GCP for Investigators: Initiation of a Medical Device Clinical Investigation

This course reviews how investigators and their teams should prepare for initiation visits and actively participate in site initiation activities. It outlines how to organize and implement fully operational investigation sites that are compliant with Clinical Investigation Plans (CIPs), Good Clinical Practices (GCPs), and other applicable regulations.

The content of this course is based on:

• ISO 14155: 2020 Clinical Investigation of Medical Devices for Human Subjects
• The Declaration of Helsinki
• 21 CRF 812: Investigational Device Exemption
• 21 CRF 50: Protection of Human Subjects