A one day course aimed at investigators, project managers, research nurses and other research team members involved in the conduct of medical device research at a clinical research site. It is also relevant to sponsors and device manufacturers involved in conducting clinical investigations. This course includes the following content:
- Medical Devices:
- Types & Classification
- Medical Device Legislation
- Clinical Investigations
- Good Clinical Practice in Device Trials:
- Ethical Issues
- Conduct of a Clinical Investigation
- Safety Reporting in Device Research
Monitoring & Audit
Date: 3rd October 2016 RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital