Researchers seeking Froedtert Health Administrative Approval for their research should submit the Request for Froedtert Health OCRICC Administrative Approval Application. You will be contacted once the project is logged with key information about the assigned OCRICC staff and the status of operational and financial feasibility review.

Researchers should not submit their application until all pertinent study documents are available for OCRICC review. A list of OCRICC required documents can be found below. We also have several guidance documents that provide additional assistance related to the process.

Completion of this application and attaching all required documents will support OCRICC’s timely and efficient operational and financial feasibility review. A project cannot be submitted without all required documents.

NEW JULY 2023: OnCore Financials Implementation: MCW is defining new projects as those that have not yet initiated any pricing/budget components as of 7/10/23. See MCW guidance memo for additional details on exception request process through MCW Office of Research (OOR).

New Projects Utilizing OnCore Financials — Froedtert Health OCRICC Required Documents

  • Protocol
  • Informed Consent Form Draft is acceptable (MCW site template preferred). Costs section must align with what is reflected in the OnCore CA Billing Grid designations as research paid versus billing as standard of care.
  • Schedule of Events no longer required, replaced with a signed off OnCore Billing Grid
  • FDA Approval Letter (Un-redacted; IND, IND exempt, or IDE trials only)
  • CMS Device Approval Letter (IDE studies only)
  • Completed Operational Feasibility Planning Tool
  • Imaging Manual or Guidelines (when applicable, for each imaging modality)
  • Echocardiography Manual (when applicable)
  • Device Manual/Instructions for Use (IDE trials only)
  • Surgical Guide (when applicable)
  • Staff Training Materials (when applicable)

Projects with OnCore Financials exception through MCW OOR — Froedtert Health OCRICC Required Documents

  • Protocol
  • Informed Consent Form in its final negotiated state, i.e. the ICF version that will be submitted to the IRB
  • Schedule of Events identifying items/services as Research versus Standard of Care
    Also acceptable:
    • Comparable documentation of R vs SOC
    • Detailed statement of what is R vs SOC (word document or other)
  • FDA Approval Letter (Un-redacted; IND, IND exempt, or IDE trials only)
  • CMS Device Approval Letter (IDE studies only)
  • Completed Operational Feasibility Planning Tool
  • Imaging Manual or Guidelines (when applicable, for each imaging modality)
  • Echocardiography Manual (when applicable)
  • Device Manual/Instructions for Use (IDE trials only)
  • Surgical Guide (when applicable)
  • Staff Training Materials (when applicable)

The Froedtert Health OCRICC Approval Application will allow researchers to save their work & come back to facilitate a complete submission. When this occurs, the researcher will be prompted with a message and link from the system on how to access their incomplete application when ready to submit. Researchers must retain this information; Froedtert Health OCRICC will not retrieve incomplete applications from the system.

OCRICC facilitates compliance with the regulatory requirements that apply to Froedtert Health entities regarding investigational drugs and/or medical devices, including completion of a Medicare Attestation Form at the time of Medicare Coverage Analysis (MCA). Froedtert Health OCRICC is not responsible for compliance with the regulatory requirements that apply to MCW Professional Services.