| 1 x | Managing Data Release Consent During Post Market Studies | € 75.00 |
| 1 x | Medical Device GCP for Investigators | € 120.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
| 1 x | Understanding Clinical Evaluation for Notified Body and Regulatory Professionals | € 544.00 |
| 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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