ISO 14155:2020 - Clinical Investigation Planning

This course describes all activities involved in the clinical investigation planning process.

It covers the following topics:

• Risk assessment
• Justification of the investigational design,
• Clinical Investigation Plan (CIP),  
• Investigator Brochure (IB),
• Case Report Form (CRF) requirements
• Monitoring plan,
• Site selection,
• Investigation agreements,
• Labeling requirements,
• Set up of data monitoring committee.