CITI Training Preparation Guide

CITI training is the near-universal human subjects research training in US academic institutions. Most IRBs will not review a protocol until every listed study team member has a current CITI certificate. This guide covers what CITI is, which modules you need, how long they take, how often you must refresh, and where students most often stumble.

CITI itself is a training platform — the "Collaborative Institutional Training Initiative" — operated by the University of Miami. Your institution subscribes and sets local completion requirements. Course availability and specific required modules vary by institution, so always check your office's guidance alongside this general overview.

What CITI is and why it exists

Federal regulations under 45 CFR 46.103 require institutions holding a Federalwide Assurance (FWA) to train investigators and IRB members on human subjects protections. CITI is the most widely used training vendor for meeting this obligation. NIH separately requires training for key personnel on any grant involving human subjects, and many private funders do the same. Completion generates a certificate with a completion date and (depending on course) an expiration date.

Which course do you need

Almost every institution offers at least two human subjects research (HSR) tracks through CITI.

Some researchers — for example, a public health investigator using both survey data and medical records — should complete both tracks or a combined course if the institution offers one. Your IRB can confirm.

Additional CITI courses you may need

• Good Clinical Practice (GCP) — required for NIH-funded clinical trials and FDA-regulated research
• Responsible Conduct of Research (RCR) — required by NIH and NSF for trainees on many grants
• Conflicts of Interest (COI) — institution-specific, often required annually
• HIPAA for Researchers — required when research accesses protected health information
• Subparts for special populations — modules for research involving prisoners, children, or pregnant participants. See the special populations guide for the underlying regulations.
• International Research — for studies conducted outside the US

Required modules inside each course

The specific modules required vary by institution, but a typical HSR course includes 10–14 modules drawn from the CITI library. Common required modules in the SBER track:

• History and Ethical Principles (Belmont Report)
• Defining Research with Human Subjects
• The Regulations and the Social and Behavioral Sciences
• Assessing Risk in Social and Behavioral Sciences
• Informed Consent
• Privacy and Confidentiality
• Research with Prisoners, Children, or Pregnant Participants (as applicable)
• Internet-Based Research
• Unanticipated Problems and Reporting Requirements

The Biomedical track adds or substitutes modules on FDA-regulated research, populations in clinical studies, conflicts of interest in biomedical investigation, and vulnerable populations in biomedical research.

Time investment

Plan for one to two workdays total if you are completing HSR plus one additional course. Most people do it over a week in 30–60-minute sittings.

Passing the quizzes

• Each module ends with a short multiple-choice quiz, usually 3–5 questions.
• Passing thresholds are institution-set, commonly 80%. The overall course score is an average.
• You can retake any module to improve your score before completing the course.
• Questions draw directly from module content — reading carefully is more efficient than guessing and re-taking.

Refresher requirements

CITI certificates typically expire. Common refresh intervals:

• HSR: most institutions require a refresher every 3 years (some every 2). Refresher courses are shorter, with updated modules.
• GCP: NIH policy requires retraining at least every 3 years for clinical trial personnel.
• RCR: varies; NSF requires training at least once per career stage.
• HIPAA: typically annually, though this is often handled through a separate institutional training rather than CITI.

Common stumbling points

• Enrolling in the wrong course. Some institutions list half a dozen CITI courses. Picking "Students — Research" instead of "Human Subjects Research — SBER" means you have to redo the work. Confirm with your IRB office before starting.
• Not linking your CITI account to your institution. If you created a CITI account under a personal email or a previous institution, your completion may not appear in your current IRB system. Add the new institutional affiliation in your CITI profile.
• Missing required supplemental modules. Research with children requires the Children subpart module; research with prisoners requires the Prisoners subpart module. Don't discover this mid-submission — plan ahead using the special populations guide.
• Letting the certificate lapse between submission and approval. Completion must be current at the time of IRB review. If your certificate expires during the review cycle, take the refresher before the board meeting.
• Confusing RCR with HSR. RCR covers broader research integrity; it does not substitute for HSR. NIH-funded trainees often need both.
• Forgetting co-investigators and students. Every person listed on the protocol must have current training. Research assistants who will interact with participants are included.

CITI preparation checklist

• Confirm which CITI courses your institution requires for your role
• Create or update your CITI account with current institutional affiliation
• Enroll in the correct HSR track (Biomedical or SBER) plus any supplemental courses
• Add subpart modules if your research involves special populations
• Complete modules in 30–60 minute sessions, aiming for 80%+ on quizzes
• Download your completion report (PDF) and attach it to your IRB submission
• Note the expiration date and set a calendar reminder 2–3 months before

Once your CITI training is in hand, you have cleared the single most common administrative blocker to IRB review. Move on to drafting the protocol itself, and pair it with a well-written consent form that matches.