| 1 x | Selecting Investigation Sites | € 161.00 |
| 1 x | Safety Reporting Requirements 2 course Suite v.3 | € 163.00 |
| 1 x | ISO 14155 – Scope of ISO 14155 | € 116.00 |
| 1 x | GCP for Investigators: Initiation of the Clinical Investigation (v3) | € 95.00 |
| 1 x | GCP for Investigators: Introduction to Medical Devices (v3) | € 126.00 |
| 1 x | GCP for Investigators: How to Qualify for Medical Device Clinical Investigations (v3) | € 95.00 |
| 1 x | GCP for Investigators: Clinical Investigation Conduct and Reporting (v3) | € 128.00 |
GCP for Investigators: Clinical Investigation Conduct and Reporting (v3)
GCP for Investigators: Clinical Investigation Conduct and Reporting (v3)
This course reviews important elements for conducting clinical investigations.
It covers the following topics:
- Effective team–sponsor communication to ensure compliance
- Investigator involvement during monitoring visits
- The informed consent process
- The device accountability process
- Data and other study-related requirements
- Reporting
The content of is course is based on:
- ISO 14155: 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
€ 128.00
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