Note: This training is offered online by CITI

CITI Course Name

IRB GCP for Clinical Trials with Investigational Drugs and Medical Devices (FDA Focus)
Course Background

This course is designed specifically for clinical researchers participating in human subjects research to have an understanding and knowledge of the federal regulations, International Council for Harmonisation (ICH) Regulations, and Good Clinical Practice guidelines that apply to clinical research.

Required Modules
  1. The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices
  2. Informed Consent in Clinical Trials of Drugs, Biologics, and Devices
  3. Overview of New Drug Development
  4. Overview of ICH GCP
  5. ICH - Comparison Between ICH GCP E6 and U.S. FDA Regulations
  6. Conducting Investigator-Initiated Studies According to FDA Regulations and GCP
  7. Investigator Obligations in FDA-Regulated Clinical Research
  8. Managing Investigational Agents According to GCP Requirements
  9. Overview of U.S. FDA Regulations for Medical Devices
  10. Detecting and Evaluating Adverse Events
  11. Reporting Serious Adverse Events
  12. Audits and Inspections of Clinical Trials
  13. Monitoring of Clinical Trials by Industry Sponsors
  14. Completing the CITI GCP Course
Passing Score

Learners must 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 4 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)
  • Phase I Research: Understanding Phase I Research
  • Phase I Research: Protecting Phase I Subjects 
  • Overview of the Clinical Trial Agreement (CTA)
  • Understanding the Terms of the Clinical Trial Agreement
  • Role of the Researcher and Site in Managing the Clinical Trial Agreement (CTA)
  • Clinical Trial Agreement (CTA) Negotiation for Researchers and Sites