GCP for Investigators: Clinical Investigation Conduct and Reporting

This course reviews important elements for conducting clinical investigations.

It covers the following topics:

• Effective team–sponsor communication to ensure compliance
• Investigator involvement during monitoring visits
• The informed consent process
• The device accountability process
• Data and other study-related requirements
• Reporting

The content of is 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