GCP for Investigators: Introduction to Medical Devices
Course Description:
This course provides basic and background information on medical device Good Clinical Practice (GCP).
It covers the following topics:
- Overview of essential elements
- Review of the regulatory environment of medical devices in the EU and US
- How the Declaration of Helsinki applies to the medical device field
- Relevant GCP regulatory documents
- Major differences between ICH E6 GCP and medical device GCP as outlined in ISO 14155
- Necessary manufacturing steps for conducting clinical investigations
- Brief review of the elements of medical device study designs
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
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Acquire a working knowledge of the applicable GCP regulatory documents for medical devices
- Comprehend and define the medical device regulatory environment from an objective perspective
- Interpret the different essential documents for medical device clinical investigations
- Contribute to compliance throughout medical device clinical investigation processes
Who Should Enroll:
Principal and co-investigators, study coordinators, site managers, and hospital or ancillary staff involved in the clinical aspects of medical device clinical investigations are all encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following course is required:
- History of Good Clinical Practice (GCP) (41)