Note: This training is offered online by CITI

CITI Course Name

IRB GCP for Clinical Trials with Investigational Drugs and Biologics (ICH 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. This course is designed for clinical trials involving drugs and biologics. For the purpose of these modules, the term "drug" is intended to include both drugs and biologics.

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

  • 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 (CTA)
  • Role of the Researcher and Site in Managing the Clinical Trial Agreement (CTA)
  • Clinical Trial Agreement (CTA) Negotiation for Researchers and Sites