Researchers seeking Froedtert Health Administrative Approval for their research should submit the Request for Froedtert Health OCRICC Administrative Approval Application
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.
Froedtert Health OCRICC Required Documents
- Informed Consent Form (prefer MCW or CIRB, will accept Sponsor template)
- Schedule of Events identifying items/services as Research versus Standard of Care
- 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 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.