Medical Device GCP for Investigators
Medical Device GCP for Investigators
This program provides investigators and clinical investigation site personnel with a comprehensive introduction to the medical device regulatory environment. It offers an in-depth look at the criteria every investigator should consider before deciding to participate in a medical device clinical investigation.
It covers the following topics:
- Ethical and legal requirements of medical device clinical investigations
- How to ensure a successful investigation initiation
- Effective collaboration with sponsors during investigations
- Requirements for closing down clinical investigations
The content of this program is based on:
- ISO 14155: 2011: Clinical Investigation of Medical Devices for Human Subjects
- The Declaration of Helsinki
- 21 CFR 812: Investigational Device Exemption
- 21 CFR 50: Protection of Human Subjects
ID: 187
213 minutes
6 trainings
| Course | ID | Duration | |
|---|---|---|---|
GCP for Investigators: Introduction to Medical Devices |
193 | 52 minutes | |
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations |
200 | 32 minutes | |
GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations |
212 | 25 minutes | |
GCP for Investigators: Initiation of a Medical Device Clinical Investigation |
202 | 30 minutes | |
GCP for Investigators: Clinical Investigation Conduct and Reporting |
204 | 51 minutes | |
GCP for Investigators: Clinical Investigation Close out or Termination |
206 | 23 minutes |
Learning Objectives
Upon successfully completing this program, learners will be able to:
- Understand the basic medical device regulatory principles for conducting clinical investigations
- Pay special attention to the risk management profiles of investigational devices, which will enable sound decisions prior to and during clinical investigations and ensure patient safety
Who Should Enroll
Principal Investigators, co-investigators, study coordinators and any other key personnel involved in the conduct of a clinical investigation within clinical investigation sites worldwide
Prerequisite Knowledge
Knowing the history of GCP is preferred as understanding why GCP was implemented by the regulators will largely help a more in depth understanding of these further courses. History of GCP is freely available on the WMDO platform and a complimentary course can be taken on a voluntary basis