GCP for Investigators: Clinical Investigation Close out or Termination

This course examines the circumstances in which a clinical investigation may need to be suspended or prematurely terminated and the role of each party involved. It outlines all major activities required to close clinical investigations, including mandatory reporting to sponsors, ethics committees, institutional review boards, competent authorities, or the FDA.

The content of this course is based on:

• ISO 14155: 2011: 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