WIRB Other Guidance

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 Submit to 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

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"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 Reliance Team before proceeding.

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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. Those changes would need to be addressed later via a change in protocol, which will result in further fees.

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
(608) 262-3005

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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).

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UW-Madison WIRB Fees Policy

The WIRB Fee Policy is available here.

The billing process proceeds as follows:

  1. Study teams are asked to complete the WIRB Billing Information Sheet and the UW-Madison Institutional Compliance Review Sheet.
  2. WIRB sends an invoice to party listed on the WIRB Billing Information Sheet.
  3. 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.
  4. Please direct all WIRB fee questions to Faye Lux, Fee/Funding Point Person at flevine@medicine.wisc.edu or 608-263-4922.

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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 WIRB Connexus "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.

NOTE: Do not email submitwirb@medicine.wisc.edu when study closures are being submitted.

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See Also:

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 15:14 CSTUpdated:2017-10-19 14:28 CST
Sites:Western Institutional Review Boards
Feedback:  18   19