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.
How does the UROC Submissions Checklist differ from the SMPH Feasibility Checklist that is required as part of the UW IRB process?
If a UROC review is required, beginning on July 28, 2024, study teams must upload the UROC endorsement letter in the IRB ARROW page when prompted. Research will not proceed to IRB review without the UROC endorsement letter uploaded to the IRB submission. As UROC review functionally replaces the SMPH feasibility review, the current SMPH feasibility page is being removed at the same time. Study teams should work with their departments to determine if department leadership requires feasibility checklists to be submitted to their office.
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?
UROC review is required before a study can be submitted to the IRB. Once a study has gone through UROC review, study teams will receive an endorsement letter from UROC that will replace the SMPH Attestation form on the IRB ARROW page. The UROC endorsement letter will need to be submitted along with the IRB application.
The UROC 2024 Submission and Review Schedule will help teams plan their submissions accordingly. Teams should pay special attention to the notable dates for 2024 listed beneath the schedule.
If there is uncertainty about whether a study requires UROC review, researchers may review the UROC – Required Studies / Exempted Studies chart. If the research requires UROC review, requirements for submission are available on the UROC KB page.
Any questions about the UROC process may be directed to Stephanie Sanders at slsanders2@wisc.edu.
What is the submission deadline for UROC review?
Our goal is to be expedient in our review process. Before submitting your research for IRB review, plan to submit it for UROC review first. On the UROC KB Page, you can view the 2024 UROC Submission and Review Cycle and notable dates for 2024 at the bottom of the page.
Can a study be submitted for IRB review in tandem with UROC review?
It is better to wait until after the UROC review to submit your study to the IRB because there may be details you need to add to your research that come up during the UROC review. The UROC review process determines whether a protocol can be operationalized, and the review may have a recommendation that may change your protocol. Suppose UROC reviews the research before submitting it to the IRB. In that case, you will only have to submit the protocol to the IRB once because you have already incorporated any operational changes that may have required a protocol amendment if the IRB process occurred before UROC.
In the meantime, you can still prepare everything to submit to the IRB; if you have already submitted the study for IRB review, we can still review it.
How is UROC handling the review of research that needs IRB approval for NIH Just In Time (JIT) requests if UROC is a hard stop in the IRB submission process? We can indicate IRB approval is pending, but this can lead to delays in award issuance or funding restrictions pending IRB approval.
As soon as you receive a JIT request, please submit your research to UROC and indicate it is a JIT submission. The UROC review takes about ten days, and then it can go on to IRB.
When in the budgeting process should I submit a study for UROC review?
Ideally, your budget should be finalized before submitting a study for UROC review. However, 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 a complete budget.
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?
