RASCAL IRB (Research Administration System for Compliance and Awards at Lurie Children’s)
The Office of Research Integrity and Compliance (ORIC) will provide updates to inform the research community about progress on implementation of RASCAL IRB, the new IRB platform that replaces Cayuse IRB as of January 27, 2025. With this new system, we look forward to streamlined processes, enhanced features, and a smoother, more intuitive user experience.
To transition out of Cayuse IRB efficiently, submission stop dates will be implemented for initial, renewal, and modification applications in Cayuse IRB so that no submissions are under review by the IRB at the time of data migration. This means that no new submissions will be processed in Cayuse IRB after the respective dates for IRB submissions indicated below. For urgent submissions or questions about items that were not submitted prior to the dates below, please contact IRB@luriechildrens.org for guidance.
RASCAL IRB Library
All supporting material for RASCAL IRB is available within the module's library. Please log into RASCAL IRB to access these materials, including: SOPs, investigator manual, templates, worksheets, and checklists.
Important Dates
- RASCAL IRB Implementation: January 27, 2025
Submissions are no longer being accepted in Cayuse IRB. Please contact IRB@luriechildrens.org with questions.
Cayuse IRB Accessibility
Cayuse IRB will remain accessible to study teams to access previous IRB records. If you do not currently have your IRB documents downloaded from Cayuse, create a plan to download and archive these materials before August 2025. More information about the transition out of Cayuse IRB will be provided when available.
Super User Groups
The RASCAL IRB super user groups are currently reviewing the new system and providing feedback on the materials and processes we create. The groups are made up of CRP and BRP volunteers, clinical research managers, and SCHORE managers.
RASCAL IRB Resources
- RASCAL IRB Drop-In Sessions will be held daily following implementation.
- View the Research Resource Hub event calendar
- RASCAL IRB SharepPoint Site
- Protocol templates and system walkthrough videos
- RASCAL IRB RP Townhall presentation, November 2024
- RASCAL IRB REAL Training, January 9, 2025
- RASCAL IRB Roadshow: If you are Interested in having a RASCAL IRB intro presentation at a division or staff meeting in January, please contact IRB@luriechildrens.org to schedule.
- Upcoming RASCAL IRB Roadshow events:
- Emergency Medicine, January 15, 9:30 a.m.
- IDS Pharmacy, January 24
- Surgery: February 17, noon
- Upcoming RASCAL IRB Roadshow events:
Active non-exempt protocols and external reliance protocols approved by the IRB will be migrated to RASCAL IRB.
ORIC will work with research teams on the completion of pending submissions for non-exempt research and external reliance protocols prior to the date of data migration. Submissions that are not yet finalized prior to implementation of RASCAL IRB will need to be resubmitted in RASCAL IRB.
Upon your first submission in RASCAL IRB (Continuing Review or Modification), you will be requested to follow protocol guidance to possibly update to the new protocol templates. If your study is still actively enrolling or conducting protocol activities, you may need to create a local site supplement or create a protocol document if only the Cayuse IRB application was previously used.
A decision tree with protocol guidance will be released in early January, 2025, to assist. Templates will be provided and a crosswalk to Cayuse IRB can be used to assist in ensuring all information is migrated. If your study is in data analysis only, new protocol templates will not be required.
Updated consent templates will only be required for new studies in RASCAL IRB after release of the new forms.
If your study expires in December and a renewal has not yet been submitted in Cayuse IRB, please contact IRB@luriechildrens.org for guidance. What if my study can be closed?
If your study activity is completed, please submit a closure in Cayuse IRB as soon as possible.
ORIC will work with research teams on the completion of pending submissions for non-exempt research and external reliance protocols prior to the date of data migration. Submissions that are not yet finalized prior to implementation of RASCAL IRB will need to be resubmitted in RASCAL IRB.
Urgent submissions, such as emergency use, submissions with funding implications, compliance concerns, etc. can still be submitted during the blackout dates. If you have an urgent submission during this time, please contact IRB@luriechildrens.org to alert the IRB for the need to review and obtain further instructions.
Urgent submissions, such as emergency use, submissions with funding implications, compliance concerns, etc. can still be submitted during the blackout dates. If you have an urgent submission during this time, please contact IRB@luriechildrens.org to alert the IRB for the need to review and obtain further instructions.
Studies determined to be Exempt in Cayuse IRB will not be migrated to RASCAL IRB. If your Exempt study is changing, submit a new Exempt study in RASCAL IRB following the Exempt protocol template. Changes that would require review include participant facing material changes and protocol revisions that may impact the Exempt determination of the study.
ORIC will host daily drop in hours for assistance with RASCAL IRB the week of January 27, 2025. Additional drop in hours will be held in the following weeks.
