GCP for Investigators: How to Qualify for Medical Device Clinical Investigations

This course explains the importance of the clinical investigation site qualification process in determining whether a given clinical site has the appropriate resources to conduct an investigation.

The qualification process must provide principal investigators the opportunity to evaluate the scientific value, clinical value, and design of the device in question.

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