WIRB Other Guidance

Other guidance for using WIRB



Submission Guide

The table below provides guidance about how and to whom certain actions and documents are communicated.

Type of Action or Document 


Send Email to submitwirb@medicine.wisc.edu


 Send Email to clientservices@wirb.com


WIRB Connexus


 

Initial Review

 

WIRB Eligibility  Worksheet

Yes 

No 

No

Initial Review Submission 

No

 No

Yes

Requesting Reconsideration Corrections 
(WIRB errors) 

No 

Yes 

No

 

Change in Research 

 

 PI Initiated Change in Research

Yes 

No 

Yes

Accepting "On Behalf" Change in Research 

Yes 

 No

Yes

 Declining "On Behalf" Change in Research

No 

 Yes

No

Administrative Change 

 No

No

Yes

Addition of Key Personnel 

Yes 

No 

Yes

IND Safety Reports 

No 

No

Yes

IDB updates 

No 

 No

Yes

Requesting Reconsideration Corrections
(WIRB errors) 

No 

 Yes

No

 

Site Progress Reports 

 

 Site Progress Reports

No 

No

Yes

 

Reportable Events 

 

 Reportable Events

No 

Yes

Yes


Study Closure

Closing Study

No

No

Yes




Study Closure

Study Teams are required to close their studies with WIRB when the sponsor directs them to do so or they will no longer be actively involved in the study (e.g., no subjects will be enrolled).  Follow the steps below to close a study with WIRB:
  1. Log into WIRBConnexus "Workspace Sites" to locate the approved WIRB study.
  2. Select "Add New Submission" within the "IRB Submissions Site Workspace" and scroll down to and select SmartForm for "Study Closure".
  3. When prompted to enter the "Submission Name", include the UW tracking number first, followed by date of the action request.
  4. Upload any applicable associated documents.
  5. Allow PI and sponsor document review time.
  6. Click Submit.
Please note: do not email submitwirb@medicine.wisc.edu when study closures are being submitted.

"Compassionate Use" / Expanded Access

For guidance regarding situations involving use of a drug or device, such as on a "compassionate use" basis or that differ from the approved protocol, please contact the WIRB Gateway Team before proceeding.


CRU and the Initial Review Application

Many research studies reviewed by WIRB also involve the use of the UW's Clinical Research Unit (CRU).  Study teams may apply to the CRU before or after they submit to WIRB.  A possible drawback with sending the initial review application to WIRB prior to CRU approval is that the CRU may request changes to the study materials not reflected in the submission sent to WIRB, which need to be addressed later via a change in protocol, which will result in a further fee.


Please note these additional special requirements for studies that use the CRU:
  • An information sheet is required and must be separate from the consent documents.
  • The CRU requires that they be included as an additional Point of Contact on the WIRB application form.  WIRB will copy the CRU on all communications and approvals and use the required margins for the consent documents.
For any questions about the CRU, contact:

Danielle Gale
CRU Protocol Manager
Clinical Research Unit (CRU)
600 Highland Ave, D6/621
Madison, WI 53792-6736
wirb-ctrc@uwhealth.org
(608) 262-3005



    WIRB and the Protocol Review and Monitoring Committee (PRMC)
    All studies that involve cancer patients or are designed for cancer research are required to have PRMC review and approval prior to submitting to WIRB.

    Use the WIRB Eligibility Worksheet to determine whether the study can be reviewed by WIRB before submitting to the PRMC.  A letter/email from the PRMC is required as part of the initial review submission as well as changes in research (CIR).  The UW WIRB Reliance Team will not process these studies without the PRMC documentation.


    For more information about the PRMC and its procedures, please refer to the Carbone Cancer Center (UWCCC) Protocol Review and Monitoring Committee (PRMC).


    See also:

    Initial Review Guidance for WIRB Submission

    Change in Research Guidance for WIRB Submission



    UW-Madison WIRB Fees Policy
    IRB Fee Policy

    Billing Process
    • Study teams are asked to complete the WIRB Billing Information Sheet and the UW-Madison Institutional Compliance Review Sheet.
    • WIRB sends an invoice to party listed on the WIRB Billing Information Sheet.
    • The Institute for Clinical & Translational Research (ICTR) will invoice for the UW-Madison Institutional Compliance Fee based on the information contained in the UW-Madison Institutional Compliance Review Sheet
    Please direct all WIRB fee questions to Faye Levine, flevine@medicine.wisc.edu, 263-4922.



    Tracking on WIRBConnexus






    Keywords:guidance, CTRC, CRU, PRMC, reconsideration, fee, invoice, re-consideration, tracking, charges, cost, cancer, compassionate, closure, close out, expanded access, WIRB Connexus   Doc ID:22507
    Owner:Mike B.Group:Western Institutional Review Boards
    Created:2012-02-01 16:14 CDTUpdated:2015-08-31 09:01 CDT
    Sites:Western Institutional Review Boards
    Feedback:  18   18