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CITI (Collaborative Institutional Training Initiative)

CITI is a compendium of resources used by many academic research institutions to meet their personnel training needs. Each client can select from and tailor web-based course offerings to ensure that all personnel meet their institution’s training requirements in a standardized manner.

Individuals who are engaged in the planning, conduct or analysis of human subject research as affiliates of the University of North Carolina at Chapel Hill (UNC-CH) are instructed to complete one or more CITI trainings based on the role they play and/or the type of research being conducted.

Generally, individuals are considered engaged if they will have direct contact with participants/potential participants and/or if they will have access to any of the 18 HIPAA (Health Insurance Portability and Accountability Act of 1996) identifiers that may be accessed, recorded and/or stored in conjunction with research subject recruitment, screening/enrollment, or interaction.

Disregard for mandatory training has several implications: it may prevent approval of an IRB application; it may jeopardize the relationship with a funder or Sponsor; or it may delay the release of a project account/funding from the UNC-CH OSR (Office of Sponsored Research).

What CITI Courses/Modules are Required at UNC-CH?

  1. Human Subject Protection (HSP) training (sometimes referred to as “IRB” or “ethics” training). HSP training focuses on historical and current norms regarding the ethical and scientific principles governing how research involving human subjects should be designed, performed, and reported in such manner as to offer equitable participation, fully describe potential risk and benefit, and protect subjects’ privacy and confidentiality. There are three modules for HSP, grouped by category/type of research; personnel should complete one, based on the type of research with which they are most often involved:

    Group 1 – Biomedical Research: Medical, physiological or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices or other interventions.

    Group 2 – Social and Behavioral Research: Studies on sociological, psychological, anthropological or educational phenomena that typically involve direct contact with subjects. Excludes drug or device studies.

    Group 3 – Data and Specimens Only: No direct contact with human subjects; Research limited to use of records, data (including secondary datasets), or biological samples.

    Note: In addition to Group 1, 2 or 3 above, personnel may be instructed (or wish) to complete HSR Optional Modules.

    Expiration: Currently, HSP training certification does not expire. If this changes in the future, the validation period will be posted on the UNC OHRE (Office of Human Research Ethics) Office.

  2. Good Clinical Practice (GCP) training. In addition to HSP training, GCP training is required for personnel who are involved in human subject clinical trial research involving a drug, device or biologic or whose study is NIH-funded or -sponsored. GCP builds on HSP training with a focus on conduct, such as study design, provisions for data acquisition and storage, procedures for biospecimen collection and sharing, and data and safety monitoring, insuring that the burden of participation is commensurate with the importance of the knowledge to be gained and that researchers are appropriately trained to perform study procedures . There are two modules from which to choose, based on the type of research with which the individual is most commonly involved:

    GCP for Clinical Trials with Investigational Drugs, Biologics and Devices: “Clinical trial” is defined by the NIH as, “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

    Social and Behavioral Research Best Practices for Clinical Research: Clinical research that does not involve a drug, device, or biologic.

    Note: In addition to the two GCP modules above, personnel may be instructed (or wish) to complete GCP Elective Modules.

    Expiration: GCP training certification is valid for 3 years; thereafter, a GCP Refresher Course is available for trainees who act timely to recertify.

How to Access CITI Training

  • If you are currently affiliated with UNC-CH, select “LOG IN” and enter your Onyen/Password.

  • If you are listed as research personnel on a UNC IRB, but do not have an active Onyen/Password:

    • Create a Username/Password and log into CITI using “LOG IN THROUGH MY INSTITUTION”
    • Select UNC-CH as your Participating Institution

    Note: For the link to CITI to work, you must enter your email address into CITI exactly as it appears in the IRB application.

  • If you completed CITI training at another institution – AND if the completed modules match the modules required by UNC-CH, they may be transferred electronically:

    • Log into CITI using your former institution Username/Password
    • Click “Affiliate with Another Institution”

    • Select UNC-CH as your Participating Institution

      • If you have a UNC PID:

        Enter your member information and PID (9 digits, no spaces); and
        Do not remove your former institutional affiliation.

      • If you do not have a UNC PID but you are a UNC Healthcare employee:

        Enter your member information and hospital ID in the UNC-CH PID field (the same ID you use to access Epic); and
        Do not remove your former institutional affiliation.

      • If you do not have a UNC PID or UNC Healthcare ID:

        Enter your member information and four zeros (0000) in the UNC-CH PID field; and
        Do not remove your former institutional affiliation.

For more information regarding CITI training, call OHRE at 919-966-3113 or irb_training@unc.edu.