| 1 x | Effective Monitoring of Medical Device Clinical Investigations | € 1’517.00 |
| 1 x | Introduction to Medical Device and Clinical Investigation Planning | € 161.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
| 1 x | Adverse Event Processes | € 275.00 |
| 1 x | ISO 14155:2020 - Scope | € 143.00 |
| 1 x | GCP for Investigators: Initiation of a Medical Device Clinical Investigation | € 95.00 |
GCP for Investigators: Initiation of a Medical Device Clinical Investigation
GCP for Investigators: Initiation of a Medical Device Clinical Investigation
This course reviews how investigators and their teams should prepare for initiation visits and actively participate in site initiation activities. It outlines how to organize and implement fully operational investigation sites that are compliant with Clinical Investigation Plans (CIPs), Good Clinical Practices (GCPs), and other applicable regulations.
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
2 modules
€ 95.00
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