Note: This training is offered online by CITI

CITI Course Name

IRB GCP for Clinical Investigations of Devices
Course Background

This course is designed specifically for clinical researchers participating in human subjects research to gain an understanding and knowledge of the U.S. federal regulations, International Organization for Standardization (ISO) 14155:2011 principles, and Good Clinical Practice guidelines that apply to clinical research.
Required Modules
  1. The CITI Good Clinical Practice Course for Clinical Investigations of Devices 
  2. Conducting Investigator-Initiated Clinical Investigations of Devices
  3. Investigator Obligations in FDA-Regulated Clinical Investigations of Devices
  4. Managing Investigational Devices According to GCP Requirements
  5. Overview of U.S. FDA Regulations for Investigational Devices
  6. Informed Consent in Clinical Investigations of Devices
  7. Monitoring Clinical Investigations of Devices
  8. Audits and Inspections of Clinical Investigations of Devices
  9. Reporting Requirements for Clinical Investigations of Devices
  10. Completing the CITI Program’s GCP Course for Clinical Investigations of Devices
Passing Score

Learnersmust take a short quiz at the end of each module. An average score of 80% is needed to pass the training.
IRB Prerequisite Researchers working on a clinical trial must take a relevant Good Clinical Practice course in additionto a foundational human subjects research course. 
Valid for  5 Years
Duration About 3 hours
Supplemental Modules

The IRB encourages learners to take optional modules based on their area of study and research methods. The following courses are available: 

  • Humanitarian Use Devices (HUDs)
  • Overview of the Clinical Trial Agreement (CTA)
  • Understanding the Terms of the Clinical Trial Agreement (CTA)
  • Role of the Researcher and Site in Managing the Clinical Trial Agreement (CTA)
  • Clinical Trial Agreement (CTA) Negotiation for Researchers and Sites