Clinical Research Unit (CRU) Requirements

Usage of the Clinical Research Unit (CRU) with WIRB

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
(608) 262-3005

    Keywords:CTRC, PIR, clinical research unit   Doc ID:22509
    Owner:Mike B.Group:Western Institutional Review Boards
    Created:2012-02-01 15:29 CSTUpdated:2016-04-18 07:48 CST
    Sites:Western Institutional Review Boards
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