Required CITI Training
CITI is a well-respected and widely used web-based training program that was designed by and is updated and maintained by a number of nationally known IRB professionals.
The CITI Program is designed around topic specific modules, each followed by a short quiz. Completion of the requirements takes between 3.5-4.5 hours for most participants. CITI allows you to log-off at anytime and it will keep a record of your progress through the training. You do not have to complete the training in a single session.
Once you visit the main page, select Register for the CITI course, then select New York State Psychiatric Institute under "Participating Institutions."
Required CITI Training
The Research Foundation for Mental Hygiene, Inc. and the NYS Office of Mental Health have issued a policy regarding training in human subject protection for all researchers, key personnel, IRB members, IRB staff, and Institutional Officers involved in human subjects research or its oversight.
All those who play a significant role in the design, conduct, or oversight of research that is reviewed by the NYS Psychiatric Institute IRB are required to complete a web-based instruction course known as "CITI" (Collaborative IRB Training Initiative) prior to taking part in research. A "refresher course" is required every three years. Researchers are also encouraged to avail themselves of the many lectures, seminars, workshops and courses in ethics and human subjects protections offered at NYSPI and Columbia University Medical Center. Finally, we encourage new investigators to join us at a Wednesday subcommittee to get a first-hand look at the review process. Contact the IRB office for more information.
If you have already completed CITI training with Columbia, or with some other institution, please note that THE TRAINING IS NOT RECIPROCAL. You must complete all of the modules that are required by NYSPI. See CITI FAQs for instructions on how to affiliate with another institution, in this case, New York State Psychiatric Institute, and complete whatever additional modules are required.
Documentation of completion
Each principal investigator will be required to attest in the IRB Protocol Summary Form to the fact that all study personnel required to complete the CITI course have done so. PI's or department heads are expected to maintain documentation of staff certification.
- What is CITI?
The Collaborative Institutional Training Initiative (CITI) program was founded in March 2000 as collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a training program to promote the responsible conduct of research. It is a well respected and widely used Web-based program designed around topic-specific modules, each followed by a short quiz. The content is extensively reviewed, updated and maintained by a number of nationally known IRB professionals
- Who must take the CITI Training Program?
All researchers and key personnel who play a significant role in the design or implementation of the study, those who otherwise interact with human subjects, and those who work with identifiable human subject data who submit research for review by the New York State Psychiatric Institute IRB .
IRB members, IRB administrative staff, and other institutional officials involved in research oversight.
For studies reviewed by the NYSPI IRB where research is being conducted at another site under the jurisdiction of a local IRB, local site investigators must confirm human subject protection training in accordance with their local IRB's requirements. NYSPI and CU personnel must complete the NYSPI CITI requirements.
Similarly, collaborators from other institutions will not be subject to the NYSPI requirement, but must confirm human subject training in accordance with their home institution's requirements.
- What ongoing training will I need once I complete the CITI program?
Individuals are encouraged to supplement the CITI training with participation in local and external programs. For Columbia University faculty and staff, additional requirements to complete the Columbia University Medical Center GCP and HIPAA Training and Clinical Research Coordinator ("CRC") training also may be required.
All Principal Investigators acting as a "Sponsor-Investigator" (S-I) for research involving an IND or IDE are required to fulfill the mandatory CUMC training for FDA regulated Human Subjects Research. Questions regarding the requirements should be directed to the Clinical Trials Office (CTO) at CTOinformation@columbia.edu. The IRB will not approve the enrollment of subjects in S-I research until the CTO notifies the IRB that the mandated prerequisites of the IND/IDE Assistance Program have been met.
In addition to the required Basic and Refresher training, the CITI web site also offers a course in Good Clinical Practice. The Course has a comprehensive variety of learning modules that are particularly beneficial for investigators and key personnel involved in clinical research, clinical trials or research involving investigational drugs, devices, or biologics.
- When do I have to complete Refresher Training?
The CITI training program sends an automatic e-mail notification to those who completed the original Basic Course for New York State Psychiatric Institute. The e-mail is sent 90 days in advance of the individual's expiration date, and will include instructions on how to access the Refresher Course.
If you completed CITI training for a different institution, you will not receive an email notice for New York State Psychiatric Institute. You will therefore need to log on to the CITI program and update your institutional affiliation to fulfill requirements for New York State Psychiatric Institute by completing the Basic Course or the Refresher Course. For those key personnel, staff, IRB members and institution officials who are new, the Basic Course must be completed.
