UROC FAQ’s
What do I need to submit for UROC review?
All studies enrolling UW Health Patients or occurring in UW Health facilities require UROC review. You can view the requirements for submitting a study for UROC review here.
What is the submission deadline for UROC review?
Our goal is to be expedient in our review process. You can view UROC submission deadlines and meeting dates here.
Can a study be submitted for IRB review in tandem with UROC review?
It is better to wait until after UROC review to submit your study to the IRB, because there may be details that you need to add to your study that come up during UROC review. In the meantime, you can still get everything ready to submit to the IRB; if you have already submitted the study for IRB review, we can still review your study. In the future, there will be a hard stop in IRB process if a study has not received UROC review and meets the requirements for review, however, since UROC is in the pilot phase that feature is not yet functional.
Where in the workflow will a study get flagged if it does not require UROC review?
UROC review is required for SMPH sign-off and prior to IRB review. Weekly reports will be run by the UROC Administrator to identify studies that need UROC review. To make sure your study receives a review, please review the instructions here.
How does the UROC Submissions Checklist differ from the SMPH Feasibility Checklist that is required as part of the UW IRB process?
The UROC process is in pilot until 12/31/2023 and at that time we will assess where we may be able to gain efficiency in the feasibility review.
If we are utilizing CRU for our study and not any other clinical nursing spaces, do we need to complete the UW Health Nursing Intake Form for Research (Form 3.11)?
If you are only using CRU Nursing Services you do not have to complete Form 3.11. Include your CRU consult and approval with your UROC submission.
How will a UROC Reviewer contact the PI/Study Coordinator if they have questions about the protocol they are reviewing?
The Administrative Coordinator will contact the PI/Study Coordinator if they have questions about a protocol or the protocol requires additional information.
If a protocol is approved to move forward and will require UWH IS resources, what does that process look like? Will the requester be notified to submit a SN request and attach supporting documentation that they have received UROC approval?
The process for requesting UWH IS resources will work the same as it does today, which is submitting a Service Now ticket.
If a study is already operational, does it need to go through UROC Review?
If a study is operational it is grandfathered in. Studies are grandfathered in if it was entered in OnCore prior to July 1, 2023.
When in the budgeting process should I submit a study for UROC review?
Your budget should be finalized prior to submitting a study for UROC review, when possible. If you anticipate that the budget will take a long time to get approved, you can submit an estimate but it is best that you have your budget completed.
Will funded studies need UROC operational feasibility review? Does the UROC review process include federal sponsors or is the review for industry sponsored proposals?
UROC review is not tied to the funding source of a study. Studies that meet the criteria for UROC review will need to go through the review process.
What if a study is more expensive than budgeted once it is submitted for UROC review?
If there are substantial changes to the budget UW CTI leadership will work with the study team. Please contact the UROC Administrator.
I am with UW Health and do not have NetID to access. How to I access the UROC KB page?
NetID is required to access the KB page. Please contact the UROC Administrator.
I need to submit a study into OnCore for UROC review but do not have OnCore training or access. How do I get this?
You will need to start on the OnCore Overview. This page includes info about what protocols are required to be in OnCore, and also has links to info about access and training.
With operational feasibility reviews being evaluated by UROC, would this replace the SMPH Attestation form through ICTR or is UROC in addition to it? Is it safe to say the UROC request would be first and after that approval it would then go to SMPH for feasibility review?
UROC review does not replace the SMPH Attestation form. UROC review is first, then the Research Feasibility Attestation Form, which needs to be submitted with the initial IRB Application. There will be continuing evaluation about how to streamline these forms and processes going forward.
Links
Required Studies / Exempted Studies
Learn more about what studies are required to undergo UROC review and those that are exempt. If you are unsure, please contact the UROC Admin.
UROC Meeting Cycle
Learn more about the UROC meeting schedule, submission deadlines, and review dates.
UROC KnowledgeBase
Find detailed instructions for submitters, committee reviewers, and committee members on the submission and review process for studies requiring UROC operational feasibility review.
Questions?
