GCP for Investigators: How to Qualify for Medical Device Clinical Investigations
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations
This course explains the importance of the clinical investigation site qualification process in determining whether a given clinical site has the appropriate resources to conduct an investigation.
The qualification process must provide principal investigators the opportunity to evaluate the scientific value, clinical value, and design of the device in question.
The content of this course is based on:
- ISO 14155: 2020 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
ID: 200
32 minutes
2 modules
Learning Objectives
Upon successfully completing this course, learners will be able to:
- Prepare for and participate in a site qualification visit
- Follow up on post-visit site action items
- Perform regulatory and ethics submissions
Who Should Enroll
Clinical site investigators, study coordinators and nurses, administrators, and those performing clinical investigation activities at clinical sites are all welcome to enroll in this course.
Prerequisite Knowledge
The following course is required:
- GCP for Investigators: Introduction to Medical Devices (ID 193)