University of Wisconsin–Madison

CRU Protocol Application

1. Before Submitting a CRU Application

If you plan to use the CRU, you should submit a CRU Consult Request at least one month before you submit your IRB application. We will not accept requests for feasibility reviews or perform Ancillary Service Reviews until a CRU Consult has been submitted. There is no charge for this service. Charges only apply to industry studies upon submission of a CRU Application.

2. Determining CRU Nursing Procedure Charges for an Industry Budget

If your application is industry-sponsored, the CRU has developed documents to assist you in selecting the correct CRU procedure charges when you are developing your study budget. The UWHC also has a document to assist you in determining infusion and injection charges. See Budgeting Toolkit for Industry Studies for these documents.

3. CRU Fees for Industry Studies

For new industry-sponsored studies, make sure to include the CRU Proposal Review and Implementation fee in your budget. This fee will be assessed against study accounts upon CRU protocol approval. The standard fee is $1,250 for CRU protocols in which subject status (inpatient or outpatient) does not change during the study. For a $1,500 fee, studies have the option of scheduling subjects as inpatients or outpatients, depending on patient or study needs.

The CRU also assesses fees for amendments, or for rush implementation of study or amendment initiation. Please make sure to account for these potential charges in your study budget. For details on these fees, refer to the CRU Fees for Industry Funded Studies (PDF) document.

4. CRU Review Process and Meeting Dates

The CRU Protocol Implementation Review (PIR) group meets twice monthly, usually on the 1st and 3rd Tuesdays of each month, to evaluate applications from investigators who want to use the CRU. The PIR consists of an MD-Core director from ICTR; an MD-research subject advocate; the CRU nurse manager, care team leader, and advanced practice nurse practitioner; and administrative bionutritionist staff. In addition, there are representatives from the UWHC Pharmaceutical Research Center and UWHC Clinical Laboratories.

The following are CRU PIR meeting dates for 2017. As of September 2016, meetings will now be held the 2nd and 4th Tuesday of the month. The deadline for receipt of both the electronic copies and paper copies by 12:00 noon one week prior to the PIR meeting.

2017 Meetings:
Tuesday, January 24
Tuesday, February 14
Tuesday, February 28
Tuesday, March 14
Tuesday, March 28
Tuesday, April 11
Tuesday, April 25
Tuesday, May 9
Tuesday, May 23
Tuesday, June 13
Tuesday, June 27
Tuesday, July 11
Tuesday, July 25
Tuesday, August 8
Tuesday, August 22
Tuesday, September 12
Tuesday, September 26
Tuesday, October 10
Tuesday, October 24
Tuesday, November 14
Tuesday, November 28
Tuesday, December 12
(no meeting Tuesday, December 26)

5. CRU Applications

For CRU applications, you must include a completed application and in information sheet(s) in your IRB application.
Download the application here: CRU Application/RSA Worksheet (Word Doc)

6. How Do I Determine if a Study Visit on the CRU would be Considered an Outpatient Visit or an Inpatient Admission?

A CRU Outpatient Visit is a study visit that takes place on the CRU with a duration of less than 10 hours, and the study visit does not go past 9:00 PM. CRU Outpatient Visits that are expected to be 10 or more hours in length or that will extend past 9:00 PM must be submitted as CRU Inpatient Admissions, and the subject should expect to stay the night following the study visit.

[The study visit time starts at the point that the research subject arrives at the CRU and ends at the time they are discharged and leave the CRU. If your study requires lab results before treatment can be initiated or study drug can be ordered, this should also be taken into account. (For example, standard turnaround time for routine medication orders by UWHC Pharmacy is ~2 hours.)]

A CRU Inpatient Admission is typically a study visit that requires the subject to stay overnight. In addition, study visits that exceed 10 hours in duration or that will extend past 9:00 PM require an inpatient admission (see above).

Any questions on whether a study requires inpatient admissions or outpatient visits should be discussed with CRU staff at the Consult meeting.

7. Where Do I Submit my CRU Application?

  • For Applications using ARROW:
    To indicate this study is using the CRU, check “Yes” for 17.4 “Will this study use the Clinical and Translational Research Research Core (CTRC)?” Now named CRU, our hospital unit is still part of the CTRC. Then, upload the CRU Application/RSA Worksheet under Supplemental Information, Section 2.1 (where ARROW asks for the CTRC application). When you submit your completed IRB application, the ARROW program will forward your application for review by the CRU Protocol Implementation Review group.
  • For WIRB submissions (Western Institutional Review Board):
    It is recommended that CRU review occur prior to the formal WIRB submission to avoid additional fees for any changes requested following CRU PIR review. Please submit electronic copies of the full application [CRU application, WIRB application (if application has been submitted to WIRB), protocol, consent, information sheet, HIPAA, other documents (e.g., investigational drug brochure)] by email to Danielle Gale dgale@uwhealth.org. In addition, submit 4 paper copies as described below. Please make sure that CRU has been included as a second point-of-contact in the Study Coordinator section of the WIRB application (CRU Danielle Gale, wirb-ctrc@uwhealth.org) so CRU can directly receive notification of approvals and amendment submissions from WIRB (multiple contacts are allowed).
  • For UWCCC applications using the National Cancer Institute Central Institutional Review Board (NCI CIRB) Independent Review Model:
    CRU review is recommended prior to submission. Review concurrent with PRMC review is suggested. Please submit electronic copies of the full application [CRU application, NCI CIRB application (if application is complete), protocol, consent, information sheet, HIPAA, and any other pertinent application documents (e.g., investigational drug brochure)] by email to Danielle Gale dgale@uwhealth.org. In addition, submit 4 paper copies as described below. Please refer to the HS-IRB’s KnowledgeBase page for additional details about the NCI CIRB review process.
  • For studies using the Wisconsin IRB Consortium (WIC):
    It is preferred that CRU review occur prior to submission. Please submit electronic copies of the full application [CRU application, WIC application (if application is complete), protocol, consent, information sheet, HIPAA, and any other pertinent application documents (e.g., investigational drug brochure)] by email to Danielle Gale dgale@uwhealth.org. In addition, submit 4 paper copies as described below. Please refer to the HS-IRB’s KnowledgeBase page for additional details about the WIC review process.

8. Paper copies

Once you have submitted your CRU application, please deliver 4 stapled, double-sided copies (if possible, please staple all sections into one document, do not staple individual sections) of the following documents in the order listed below to the CRU Administrative Office (D6/619, CSC).All documents should be clean/untracked versions, when possible.

  1. CRU Application/RSA Worksheet (signed)
  2. The IRB initial review application (ARROW, WIRB, NCI CIRB, WIC)
  3. The most current sponsor protocol/grant application. (If you need to create a protocol document, it should follow the guidelines described in the HS-IRB’s Protocol Guidance site.)
  4. Draft Consent Form(s), Assent(s), Information Sheet(s), HIPAA(s)
  5. Other documents needed for review [e.g., PI biosketch (if a new investigator to CRU), RSP-approved budget, other pertinent documents, etc.]

Other attachments provided to the IRB (e.g., Investigational Drug Brochure/IDBs, questionnaires and forms completed by study staff, IND information, etc.) only need to be provided electronically

Publications arising from any research project receiving support from the UW ICTR, regardless of funding source, must acknowledge support by stating:

“The project described was supported by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.”

PLEASE NOTE: ICTR support includes not only direct fiscal support such as funding for pilots, but also ICTR resources like scientific editing, use of the Clinical Research Unit, CRU consults, ICTR Scientific Review Committee review, and consultations in biostatistics.