- What happens if I don't complete the training?
All persons involved in research involving human subjects must complete the CITI training prior to participating in the design or conduct of the research. Failure to do so can delay approval of an IRB submission. Additionally, PRISM is linked to CITI. So if you have not completed the training or you are out-of-compliance with refresher course requirements, your name will not appear on the PRISM drop down list.
- How does CITI work?
Each time you login to the CITI site, CITI's grade book will keep track of the modules and quizzes you have completed. The study modules may be completed in multiple sessions. CITI will also keep track of where within a module you are each time you log out. The required modules must be done in the listed order, but the optional modules can be completed in any order.
After completing all the modules (required and elective) for your learner group, CITI will provide you with a certificate of completion if your score is 90% or better. You may return to the quiz if a response is incorrect and re-take the quiz. The course provides correct answers and explanations.
The NYSPI IRB Office will be notified when you complete the training.
- What happens if I forget my CITI username or password?
Click on the box stating FORGOT LOGIN INFORMATION on the CITI "Welcome" Page. The system will send your user name and password to your e-mail address.
- How do I access CITI?
To access CITI, go to https://www.citiprogram.org/default.asp. Select NEW USERS and register or Select ALREADY REGISTERED.
- How do I access CITI at home?
You can go to the web site https://www.citiprogram.org/default.asp at home and click on "Register for the CITI course" and follow the instructions. You can access the CITI site from any internet connection.
- I already completed CITI training for another institution. How do I transfer my completion certificate to New York State Psychiatric Institute?
You can log onto the CITI site with your other affiliation. Once you log on, you will be directed to the Learner's menu. Here you can choose to add New York State Psychiatric Institute from the drop down menu as another affiliation. You will likely be required to complete additional modules to fulfill the NYSPI training requirements.
- What if I have completed the CITI Training for Columbia?
The training is not reciprocal. Although some of the modules are the same, the requirements are not the same. The modules you have completed may count toward the NYSPI requirement. If you are already registered in CITI, you do not need to create a new registration. You can login and click on "Affiliate With Another Institution" and choose New York State Psychiatric Institute from the drop down menu.
- How do I know which Learner Group to select?
Select the "learner group" which is most applicable to you: Depending on your role in research, when you register, you will be asked a series of questions to be assigned to one of 4 learner groups: Biomedical Researchers and their Key Personnel, Social and Behavioral Researchers and their Key Personnel, IRB Staff/IRB members, Institutional Officials & Their Designee. You also can add a course or change your learner group.
Individuals who are both biomedical and social and behavioral researcher should select Biomedical Researcher.
Biomedical or Social and Behavioral Researchers who are also IRB members should select a Researcher group, but you are also be required to select the IRB member training module from the optional module list within the course.
Institutional Officials or Designees who are also researchers should select a Researcher learner group
- How do I know which modules to complete?
The Grade Book on the Learner's menu includes instructions for required modules and elective (optional modules). The required modules must be done in the listed order but the elective modules can be completed in any order. You must complete all of the required modules, and a set number of elective modules, depending on your Learner group.
- What is the CITI "Integrity Assurance Statement'?
This is a CITI requirement that all learners must read and complete indicating that they are taking the course for themselves. Learners cannot access any modules until the Integrity Assurance Statement has been completed.
- How do I document that I have completed the CITI Training Program?
When you have completed the training requirements, CITI allows you to print out a certificate of completion. Please retain a copy for your records. You do not have to submit a copy to the IRB. The NYSPI IRB will be notified by email so you do not have to provide the certificate to the IRB Office.
With each new IRB submission and at the time of continuing review, each principal investigator is asked to attest to the fact that all study personnel required to complete the course have done so. PI's or department heads are expected to maintain documentation of staff certification. The IRB will conduct periodic audits of these study records.
- Is the Good Clinical Practice Course required?
This is a required training for researchers and their staff. Some of the modules are already included as requirements for the Refresher Training for Biomedical Researchers and key personnel. Your completed course work will count toward completion of the CITI GCP Course. You can choose to take the CITI Good Clinical Practice Course at any time, even after completing the Basic Course or Refresher Course.
- Who do I contact with questions?
If you have any additional questions about CITI requirements write to firstname.lastname@example.org. Technical questions regarding the CITI website should be directed to CITI's technical support: 888-529-5929 or email@example.com.