CITI Education for Biomedical Investigators and Staff

Who is required to take CITI training?

Completion of Collaborative Institutional Training Initiative (CITI) training should be done by all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for designing and/or conducting research, performing data analysis or reporting activities) or serving on a Sutter Health (SH) research committee. The Sutter Health Institutional Review Board (SHIRB) requires all Investigators and Key Personnel named to the study team to have current CITI coursework certifications in order to obtain research study approval.

Definitions

• Sutter Health Investigator — means any SH employee, contractor, or affiliated medical group member or independent provider who serves or plans to serve as the role of principal investigator or sub-investigator on a Research project that includes one or more SH Resources (e.g. laboratory testing, clinical imaging, RI staff).
• Senior/Key Personnel — means any person identified as such in the grant application, progress report, or any other report submitted to federal grantors or, in the case of non-federal projects, as identified by those authorized by Sutter Health to determine Senior/Key Personnel. Senior/Key Personnel are understood to be personnel whose replacement would constitute a threat to the continuation of the research.

Applicable Policies

• Research Financial Conflict Of Interest — specifying COI training every four years
• Research Management and Oversight — specifying that all SH investigators shall conduct their research under RI management and oversight.

CITI training certification is required to be current at the time of annual IRB renewal. In the event that any Investigators or Key Personnel are not current in CITI certification requirements, the Sutter Health IRB shall restrict new enrollment and data collection until all training is complete.

Getting Started and Registration

New Users

• Go to the CITI website to create a CITI account.
• Click “Register” to create your account
• Select Sutter Research Enterprise as your organization affiliation, click to agree with Terms of Service continue to step 2
• Complete steps 2, 3, and 4 by entering your personal information, Create your username, password and security question, Complete country of residence, continue to step 5
• Complete CEU credit options, continue to step 6
  • WARNING: If you select to receive CEU credits, you will need to pay upon completion of the course modules in order to receive certification and CEU.
• Enter your Sutter Health email address and select CPMCRI  as your Research Institute affiliate from dropdown, continue to step 7
• Select your courses:
  • Select Human Subjects and then select that it is your first time taking CITI
  • Select your role (Biomedical Investigator or Sub-Investigator, IRB member, etc.)
  • Select the following courses (bold is required for everyone):
    • Biomedical Basic (this is Human Subjects Protections [HSP])
    • Good Clinical Practice Basic
    • Conflicts of Interest Basic
    • Phase 1 Research – ONLY if you conduct Phase I clinical trials
    • Humanitarian Use Devices (HUD)/Humanitarian Device Exemption (HDE) – ONLY if you work with an HDE/HUD
    • Human Gene Transfer – ONLY if you conduct Human Gene Transfer research
    • Recombinant and Synthetic Nucleic Acid Molecules –ONLY if you conduct research with recombinant and/or synthetic nucleic acid molecules

To complete the training you must pass all required modules for your Learner Group by gaining at least an 80% average on the module quizzes. Please save your certificates.

Transferring Training from Another Institution

Transfer CITI training completed at another institution:

• Login to CITI website directly with your CITI or prior institution's login credentials.
• Click on the link Affiliate with Another Institution and choose Sutter Research Enterprise.
• Enroll in the course(s) required by Sutter Health (see above list of courses)
• Your previously completed modules will be reflected in Sutter Health’s CITI account.
• Complete any outstanding modules that are required at Sutter Health. These will be listed with a status of “Not Started” or “Incomplete”. There may be courses that were not required at your previous institution.
  • If issues in transferring: Report the issues to CITI support center.

Obtaining a Copy of the Completion Certificate

You can view and print a copy of your completion certificate by logging into the CITI home page.  At the "Learner's Main Menu":

• Click “View-Print-Share”
• Click hyperlinks under “Completion Reports” or “Completion Certificates” to view, print or share your completion report or certificate

If under the Status heading it says "Passed", then click on the PRINT link under Completion Reports.  This will display a table. Click “Print Completion Report” to print the certificate. 

If under the Status heading it says "Not Started - Enter" or "Incomplete - Re-enter", click on Previous Coursework Completed link, then click on See Coursework Completed.  When the table is displayed, click on the “Print Completion Report” link.

Refresher Courses

How often do I have to take this course to keep my training current?

• Training is required every three years. You will need to access the CITI tutorial again to take the Refresher course, so make sure you record your username and password for future use. After the first training, CITI will send a notification to your registered email 90, 60 and 30 days prior to expiration for Refresher Course completion.

What if I take my Refresher course 'early'?

• When you take the Refresher course, your expiration date is three years from date of completion.
  
  Example:  Your current expiration date is in June; CITI sends you an automated reminder three months before, in March.
  
  If you take your Refresher course immediately (in March) your next expiration date will be three years from March (not from June).

General Information and FAQ about Taking the Coursework

Selecting a Learner Group

There are several Learner Groups to choose from, with each group reflecting a different research area of focus. Group descriptions are provided when you register for CITI. Choose a Learner Group that best reflects your area of research and responsibilities.

• Human Subjects — For Medical Research Investigators and Staff, conducting research at all Sutter Health Affiliates and Clinics are required to take the following Biomedical Research: Biomedical Basic (Human Subjects Protections/HSP) , Good Clinical Practice Basic (GCP), and Conflicts of Interest Basic (COI)
  • Additional courses are provided and may be selected depending on your role including IRB members; Social Behavioral or Educational research; Specimen shipment; Data collection
• Animal Care and Use (ACU) — For staff conducting animal research at CPMC and SIMR
• Bench Science — For staff conducting Bench Science at CPMC

Can I complete this training in several sessions?

• Yes, you can leave and come back to the site using your CITI username and password as often as necessary. All completed work is stored. Save your work before you exit, and remember your user name and password.

How long does the Human Subjects Protection Training course take?

• Most users complete all of their required modules in 2-4 hours.

What if I have forgotten my username or password?

• From the CITI website login page, click the forgot? link in the username or password field. You will be prompted to reset your password or retrieve your username.

What if I have more than one CITI Username?

• If you have more than one CITI Username associated with your email addresses, you have more than one account. To merge your accounts, visit the CITI Support Center.