ISO 14155:2020 - Clinical Investigation Conduct

This course describes the conduct and activities at the beginning and throughout the course of clinical investigations in accordance with ISO 14155. 

 This course covers the following topics:

• Initiation visits
• Site monitoring
• Adverse event and device deficiency reporting
• Documents, documentation, and data control
• Electronic system requirements
• Auditing requirements
• Training new site personnel
• Guaranteeing subjects’ privacy and confidentiality
• Accounting for all subjects