GCP training is required for research personnel in studies involving Investigational New Drugs; Significant Risk and Non-Significant Risk Devices; and/or that meet the NIH Definition of Clinical Trial. In accordance with NIH's Policy, research personnel on NIH-funded clinical trials must renew GCP training every 3 years.
Instructions for Biomedical GCP Training
1. Visit https://www.citiprogram.org/ and click “Register"
- If you already have a CITI account through another institution, you must add an affiliation with The University of Texas at Arlington to be able to access the courses. Follow the instructions for adding an affiliation.
2. During registration, select your curriculum:
- In "Question 1 Human Subject Research" select the option "Biomedical Research Investigators"
- In "Question 2 Institutional Official/IRB Chair" do not select an option (leave blank)
- In "Question 3 Good Clinical Practice" select the option "Good Clinical Practice Course, US FDA Focus"
3. Open the course "Biomedical Research" and complete the following module:
- FDA-Regulated Research (ID: 12)
4. Open the course "GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)" and complete the following modules:
- Overview of ICH GCP (ID: 1352)
- Conducting Investigator Initiated Studies According to FDA Regulations and GCP (ID: 1355)
- Investigator Obligations in FDA-Regulated Research (ID: 1356)
- Managing Investigational Agents According to GCP Requirements (ID: 1357)
- Detecting and Evaluating Adverse Events (ID 1360)
- Reporting Serious Adverse Events (ID: 1361)
- Audits and Inspections of Clinical Trials (ID 1363)
- Overview of U.S. FDA Regulations for Medical Devices (ID: 1358)
- The remaining modules are recommended, but optional.
Instructions for Behavioral/Social Science GCP Training
1. Visit the Society of Behavioral Medicine GCP Course
2. Click the option for Non-Members, "Create a login." An account Setup will be emailed to you to complete the login process.
3. Click on the course "Good Clinical Practice (GCP) for Social and Behavioral Research - eLearning Course"
4. Complete the nine video modules.
5. Upon completion, save a copy of your certificate to provide to NIH and/or the IRB upon request.