Cancer Center: Working with ePRMS and ARROW

New Studies, Major Amendments, Non-Major Amendments (including Expedited Changes)

What is the first step in submitting a new study or major amendment that needs PRMC and IRB review?

Study teams must first enter the new study or major amendment into ePRMS before submitting an application to the IRB via ARROW.  Non-major amendments are NOT entered in ePRMS and are sent directly to the IRB via ARROW.

Can study teams work on preparing the IRB application in ARROW while PRMC review is pending?

Yes. Study teams may prepare the IRB application in ARROW while PRMC review is pending. Study teams should not submit the application until PRMC approval has been received by the study team.  If the IRB application is submitted prior to the PRMC Approval, PRMC will issue a Deferral in ARROW, meaning the PRMC decision is deferred pending PRMC review and approval.

When can the IRB application in ARROW be submitted?

The study team can submit the IRB application in ARROW after they receive PRMC approval.

Does the study team need to upload a copy of the PRMC approval letter with the IRB application?

No. The PRMC coordinator will upload the PRMC approval letter in to ARROW.

How should the study team inform the IRB office of any specific review timeline requests (e.g., funding issues, 90 day deadline)?

If study teams have specific requests about review timelines, these must be noted in the comment box found in the Submit activity form.

What if the study team forgets to include a comment in ARROW about review timeline requests?

If the study team forgets to include a review timeline request in ARROW when submitting the application, the study team must contact the assigned IRB staff reviewer via email to communicate the request.

Determinations about review priority are made at the discretion of the IRB Office.

What happens after the IRB application is submitted in ARROW?

If submitted appropriately (i.e. after PRMC Approval has been received), ARROW will automatically forward the application to the PRMC without review by the IRB Office. The PRMC coordinator will then upload the PRMC approval letter in to ARROW. After the PRMC approval has been uploaded, the PRMC coordinator will forward the application to the IRB Office and the IRB pre-review process will begin.

What if CRU review also is required?

At the same time ARROW forwards the application to the PRMC, ARROW also will forward the application to the CRU, formerly known as CTRC. CRU review and the uploading of the PRMC approval letter will occur at the same time. Both CRU review and uploading of the PRMC approval letter will be completed before the application is forwarded to the IRB office for IRB pre-review.




Keywords:UWCCC, PRMC, Protocol Review and Monitoring, ePRMS, Cancer Center, major amendment   Doc ID:17457
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-24 18:00 CSTUpdated:2017-12-05 09:39 CST
Sites:Health Sciences IRBs
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