GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations

This course provides a comprehensive outline of the Ethics Committee (EC) or Institutional Review Board (IRB) submission process. It explains logistics for smoother processing and describes in detail how to prepare for the informed consent process; what is important and what constitutes as an essential element.

This course also examines the legal implications of investigator agreements, important facts regarding clinical investigation insurance, and the process for obtaining regulatory approval from competent authorities.

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