| 1 x | The Close Down Visit | € 108.00 |
| 1 x | Applying GDPR to Medical Devices Clinical Investigations | € 124.00 |
| 1 x | ISO 14155 - Risk Management | € 148.00 |
| 1 x | ISO 14155 - Ethical Condiseration | € 112.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations (v3) | € 84.00 |
| 1 x | Overview of Data Management Plan and Query Process | € 81.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or termination (v3) | € 66.00 |
| 1 x | The Periodic Monitoring Visit | € 429.00 |
The Periodic Monitoring Visit
The Periodic Monitoring Visit
This course provides an in-depth review of the activities related to monitoring clinical investigations after initiation. The course includes numerous practical examples based on real-life situations that monitors can encounter during ongoing monitoring activities of medical device clinical investigations.
It covers the following topics:
- Preparing for visits whether onsite or remote
- Planning and confirming visits
- Case studies of handling deviations, personnel changes, or changes in resources
- Ensuring accurate reporting of data, including safety data
- Reporting findings during visits
- Following up on actions required by site personnel
2 modules
€ 429.00
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