CRU Protocol Application Process

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. Requests for feasibility reviews or Ancillary Service Report reviews will not be accepted 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.)

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 the Budgeting Toolkit for Industry Studies for these documents.

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.

CRU Applications

• All submissions require a completed CRU Application.
  Download the application here: CRU Application/RSA Worksheet (Word Doc)

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 a CRU Inpatient Visit, and the subject should expect to stay overnight.
  • [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 Visit 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 overnight visit (see above).
• Any questions on whether a study requires overnight inpatient visits or outpatient visits should be discussed with CRU staff at the Consult meeting.

Where Do I Submit my CRU Application?

• For Applications reviewed by the UW HS- or MR-IRBs:
  • In ARROW, indicate in the Scientific Review section that the study will use the Clinical Research Unit.  Upload the CRU Application/RSA Worksheet under the Supplemental Information section. When you submit your completed IRB application, the ARROW program will forward your application for review by the CRU Protocol Implementation Review group.For Applications submitted to an external/ceded (non UW-Madison) IRB (e.g., Western IRB/WCG, Advarra, NCI CIRB, etc.):

• For Applications submitted to an external/ceded (non UW-Madison) IRB (e.g., Western IRB/WCG, Advarra, NCI CIRB, etc.):
  • CRU review is recommended prior to the formal submission. Please submit electronic copies of the application materials described below by email to the CRU Protocol Team group email, cruprotocolteam@uwhealth.org and Danielle Gale, dgale@uwhealth.org.
    • CRU Application/RSA Worksheet (signed)
    • 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.)
    • Draft Consent Form(s), Assent(s), Study Summary/Information Sheet(s), HIPAA(s); this can be a combined document, as allowed by IRB
    • Data Monitoring Committee Charter, if applicable
    • Investigational Drug Brochure(s), if applicable
    • Patient drug diaries, if applicable
    • Pharmacy Manual, if applicable
    • Other materials the applicant believes are pertinent for CRU review
    • If this is the Principal Investigator’s first CRU application, also include a Biosketch (preferred) or Curriculum Vitae (CV)
  • When submitting applications to an external IRB in ARROW, indicate in the Scientific Review section that the study will use the Clinical Research Unit.

AS OF APRIL 2020, PAPER COPIES ARE NO LONGER REQUIRED.

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 UL1TR002373. 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.