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.

New in 2019: This application should not be submitted until all applicable and necessary 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.

Froedtert Health OCRICC Required Documents

  • Protocol
  • Informed Consent Form (prefer MCW or CIRB, will accept Sponsor template)
  • 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 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)
*New in 2019: The Froedtert Health Operational Feasibility Planning Tool is an OCRICC required document to be completed and submitted at time of application, in addition to all other project-related documents.

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.

As of July 1, 2019, the Medicare Attestation Forms have been retired. OCRICC facilitates compliance with the regulatory requirements that apply to Froedtert Health entities regarding investigational drugs and/or medical devices and will absorb this into the Medicare Coverage Analysis (MCA) process. Froedtert Health OCRICC is not responsible for compliance with the regulatory requirements that apply to MCW Professional Services.
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