FAQs for Good Clinical Practice training (GCP)

Good Clinical Practice training (GCP)

  1. Do I have to complete this training?
  2. Where do I go to take this training?
  3. I’ve never used the CITI website before.  How do I create a new account on the CITI website for the University of Iowa and register for a GCP course?
  4. How do I add a GCP course if I’m already a registered user that is affiliated with the UI?
  5. How do I know which GCP course I should take?
  6. Will I be notified when my GCP training is about to expire?
  7. Who is responsible for keeping track of my GCP certification?
  8. What if I my study is not funded by the NIH but by a different sponsor? What are their requirements?
  9. Does my GCP certification expire even if I do not have NIH funding?

1. Do I have to complete this training?

Unlike human subjects research training, not everyone needs to complete GCP training at the University of Iowa even though they may have contact or interactions with research subjects or with their private, identifiable information.  The requirement to complete this training is usually determined by your funding source.  All investigators and staff who are involved in the conduct, oversight or management of NIH funded clinical trials are required to complete training in Good Clinical Practice (GCP) and refresh this training every 3 years, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2) .  Information on this training requirement can be found here.  The University of Iowa will require GCP training to be completed by all researchers involved in the conduct, oversight, or management of NIH funded clinical trials no later than 12/31/17. 

*NIH may require those with NIH funded studies to complete the GCP training prior to this date.  In the event this occurs, the UI will defer to their requirement.  Other sponsors may also require this training; you will need to check with the sponsor to see if they have specific GCP training requirements.

2. Where do I go to take this training?

Investigators at the University of Iowa that are required to complete GCP training can complete an education program through the Collaborative Institutional Training Initiative program (CITI). 

3. I’ve never used the CITI website before.  How do I create a new account on the CITI website for the University of Iowa and register for a GCP course?

  1. Go to citiprogram.
  2. Click on the ’Register’ button under ‘Create an account’
  3. You will need to select the institution that you are affiliated with, in this case, the University of Iowa. In the ‘Select Your Organization Affiliation’ section type in ‘University of Iowa’. Click on the ‘Continue to Step 2’ 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. We encourage you to use your HawkID as your username, if it is available. Do not use your HawkID password as your CITI password. Choose something that is easy for you to remember but is not your HawkID password. [NOTE: Your HawkID is NOT your University of Iowa Employee Number or student ID Number. You can obtain your HawkID from your listing in the UI online directory.] Click on the ‘Continue to Step 4’ button.
  6. CITI asks for your gender, ethnicity and race. If you have questions about why this information is collected by this site, please refer to the CITI website. 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 University of Iowa Profile. In the very last field, please enter your HawkID to receive course credit if you are a UI faculty, staff or student. Click on the ‘Continue to Step 7’ button.
  9. Select the ‘I am required to complete Good Clinical Practices (GCP) training’ option. Click on the ‘Next’ button.
  10. Select the ‘I am, or expect to become, involved in a funded (i.e. 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.)’ option.  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 ‘University of Iowa Courses’ 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.
  16. Complete all of the required modules.
  17. Use the "Main Menu | FAQ | Logoff" links at the top of the page as needed.
  18. After completing all modules, print off a completion form. Keep a copy of the form for your records. The HSO will automatically be notified of your completion of the course. Please allow 1 to 2 business days after you complete the course for this information to be entered into the Certified Investigator Database.

4. How do I add a GCP course if I’m already a registered user that is affiliated with the UI?

  1. Re-enter the CITI program at https://www.citiprogram.org/
  2. On the Main Menu screen, under the ‘University of Iowa Courses’ tab, in the ‘My Learner Tools for University of Iowa’ box, select the ‘Add a Course’ link.
  3. On the ‘Select Curriculum – University of Iowa’ screen, select the ‘I am required to complete Good Clinical Practices (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 ‘University of Iowa Courses’ 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.
  9. Complete all of the required modules.
  10. After completing all modules, print off a completion form. Keep a copy of the form for your records. The HSO will automatically be notified of your completion of the course. Please allow 1 to 2 business days after you complete the course for this information to be entered into the Certified Investigator Database.

5. How do I know which GCP course I should take?

If you have never completed training in Good Clinical Practice, you will want to 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.

6. Will I be notified when my GCP training is about to expire?

You will receive automated reminder emails from 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 either CITI or the HSO.

7. Who is responsible for keeping track of my GCP certification?

The HSO does not keep copies of individual CITI program course completion records.  Entry of certifications into the Certified Investigator’s database is the only record that the HSO maintains for CITI program course completions.   It is the responsibility of the individual to maintain a record of their own GCP certification.

8. What if I my study is not funded by the 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 GCP training.

9. Does my GCP certification expire even if I do not have NIH funding?

Yes.  Due to programming constraints within the CITI website, there is no way to distinguish learners who are completing GCP training for an NIH funded study from those that are completing GCP training for a different sponsor that may not require GCP training to be renewed every 3 years.   Even if your sponsor does not require renewal, you may still receive the automated email reminders from CITI that your GCP training will expire soon.  It is the responsibility of the individual to ensure that they are compliant with their sponsor’s requirements.