Researchers seeking Froedtert Health Administrative Approval for their research should submit the Request for Froedtert Health OCRICC Administrative Approval Application
- Research Pricing Guidance
- Operational Feasibility Determination Guidance
- Medicare Coverage Analysis Guidance
- Informed Consent Guidance
- OCRICC 101 Guidance for Research Teams
- OCRICC 101 Guidance for Froedtert Health Leaders
- Research Paid Services and Preauthorization Guidance
- Community Locations and Service Availability — Feasibility Planning Tool for Research Teams
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.
Office Location
Froedtert Hospital Campus
9200 W Wisconsin Ave
Milwaukee, WI 53226
Pavilion Building, 3rd floor