| 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 |
GCP for Investigators: Clinical Investigation Close out or Termination
GCP for Investigators: Clinical Investigation Close out or Termination
This course examines the circumstances in which a clinical investigation may need to be suspended or prematurely terminated and the role of each party involved. It outlines all major activities required to close clinical investigations, including mandatory reporting to sponsors, ethics committees, institutional review boards, competent authorities, or the FDA.
The content of this course is based on:
- ISO 14155: 2011: 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
€ 66.00
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