Research and Sponsored Programs

IRB Manager: Software for human subjects research protocols

What is IRB Manager?

IRB Manager is the product selected to replace Kuali Coeus (KC).  It will be used for the entire lifecycle of human subjects research, from the development and submission of protocol applications by researchers to the review of the applications by the Institutional Review Board through approval, amendment, renewal, and eventual closure.

IRB Manager, despite its name, allows for the full suite of compliance processes to be handled in one system.  After the rollout for IRB is complete, implementation for the IACUC and IBC processes will begin.

NEWS BULLETIN

Conversion of data from KC and RSP into IRB Manager is complete!

As of Tuesday December 10, 2019, your RSP study is in the IRB Manager system. Since your study did not originate in IRB Manager, you must "backfill" the initial application form before submitting an amendment request. 

  1. To backfill the application, you should email the appropriate IRB email box (irb.biomed@utoledo.edu or irb.sbe@utoledo.edu) with (1) the study number, (2) PI name and (3) which member of the research will be conducting the backfill.  Anyone listed on the study can request the backfill. 
  2. The HRPP will process the request to allow for backfill and will email the PI and research team member who will be conducting the backfill (if not the PI). Instructions will be provided.
  3. You will open the study and scroll down to “Study-Site Attachments.”  Find the “KC Questionnaire” attachment and open the document.
  4. Copy and paste responses from the KC questionnaire into the New IRB Research form.  The form has been modified so not all questions will be identical and there may be additional questions to answer.
  5. Once completed, submit the form.
  6. The HRPP will verify your responses and either request edits or indicate that the backfill is complete.
  7. Once the backfill is complete you can begin an amendment.
IRB MANAGER
  1. Quick Reference Guide to the Dashboard Screen (2 pages)
  2. Instructions for uploading/updating your HIPAA Training in IRB Manager
  3. Instructions for PIS and Dept Chairs Requested to sign an IRB application
  4. Instructions for Creating and Submitting Amendments
VIDEO TUTORIALS
  1. From Login to Dashboard (0m 28s)
  2. Dashboard Terms: Studies, XForms, Events (3m 54s)
  3. Adding Personnel to a Study and to IRB Manager (1m 52s)
  4. CITI Training Records and HIPAA Certifications (5m 10s)  RELATED: Establishing a CITI Account (PDF)
  5. Uploading HIPAA Training Certifications (1m 45s)
  6. Finding Your Stamped Documents and Approval Letters (2m 39s)
  7. Starting a Simple Personnel Amendment (2m 12s)
irb manager - frequently asked questions
 Q. When will IRB Manager replace Kuali Coeus, aka KC?

 A. All new protocol applications for IRB protocols started going through the new system on October 29, 2018!  Amendments and other post-approval actions on these applications will be available shortly thereafter.
 Q. Will it be easier to use than KC?

 A. Yes!  We have had many users try the system, and the unanimous view is that it is significantly easier and more intuitive than KC.  Most people are able to navigate the application quite easily. Help with navigating the system overall will be provided by Human Research Protection staff, and through short online videos (in development as of Oct. 30, 2018).
 Q. I have protocols in progress or underway already in KC.  What happens with those?

 A. The studies in KC will be imported into IRB Manager in the coming months.  An announcement of the progress of the transition is available now at the bottom of this page.  When the transition is complete, and amendments and continuing reviews for legacy data will be put through the new system.  If you have concerns about a particular protocol, amendment or renewal, contact your IRB Administrator.

 Q. Will there be training sessions? Can we get help when we need it?

 A. Training sessions were held on each campus Oct. 22 and Oct. 24. We do not have additional sessions scheduled (we don't believe they are needed), but the IRB staff are willing and able to help too, and many questions will be answered with online tutorial videos after Oct. 29. If you're having problems, we'll help!  If the demand is there for more sessions, we will schedule them.  Contact Rick Francis to express interest.

Q. How do I log in to the system? 

A. Click the blue button above, or just head to irb.utoledo.edu in any browser.  You will be able to log in with your UTAD credentials.  If you are a community member who logs in with your own non-UTAD credentials, be sure to pick the smaller link in the lower left corner of the login box. 

Q. How was this software chosen?

A. In spring 2018 the University of Toledo began a selection process for Research Administration Software. The goal including documenting the process from the statements of needs to the evaluation and recommendation.  The scope of functionality sought in one or more products covered the following areas:  


COMPLIANCE:  preparation, development, submission, review, renewal, and amendment of protocol applications for human subjects research, animal research, and biosafety-relevant research

SPONSORED RESEARCH: grant proposal preparation, budget development, proposal submission, award creation, and tracking

A committee with representation from all affected areas was created.  The process of documenting needs from all areas above resulted in a very detailed Request for Proposals, and responses from vendors followed by an extensive process of review with follow-up demos.  The recommendation was to proceed in phases, with IRB Manager chosen to fill the needs for IRB, IACUC, and IBC protocols, i.e. the major compliance areas.  We expect to make announcements in early 2019 about the path for managing the sponsored research areas.

I have questions that are not answered here. Whom shall I contact?

Questions about using the product or about the IRB Protocol process should be directed to the HRPP staff.

Questions on the implementation of IRB Manager for compliance modules should be directed to Rick Francis, Director of Research Advancement and Information Systems, at rick.francis@utoledo.edu, or at 530.2936.

Last Updated: 12/10/19