Ascension Wisconsin is committed to providing researchers with appropriate training and ongoing education in the conduct of human subject research as a way to ensure safe, ethical and scientifically sound research.
In addition to required training, AWRI provides ongoing training support services and educational offerings.
Human Subject Protection Training
Each member of the research team interacting with human subjects must complete an educational module on the protection of human subjects.
If the same email address is used in Mentor and the CITI system, completion information is updated automatically. Alternatively, a copy of the completion certificate may be uploaded in your Mentor eIRB profile.
Instructions and References
- CITI Program Training Instruction Guide: account registration and completing required training
- IRB Guidance: Investigators and Research Personnel: determine who should be identified as a member of the research team
- Institutional Memo: CITI Training Requirement for Researchers
- Institutional Memo: Implementation of CITI Program Training
Any study team member that is working on an FDA regulated clinical trial will be required to take ICH-GCP training by the Sponsor, funding agency and/or the AWRI Clinical Research Department.
The CITI Program has an ICH-GCP optional module available to meet this requirement, although other training courses may also be acceptable. The CITI ICH-GCP course does meet the NIH and TransCelerate Biopharma requirements.
Other Training That May be Required
Depending on the kind of study or funding agency, you may need to complete other training. Some training my be required to satisfy regulatory requirements, and some may be required by the institution, IRB or Sponsor. Examples include:
fCOI: If you are working on any research that receives PHS funding, you will need to take the complete Financial Conflict of Interest (fCOI) course, in addition to the COI module included in the Human Research Protection course. This fCOI course meets PHS regulatory requirements.
RCR: Responsible Conduct of Research (RCR) must be completed for certain funding agencies, including National Institutes of Health (NIH), National Science Foundation (NSF), and U.S. Department of Agriculture (USDA). It is also recommended that all residents take this course, regardless of funding.
These as well as other optional courses, based on the type of research being conducted, are available in CITI.
FAQs for CITI Program Training
Who has to take CITI Training?
All investigators and key research personnel involved in the conduct of human subject research within an Ascension ministry must complete training in the protection of human subjects. This includes Investigators, research staff, IRB members, the Signatory Institutional Official, and Administrative Research staff.
What if I already took CITI somewhere else?
If you have completed CITI training at another institution, you can “affiliate” with Ascension Health. By doing this, your completed courses are combined so that you need not retake modules common to the requirements of both institutions.
See the CITI Training Guide document for instructions on how to affiliate your account.
How long will it take me to complete CITI training and do I need to complete it all at once?
The amount of time needed to complete CITI will depend on your role in research. The average learner spends approximately 4.5 hours to complete the Basic Course and 2 hours to complete a refresher course. The courses do not need to be completed in a single session, so you can log in multiple times to complete the course.
How often do I have to take CITI?
Once passed, courses are valid for three years, after which time training must be renewed by completing a refresher course. Ninety days (90) prior to course expiration, you will receive an e-mail regarding your required CITI refresher courses.
How do I register for CITI training?
The program is web-based and accessible online from any computer or device. See the CITI Training Guide document for step- by-step instructions on how to set up your account.
How do I know what courses do I need to take?
In CITI, you will select courses based on your role in research and the kind of research you do. The basic Human Research Protection courses are based on your role (i.e. Investigator, coordinator IRB member, etc.).
In addition, CITI training is also available to meet other regulatory or institutional requirements, including Financial Conflict of Interest, Good Clinical Practice (GCP), Responsible Conduct of Research (RCR), Biosafety and training form IRB members and Research Administration staff. You will select these optional courses if you are involved in certain types of research.
There are descriptions in CITI to help you to make the best selections. There are also more details in the CITI Training Guide document.
What if I forget my login information?
If you forget your user name or password, follow the "Forgot login information" instructions on the CITI website. The RI&P staff does not have access to your password.
How do I obtain a certificate of completion?
After you finish the required modules, you will be issued a completion report that is available to print or save from your learner menu. For help saving/printing the report, visit the CITI website. RI&P staff will not be able to print your certificate for you.
You should save or print the report for:
- Your records
- Give a copy to any members of your administrative team who need it for the study records
- Your CITI completion will automatically be sent to the IRB in Mentor. The IRB receives a nightly updates from CITI, so it may take up to 24 hours for CITI completion to be reflected in Mentor.
Be sure to use the same email for your CITI account that you use for your Mentor eIRB account. The email address links the two systems. If they don’t match, the IRB will not see that CITI is complete and you will need to provide the completion certificate to them.
Can I get Continuing Education (CE) credits for competing CITI?
CITI offers CE credits and units for purchase to learners qualifying for CE eligibility while concurrently meeting their institutions training requirements. CE credits/units for physicians, psychologists, nurses, social workers and other professions allowed to use AMA PRA Category 1 credits for re-certification are available for most CITI courses. For more information about CE credits, and qualifying for and purchasing CE credits, see the CITI site.
Ongoing Training Support
IRB Training and Office Hours
Mentor eIRB Training
There are no scheduled Mentor eIRB training events at this time. However, training and assistance with Mentor is offered to individuals on an ongoing basis. To schedule a training time, please contact the IRB staff by email or at 414-465-3059.
IRB Office Hours
You can contact IRB staff with questions at any time, however, staff have designated office hours where they are immediately available to take calls and emails on a first come, first served basis.
Tools and Templates
Research Quality Management develops tools and templates for study teams to use during the conduct of the study, such as regulatory logs, files and study checklists. All tools are available on the Research Quality Management page.
Education and Events
Personalized Education SessionsResearch Education and Quality Management provides various personalized education and training on request including study stat-up consultations and study team training on special topics, like obtaining consent. You can find more information and request services on the Research Quality Management page.
REQM facilitates education events like presentations or round table discussions on various topics including, IRB submission, research ethics, research compliance and good clinical practices.