commitments and obligations assumed by investigators when conducting clinical investigations of devices, including investigator agreemen...
Focuses on specific requirements associated with the management of investigational products by principal investigators, with a specific focus on GCP s...
Provides an overview of the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed...
Explains the reporting requirements of 21 CFR 812, the FDA regulations for the conduct of investigational device studies and ISO 14155. Defines the va...
This module discusses the requirements of the ISO Planning elements, including how to identify environmental aspects and their impacts. Further, the m...
