The CITI Training Program
The Carilion Clinic Institutional Review Board (IRB) requires that anyone conducting research studies that involve human subjects must complete training on the responsible, ethical conduct of research. This training includes the history of research studies in the United States and addresses your responsibilities as a researcher for protecting the rights of research participants. The two most common certificates for training are the Collaborative Institutional Training Initiative (CITI) and the National Institutes of Health (NIH). Researchers at Carilion Clinic and Jefferson College of Health Sciences are required to complete the CITI Training program, whereas a researcher who receives a NIH grant must complete the NIH training.
If you are thinking about initiating a research study at Jefferson College of Health Sciences or Carilion Clinic, or are considering participating as a member of an already active research team at Jefferson College, Carilion Clinic, or Virginia Tech, you are required to complete CITI Training before your study can be initiated/before you may be added to an active research team. The CITI Training program is free. The training will take between 3-5 hours and can be completed over several days if needed. Follow the instructions below to determine which curriculum you should take. Each CITI curriculum consists of a series of required modules and each module has a short quiz. You must pass each quiz with a minimum score of 80%. A running tally is compiled in the Grade Book. If you want to improve a score, you may repeat any quiz in which you did not score 100% correct by selecting the tab 'view this module again.'
CITI for Investigators and Study Staff
For investigators and staff involved in FDA-regulated/drug/device research:
- Good Clinical Practice (GCP)
FDA-regulated research requires completion of the Good Clinical Practice module. This training must be repeated every three years for investigators and staff who continue to participate in new FDA-regulated studies.
For investigators and staff involved in non-FDA regulated biomedical research:
- BASIC Biomedical
- Refresher 101 Biomedical
- Refresher 201 Biomedical
For investigators and staff involved in social/behavioral research:
- BASIC Social/Behavioral
- Refresher 101 Social/Behavioral
- Refresher 201 Social/Behavioral
Researchers and staff conducting research must first complete the Basic education module. After three years, investigators and staff must take the Refresher 101 module in order to participate in new studies. After six years, investigators and staff must take the Refresher 201 module in order to participate in new studies.
Investigators, study coordinators and other research staff are required to complete the appropriate CITI training before their research can be approved by the IRB. This requirement applies to all human subjects research.
The Conflict of Interest Mini-Course must be completed by researchers and staff who conduct research with external funding or support. The mini-course must be taken once every four years. Courses for IRB Members should not be taken by research personnel.
Upon completion of a required module, print or download a Course Completion Report as evidence that you have met the IRB training and education requirement. A report will automatically be sent to the IRB office from CITI. Call the IRB Administrator at 853-0728 if there are any questions.
Accessing the CITI Training Program
- Go to www.citiprogram.org
- In the top right hand corner of the page, select "Register" to create a new user account.
- Step 1: Select Your Organizational Affiliation. Type "Carilion Clinic" into the search box.
- Continue to Step 2
- Step 2: Enter Personal Information
- Continue to Step 3
- Step 3: Create Username and Password
- Continue to Step 4
- Step 4: Enter information for Gender, Ethnicity, and Race (or select "prefer not to answer")
- Continue to Step 5
- Step 5: Are you interested in receiving CEUs for completing the CITI Program Course? Select "No" unless there's a compelling reason for requesting CEUs.
- Continue to Step 6
- Step 6: Enter requested information. You do not need to enter an employee number. For Department, enter your home department
- Continue to Step 7
- Step 7: Select the training curriculum or refresher courses most appropriate to your research study and begin the curriculum.
Upon Completion of CITI Training
Upon completion of required course, print or download a Course Completion Report as evidence that you have met your educational requirement. A copy will automatically be sent to the IRB Office. Call the IRB Administrator at (540) 853-0728 if there are any questions.
Please Note: Effective 1/1/17, all IRB submissions must include completed Humans Subjects Protections training through https://www.citiprogram.org/ for ALL team members listed on the IRB application. If a team member has not completed the appropriate CITI training at the time of submission, the IRB application will be returned to you as incomplete and will NOT be processed by the IRB. You will then have the option to remove the team member and resubmit, or resubmit once all team members have taken the training.
This new policy is being implemented to encourage the completion of training before the writing of the IRB application so that all researchers have a basic understanding of ethical conduct of research and research regulations when designing and writing the study. In addition, this will reduce IRB turnaround times as the IRB will not need to hold an application approval until CITI training is completed, and those studies whose team members have completed training will receive priority for IRB review. Thank you for your cooperation and understanding.
CITI Technical Questions?
For technical questions regarding the CITI webpage, please contact the CITI support desk at 888-529-5929 or firstname.lastname@example.org or follow the links below for assistance.