This indispensable 6 course suite provides Investigators and clinical investigation site personnel with a comprehensive introduction to the medical device regulatory 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 part of this Suite have been developed according to the requirements outlined in:
ISO 14155:2011 – 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
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.
|Course Title Click on a title to view course description||ID||Duration|
|GCP for Investigators: Introduction to Medical Devices||46||52|
|GCP for Investigators: How to Qualify for Medical Device Clinical Investigations||47||32|
|GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations||48||25|
|GCP for Investigators: Initiation of a Medical Device Clinical Investigation||49||30|
|GCP for Investigators: Clinical Investigation Conduct and Reporting||50||51|
|GCP for Investigators: Clinical Investigation Close out or Termination||51||23|