NIH CITI Training
Investigators who are covered under the NIH Federalwide Assurance (FWA) and conduct human subjects research (HSR) must complete NIH-required HSR training through the NIH CITI Portal. This page explains who must complete training, how to access the portal, and how training records are used in PROTECT.
Investigators who are covered under the NIH Federalwide Assurance (FWA) and conduct human subjects research (HSR) must complete NIH-required HSR training through the NIH CITI Portal. This page explains who must complete training, how to access the portal, and how training records are used in PROTECT.
Who must complete NIH CITI training?
If you are covered by the NIH FWA and are doing human subjects research, you must complete NIH-required training through the NIH CITI Portal. OHSRP staff, IRB members, and ORSC staff supporting clinical research must also follow the NIH policy on training.
- NIH Employee (intramural or extramural)
- Special Volunteer*(Only individuals classified as Special Volunteers in the NIH Enterprise Directory (NED) are automatically covered under the NIH FWA.)
- Intergovernmental Personnel Act (IPA) appointee (distinct from IPA detailee)
- Visiting Fellow (VFs)
- Intramural Research Training Awardee (IRTA)
- Cancer Research Training Awardee (CRTA)
- NIH Contractors when:
- working at an NIH site with an NIH employee, or
- the OHSRP Director (or designee) determines that the NIH FWA covers the contractor's activities.
* Other volunteer classifications are not covered by the NIH FWA and may require a written agreement before participating in human subjects research.
If you are not automatically covered by the NIH FWA, you should follow your home institution's training requirements unless you are working under an Individual Investigator Agreement or FWA Coverage Agreement. If working under those agreements, you should complete NIH training requirements or, in the absence of that, training acceptable to the NIH IRB per Policy 103.
How do I access CITI training?
Sign in using your PIV card or use the Authenticator App. Additional information about how to access the NIH CITI portal and how to find courses is provided below.
- Clear your browser's cache
- Close the browser (make sure you closed all the browsers' windows that might be on different screens, collapsed, etc.)
- Open a browser in Incognito (for Chrome) or InPrivate (for Edge) mode (to ensure that any old sessions stored in the browser do not interfere with the current session)
- Go back to this CITI training page
- Click on "Access the NIH CITI Training" link above
- Once on NIH Login page, click on "Sign in" button
- Choose correct certificate (you may have multiple certificates presented to you, you need to choose the correct one)
- Provide PIN number
- Click on "I Agree" button
If you still are receiving an error message after clearing the browser's cache, please enter a help desk ticket.
Unaffiliated IRB Members: Unaffiliated IRB members should login in via the main CITI site (not via the NIH portal on our website) using the username and password established when they joined the NIH IRB. If you need assistance accessing the account or cannot remember the username or password, contact Peg Sanders.
What is the required training for NIH investigators conducting HSR and others involved in NIH HSR?
Important Points to Remember about HSR training at NIH
- All NIH investigators must have up to date HSR training.
- The CITI basic courses and the CITI GCP course expire three years after the completion date. All staff then need to take the relevant CITI refresher course.
- Complete required refresher training before current training expires.
- CITI will make the refresher courses available 90 days before the existing course expires but not prior to that date.
- Do not attempt to take the refresher before you receive the reminder notice from CITI that your course is expiring. CITI will send email reminders of the pending expiration, and you can sign in via the NIH CITI portal to complete the refresher course(s) after receiving that email and before the expiration date.
- The NIH IRB will not process a submission if required training has expired for a study investigator. It will return the submission to the PI to let them know an investigator on the protocol does not have current HSR training.
- NIH may require additional education based on your research role, the research you conduct or as part of any corrective action plan.
- NIH Staff with access to the CITI Portal can take additional educational courses even if they are not required by policy. If you have an account in the NIH Enterprise Directory (NED) or are an unaffiliated NIH IRB member, you can access various CITI training modules through the NIH CITI portal. Just click "Add a Course" at the bottom of your course list in your CITI account.
How can I check for completed NIH Staff CITI training records?
Access the CITIHub
Developed by the NCI Center for Cancer Research (CCR), CITIHub allows NIH staff to view completed CITI training records and download training certificates for regulatory and study files. This resource is available only from within the NIH network.
Investigator Responsibilities
- Confirm whether the investigator is covered under the NIH FWA.
- Complete NIH-required CITI training or the training required by the investigator's agreement or home institution.
- Transfer prior CITI records if the training meets NIH requirements.
- Make sure training records are available in PROTECT before study activities begin.
Frequently Asked Questions
If you completed CITI training at another institution and the training meets NIH requirements, you may be able to transfer your records to the NIH CITI Portal.
If you do not already have an NIH CITI account:
- Create an account through the NIH CITI Portal
- Follow the instructions for transferring your existing CITI training records.
Detailed instructions are in the FAQ below.
Your NIH CITI account must use the email listed in the NIH Enterprise Directory (NED) for your training records to download into PROTECT. Enter your name and click the “Find” button.
When the page with your information opens, scroll down to the line that says NIH Email. Be sure to use this as your preferred email address in your NIH CITI account profile, since this is the email address required to download training records from CITI to PROTECT.
When you open the NIH CITI Portal, do NOT click on Add Institutional Affiliation. Instead, click on “View Courses” to the right of National Institutes of Health.
You may see courses listed under Active Courses or Courses Ready to Begin.
If the course you need to complete (e.g. Biomedical 101, Good Clinical Practice Course (US FDA focus) etc.) is not listed, scroll to the bottom of the page and click on “Add a Course.”
This will take you to a list of all CITI courses available via the NIH CITI portal. Click the box in front of the course you want to take and hit “Next” at the bottom of that page. The course you selected will then appear in the “Courses Ready to Begin” section. Once you have completed a course, the completion information should be available in PROTECT the next day.
After accessing the NIH CITI portal as described above, click on “My Records” along the banner at the top of the page.
A list of the courses you have completed will be displayed along with completion and expiration dates.
Log into PROTECT. In the upper right corner, click on the down arrow (caret) next to your name, and then click on “My Profile.”
Once the profile opens, scroll down to the section labelled “Training Courses” where your CITI course completion records will be listed.
If there are any training discrepancies (e.g. you believe you have completed the NIH required CITI training, but it is not in PROTECT), please submit a PROTECT Help Desk Ticket and attach the completed training certificates. This will allow the NIH PROTECT Support Team to troubleshoot the reason for failure of the training records to download into PROTECT.
Training records completed through the NIH CITI Portal automatically download into PROTECT, typically by the next day. IRB staff use these records to verify that investigators have completed the required training before processing protocol submissions.
Key Takeaway
If an investigator is covered under the NIH FWA, complete NIH-required training through the NIH CITI Portal. If the investigator is not covered under the NIH FWA, follow the training requirements that apply under the investigator's agreement or home institution.
Need Help?
Contact OHSRP for help with NIH CITI access, record transfers, or determining which training applies.