Medical Device GCP – Investigator Certificate (v3)
Medical Device GCP – Investigator Certificate (v3)
This indispensable 6 part course provides Investigators and clinical investigation site personnel with a comprehensive introduction to the medical device Good Clinical Practice environment and offers an in-depth look at the criteria every investigator should consider before making the decision to participate in a medical device clinical investigation.
You will learn what the ethical and legal requirements are, how to ensure a successful initiation of the investigation and how to collaborate effectively with the sponsor during the investigation as well as the requirements of closing down a clinical investigation.
The courses have been developed according to the requirements outlined in:
ISO 14155:2026 – Clinical Investigation of medical devices for human subjects – Good clinical practice
21 CRF part 812 – Investigational device exemption
Declaration of Helsinki
21 CRF part 50 – Protection of Human Subjects
ID: 187
201 minutes
6 trainings
| Course | ID | Duration | |
|---|---|---|---|
GCP for Investigators: Introduction to Medical Devices (v3) |
193 | 40 minutes | |
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations (v3) |
200 | 30 minutes | |
GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations (v3) |
212 | 28 minutes | |
GCP for Investigators: Initiation of the Clinical Investigation (v3) |
202 | 30 minutes | |
GCP for Investigators: Clinical Investigation Conduct and Reporting (v3) |
204 | 49 minutes | |
GCP for Investigators: Clinical Investigation Close out or termination (v3) |
206 | 24 minutes |
Learning Objectives:
Upon completion of this course, trainees will be able to correctly and successfully:
· Recognize the differences in conducting medical device clinical investigations versus pharmaceutical trials
· Make sound decisions as to whether or not to participate in a clinical investigation based on essential criteria
· Prepare, conduct and close a clinical investigation in an efficient manner in compliance with the regulations.
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.
General Requirements for WMDO Courses
- Course Access Duration: Each course is available for 60 days from the date of assignment.
- Quiz Completion: Users are allowed 2 attempts to complete each quiz, with a minimum passing score of 75%.