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
• Who are on sub-awards, foreign awards, or foreign sub-contracts

The National Institutes of Health (NIH) requires GCP training for NIH-funded investigators and staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials (for the definition of an NIH clinical trial, see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).  The study’s Principal Investigator is responsible for identifying the staff that should take the training.

The policy describes the investigator as the individual responsible for the design and conduct of the clinical trial at a trial site or, if a team of individuals at a trial site are involved, the investigator leading the team.  The policy describes clinical trial staff as those who are responsible for study coordination, data collection, and data management. It provides examples of the activities such individuals may carry out such as participant recruitment and enrollment, including obtaining informed consent, data collection and documentation, and regulatory compliance and reporting.  It notes that clinical trial staff may be referred to variously as a research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

The policy does not apply to those who may consult with the clinical trial team but have no role in the design, conduct, oversight, or management of a clinical trial (e.g., a biostatistician acting as an independent consultant).  Nonetheless, since consultants would likely also benefit from an understanding of GCP principles, they should not be discouraged from taking GCP training.

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.

Yes. If only one aim or a small part of your project meets the NIH definition of a clinical trial, your entire NIH grant application is considered a clinical trial even if the other aims or parts of the research project are not clinical trials. A FOA that allows clinical trials should be chosen, and at least one study record in the application will need to be designated as a clinical trial.

For more on the NIH definition of a clinical trial, visit the Clinical Trials FAQs page.

There are a number of courses available on the CITI website:

• Good Clinical Practice (GCP)
• GCP – Social and Behavioral Research Best Practice for Clinical Research
• GCP – SBR Advanced Refresher
• Buena Práctica Clínica (Módulos en Español)

If you choose to take the GCP course through CITI and have never completed training on GCP, you will want to take the basic GCP course.  When creating a new CITI account or adding a course you will be asked a series of questions on the “Select Curriculum” page.  When answering these questions make sure to select “I have not completed the basic course” for question 3. You will automatically be enrolled in the basic GCP course.

If you have previously completed the Good Clinical Practice Course, you can enroll in the GCP refresher course. When answering question 3 on the "Select Curriculum" page make sure to select which GCP course you have already completed. You will automatically be enrolled in the GCP refresher course.

1. Access the CITI program at https://www.citiprogram.org/
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 “Create a CITI Program Account” button.
4. Enter in your personal information. All fields marked with an asterisk (*) 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. Click “Finalize Registration” button after answering other CITI-specific questions
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 “Submit ” button.
8. Complete all fields that are marked with an asterisk (*) for the “Affiliate with an Institution” section.  For the question “Which course do you plan to take?” select Good Clinical Practice.  Click on the “Next” button.
9. Answer questions 1-14.  Select all options that apply to you and click on the “Submit” button. However, if these options do not apply to you, simply click on the “Submit” button without selecting any of the optional courses.
10. You are now registered and your courses will be listed on the screen.
11. Choose your GCP course and click “Start Now”
12. Click on the agreement for the terms of service. Click on the “Submit” button.
13. All of the required modules for the course will be listed. Click on the “Start” button for the first module to begin the course. Complete all of the required modules. 

1. Access the CITI program at https://www.citiprogram.org/
2. On the “My Courses” screen, under University of California, San Diego locate the section labeled “Learner Tools for University of California, San Diego”. Select the “Add a Course” link.
3. Answer questions 1-14. Select all options that apply to you and click on the “Submit” button.  However, if these options do not apply to you, simply click on the “Submit” button without selecting any of the optional courses.
4. You are now registered and your courses will be listed on the screen.
5. Choose your GCP course and click “Start Now.”
6. Click on the agreement for the terms of service. Click on the “Submit” button.
7. All of the required modules for the course will be listed. Click on the “Start” button for the first module to begin the course. Complete all of the required modules. 

After completing all modules, save a copy of the certificate for your records.