All Key Study Personnel at UCSF or its affiliated institutions must complete human subjects protection training on the Collaborative Institutional Training Initiative (CITI) website. The requirement to complete CITI training applies to all Human Subjects Research, Key Study Personnel, including: Exempt, Expedited and Full Board studies. IRB approval of any individual application is contingent upon the fulfillment of this requirement.
include the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the course of the research.
Key Personnel also include faculty mentors/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
CITI human subjects protection training is only mandatory for KSP. However, we recommend that anyone involved with human subjects complete CITI training or similar human subjects protection training. IRB members, HRPP staff and Institutional Officials also must complete CITI training.
Note: If you are a SFVAMC researcher, you do not need to complete the UCSF course.
How to Register on CITI
On the CITI site, click the Register button. In Step 1, type in University of California, San Francisco as your organization affiliation.
In Step 2, enter your name and email address.
Your UCSF or SFVAMC CITI training record is linked to your account in iRIS, the IRB’s online submission system. The two accounts are linked by email address, so your PRIMARY email address in CITI must match your email address in iRIS. If necessary, you can update your email address in CITI or in the "My Account Information" section of iRIS under "My Assistant."
In steps 3-6, enter a user name, password, security question and personal profile info. You also can choose to receive Continuing Education credits, which are available for a fee that is paid by the learner. You only need to answer the required questions in these sections.
Note: Individuals who are not employed by UCSF can complete the training if their institution does not offer human subjects training.
You will be given three curriculum options. Some are required, some optional.
- "Human Subjects Protection Training" is required for all studies seeking IRB approval.
- "Good Clinical Practice (GCP)" is required for all NIH-funded studies seeking IRB review. It is optional for non-NIH-funded studies. Note: The IRB will soon require GCP training for all study personnel regardless of funding.
- "Responsible Conduct in Research (RCR)" is optional for the IRB. However, some federal awards require that grantees undergo education in the responsible conduct of research. To meet this requirement, researchers should register and complete the CTSI RCR Course.
FAQs: Completing the UCSF CITI Human Subjects Protection Training Course
- You will be required to take 4 core modules and 2 modules of your choosing. You can take additional optional modules on other topics, if you wish.
- NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP). Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.
Most users complete all of their required modules in 2-4 hours. You can stop and begin anytime. Save your work before you exit, and remember your user name and password.
After you finish the course, CITI will issue a completion report. Keep a copy for your records and give a copy to members of your administrative team who need it for their records.
The IRB will be able to confirm that you have taken the training. The Office of Sponsored Research also can confirm your training by looking online.
The UCSF CITI Human Subjects Protection Training course is valid for 3 years. You can renew your training easily by taking any 3 modules of your choosing. You will receive email reminders from CITI prior to expiration, but also keep track of your training expiration date.
SFVAMC CITI training and the optional UCSF GCP training also are valid for 3 years.
Completing a Refresher Course
After you log into CITI, the Human Subjects Protection Training refresher course (e.g. Stage 2, 3 or 4) will appear in the UCSF courses section. Click on the title of the course to begin. Note: Once you have taken all the refresher courses offered by CITI (up to Stage 4), you will be required to take the full course again.
Important note: The refresher course will only be available 90 days prior to your expiration date.
You will be asked to select and complete any 3 modules of your choosing. Doing so will renew your CITI human subjects protection training requirement for another 3 years. Note: GCP or SFVAMC refresher courses may have different requirements.
The SFVAMC requires regular training for all individuals engaged in research with human subjects, their tissue or data. If you are working at the SFVAMC, we recommend completion of the VA CITI training, which will meet UCSF’s requirements.
There are other education requirements for the SFVAMC, so ensure you and all members of your research team are current with those requirements. Contact the VA directly with questions.
Your previous CITI training may be valid at UCSF, depending on a number of factors. Follow these steps:
- Log on to the CITI site with your current login information.
- From the Courses Page click on the link "Add Institutional Affiliation"
- Type and choose the institution from search box. Add "University of California, San Francisco" (type out the whole name) as an affiliate organization and then enroll as described here.
- Confirm you have selected the right institution and agree to the Terms and Conditions.
- Answer the member information questions required by your newly affiliated institution and enroll in the course(s) [Human Subjects Protection Training] required by your newly affiliated institution.
- CITI will review the modules you previously completed and the date(s) on which you took them. CITI will ask you to complete any modules required by UCSF that were not required by your previous institution and/or modules that are no longer eligible to be transferred.
- To transfer course credit between institutions, you will need to be affiliated with both institutions (your previous institution and your new institution).
- When you are affiliated with both institutions, enroll in the courses that need to be transferred. You will need to enroll in the same stage of the course (Basic/ Refresher) for a proper transfer to occur.
Collaborators only need to complete this training if UCSF has agreed to act as their IRB of record. If outside collaborators have received their own IRB approval, they do not need to take the UCSF training and should defer to their own IRB's educational requirements.
If you forget your user name or password, click the "Forgot Username or Password" link on the CITI website. The UCSF IRB staff do not have access to your password/login information.
The CITI Support Center also provides resources and answers to frequently asked questions.