| 1 x | Clinical Evaluation Report: Review for Regulatory Professionals | € 308.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations | € 84.00 |
| 1 x | ISO 14155_课程1_范围 | € 143.00 |
| 1 x | test training for stg env | € 12.00 |
| 1 x | second video test | € 9.00 |
| 1 x | 临床试验的启动 | € 95.00 |
| 1 x | 临床试验关闭或终止 | € 66.00 |
| 1 x | US Safety Reporting Requirements during Pre-Market Clinical Trials | € 72.00 |
| 1 x | Duplicate of wmdos-34 | € 20.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or Termination | € 66.00 |
| 1 x | Clinical Evaluation for Market Approval | € 616.00 |
| 1 x | GCP for Investigators: How to Qualify for Medical Device Clinical Investigations | € 95.00 |
| 1 x | GCP for Investigators: Introduction to Medical Devices | € 126.00 |
| 1 x | Managing Data Release Consent During Post Market Studies | € 75.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations
This course explains the importance of the clinical investigation site qualification process in determining whether a given clinical site has the appropriate resources to conduct an investigation.
The qualification process must provide principal investigators the opportunity to evaluate the scientific value, clinical value, and design of the device in question.
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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