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Good Clinical Practice (GCP) FAQs

Answers to frequently asked questions about Good Clinical Practice (GCP) training requirements

Why did National Institutes of Health (NIH) issue the Good Clinical Practice (GCP) training policy?

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.

When did the National Institutes of Health (NIH) Good Clinical Practice (GCP) policy go into effect?

As of January 1, 2017, all NIH-funded investigators and staff who are involved in the design, conduct, oversight, or management of clinical trials, must be trained in GCP.

Does the Good Clinical Practice (GCP) policy apply to National Institutes of Health (NIH) clinical trials awarded before the January 1, 2017 effective date?

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

Who needs to take the Good Clinical Practice (GCP) training?

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.

Is Good Clinical Practice (GCP) training different from the Human Subjects CITI training that is required?

Yes, please note that GCP training is separate from human subjects training required for Institutional Review Board (IRB) submissions.

When does the training need to be completed?

All responsible parties should complete their Good Clinical Practice (GCP) training before their involvement in the clinical trial.

What if I my study is not funded by the National Institutes of Health (NIH) but by a different sponsor? What are their requirements?

If your study is not funded by the NIH, but by another sponsor, you will need to check with the sponsor to see what their requirements are for Good Clinical Practice (GCP) training.

Who is responsible to ensure the training has been completed?

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.

What options are there for Good Clinical Practice (GCP) training?

UC San Diego Investigators and staff that are required to complete GCP training can complete an online course through the Collaborative Institutional Training Initiative program (CITI).  There is no cost for this course.  There are other, free of charge GCP training courses sponsored by NIAID and NIDA. In addition, NCATS has developed a GCP training program geared to behavioral clinical trial investigators.

What if I already completed Good Clinical Practice (GCP) training through an entity other than CITI (e.g. National Institutes of Health GCP training, FDA GCP training, etc.)?

There is no specific requirement on which GCP course that must be completed. You must retain documentation of the training (e.g., a certificate of completion) as proof of GCP training completion and provide the certificate if requested by your funding agency or Research Compliance and Integrity (RCI) Office.

If Good Clinical Practice (GCP) training occurs outside of Collaborative Institutional Training Initiative (CITI), how and where will it be tracked?

You can receive GCP training from anywhere; just remember to retain documentation of the training to provide to the funding agency and the UC San Diego Research Compliance and Integrity (RCI) Office upon request.

What Collaborative Institutional Training Initiative (CITI) modules are available?

There are a number of modules available on the CITI website: (1) CITI Good Clinical Practice Course (ID: 30156), (2) GCP – Social and Behavioral Research Best Practice for Clinical Research (ID: 153898) and (3) Buenas Practicas Clínicas (Módulos en Español) (ID: 59514).

How do I know which Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) course I should take?

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.

I have never used the Collaborative Institutional Training Initiative (CITI) Program before. How do I create a new account on the CITI website for UC San Diego and register for a Good Clinical Practice (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.

How do I add the Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) course if I am already a registered user that is affiliated with UC San Diego?

  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.

Does my Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) certification expire?

Yes, the CITI GCP certification expires after 3 years. To renew the GCP certificate take the GCP Refresher course.

If I completed the CITI Good Clinical Practice (GCP) training, will I be notified when my GCP training is about to expire?

You will receive automated reminder emails from Collaborative Institutional Training Initiative (CITI) prior to the expiration date of your GCP certification. These will be sent out at 90 days, 30 days and 7 days prior to the expiration date of the last completed stage. If your certification expires, you will NOT receive any additional notification from CITI.

Do I need to complete the Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) training it all at once?

You can leave and go back to the training by logging back in as often as necessary. All training completed will be stored in the CITI system.

How do I access my Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) certificate of completion?

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.

Is there a GCP module that is for a clinical trial that is not a drug trial or concentrated on FDA regulations?

Yes, The National Institutes of Health (NIH) have released a  Good Clinical Practice for Social and Behavioral Research eLearning Course. This course meets the NIH requirements for GCP training and can be found here.
These FAQ were adapted from the National Institutes of Health (NIH) FAQ regarding GCP and Stanford University GCP FAQ