Good Clinical Practice (GCP) FAQs

The NIH GCP training policy is part of a multi-faceted NIH initiative to enhance the quality, relevance, feasibility, efficiency, and transparency of NIH funded clinical trials through stewardship reforms (see Hudson KL, Lauer MS, Collins, FS. Toward a New Era of Trust and Transparency in Clinical Trials. JAMA. 2016; 316(13):1353-1354).

The principles of GCP help assure the safety, integrity, and quality of clinical trials.  GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors.  GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.  NIH applauds institutions that promote even higher standards by requiring their clinical trial investigators to surpass the baseline GCP standard.

The policy applies to all active NIH clinical trials, no matter what point they are in the life cycle of the trial.  The policy also applies to investigators and clinical trial staff:

• Whose clinical trials are exempt from the Common Rule (exempt categories defined in 45 CFR part 101(b));
• Whose names are added on to non-competing progress reports; and,
• Who are on sub-awards, foreign awards, or foreign sub-contracts

The Principal Investigator and Department are responsible for tracking the completion of the Good Clinical Practice training requirements associated with National Institutes of Health (NIH) clinical trials.  Documentation of the training is subject to review by the funding agency and UC San Diego Research Compliance and Integrity (RCI) Office upon request.

The RCI Office facilitates research, innovation and education, responsibly for global excellence and is responsible for broad oversight, resources and education for the integrity and compliance issues relating to the conduct of research.  RCI will work with the various sponsored projects offices to identify the awards that require GCP training.  RCI will conduct monitoring based on the information included in the grant application/proposal.

If you chose to take the GCP course through the CITI and have never completed training on GCP, select the first option on the “Good Clinical Practice (GCP) Course Enrollment” screen.  You will automatically be enrolled in the basic GCP course.

If you have previously completed either the “Good Clinical Practice Course, (US FDA Focus’ course)” or the “GCP Course for Clinical Trials Involving Investigational Drugs (international/ICH focus) course)”, you will want to select the second option on the “Good Clinical Practice (GCP) Course Enrollment” screen.  You will automatically be enrolled in the refresher GCP course.

1. Go to https://about.citiprogram.org/en/homepage/
2. Click on the “Register” button
3. You will need to select the institution that you are affiliated with, in this case, University of California, San Diego. Click on the “Continue” button.
4. Enter in your personal information. All fields marked with an * are required. Click on the “Continue to Step 3” button.
5. Create a username and password, and choose a security question/answer. Click on the “Continue to Step 4” button.
6. CITI asks for your gender, ethnicity and race. Click on the “Continue to Step 5” button.
7. Select whether you want to receive Continuing Education credit (CEUs) for CITI Program course completion and whether CITI can contact you in the future to participate in research surveys. Click on the “Continue to Step 6” button.
8. Complete all fields that are marked with an * in Step 6 for your UC San Diego Profile. Click on the “Continue to Step 7” button.
9. Select the “I am required to complete Good Clinical Practice (GCP) training” Click on the “Next” button.
10. Select the “I am, or expect to become, involved in a funded (i.e. National Institutes of Health (NIH) or other sponsored) clinical trial that requires completion of Good Clinical Practice training. I have never completed training in Good Clinical Practice.  (You will be assigned the “GCP for Clinical Trials with Investigational Drugs and Medical Devices (US FDA Focus)” course.) Click on the “Next” button.
11. You have the option of completing additional GCP courses if your study sponsor requires GCP training with ICH focus, or if you would like additional GCP training involving clinical investigations of devices.  Select all options that apply to you and click on the “Next” button.  However, if these options do not apply to you, simply click on the “Next” button without selecting any of the optional courses.
12. Click on the “Finalize registration” link.
13. On the Main Menu screen, under the “UC San Diego” tab, click on the title of the course to enter the course.
14. Click on the “Complete the Integrity Assurance Statement before beginning the course” link and complete. Click on the “Submit” button.
15. Click on the title of the first module to begin. Complete all of the required modules.
16. After completing all modules, print off a completion form. Keep a copy of the form for your records.

1. Access the CITI program at https://www.citiprogram.org/
2. On the Main Menu screen, under the “UC San Diego” tab, in the “My Learner Tools” for UC San Diego box, select the “Add a Course” link.
3. On the “Select Curriculum – UC San Diego screen, select the “I am required to complete Good Clinical Practice (GCP) training” option.  Click the “Next” button.
4. Select the option that is most appropriate regarding your status with previous GCP training.  Click on the “Next” button.
5. You have the option of completing additional GCP courses if your study sponsor requires GCP training with ICH focus, or if you would like additional GCP training involving clinical investigations of devices.  Select all options that apply to you and click on the “Next” button.  However, if these options do not apply to you, simply click on the “Next” button without selecting any of the optional courses.
6. On the Main Menu screen, under the “UC San Diego” tab, click on the title of the course to enter course.
7. Click on the “Complete the Integrity Assurance Statement before beginning the course” link and complete. Click on the “Submit” button.
8. Click on the title of the first module to begin.  Complete all of the required modules.
9. After completing all modules, print off a completion form.  Keep a copy of the form for your records.

You can view and print a copy of your completion certificate by logging into the CITI home page.  At the “Learner's Menu” screen, if the Status heading says:

• “Passed”:  click on the PRINT link under Completion Reports.  This will display a table. Click “Print Completion Report” to print the certificate. 
• “Not Started - Enter” or “Incomplete - Re-enter:” click on Previous Coursework Completed link, and then click on See Coursework Completed.  When the table is displayed, click on the “Print Completion Report” link.