| 1 x | ISO 14155:2020 - Responsibilities of Principal Investigator | € 125.00 |
| 1 x | Introduction to Medical Device and Clinical Investigation Planning | € 161.00 |
| 1 x | Introduction to Good Clinical Practice | € 109.00 |
| 1 x | Deviations and Non-Compliance Handling | € 54.00 |
| 1 x | The Periodic Monitoring Visit | € 429.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Planning | € 180.00 |
ISO 14155:2020 - Clinical Investigation Planning
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.
2 modules
€ 180.00
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