If your research project is using any Froedtert Health resource, your project requires administrative approval granted through OCRICC.

As of Oct. 19, 2017, Category 8 Registration Projects no longer require OCRICC review and approval but do still require completion of an Accounting Log. Learn more about the PHI process.

The instructions below outline the required forms and information on next steps.

1. Complete an OCRICC Project Application Form

We strongly encourage research staff to complete and submit an OCRICC Project Application Form and other required information as soon as you know that your project will move forward. If an OCRICC Project Application Form is submitted later than your IRB Application, there may be a delay to obtain your final administrative approval from Froedtert Health.

An OCRICC Project Application form is also required if the researcher is only seeking project feasibility data, pricing, or questionnaires to be completed for Froedtert services, as well as for pilot or grant award applications. Complete the form with all information available at the time. Enter “TBD” or “Not Available” if the information is not known.

The Project Application Form will allow you to identify the key details of your research project. Based on the information you provide on the application form, you may be asked to complete additional forms or provide additional information or documents.

The Application Form allows up to 10 documents to be uploaded for OCRICC review. Key documents to include with your submission:

 

  • Protocol
  • Schedule of events indicating SOC vs. Research charges
    • Services may be billable to the patient’s insurance or may be paid for by a grant/industry sponsor
  • Informed Consent (even if only in draft form)
  • Imaging manual
  • Lab Manual
  • Clinical Trial Agreement (if pertinent to FH)

Complete the Project Application

As of Nov. 30, 2017, the PHI Checklist has been absorbed into the Project Application Form. To ensure compliance with the HIPAA Privacy Rules, OCRICC will validate as part of our review the intended use of PHI for your project, and upon notification IRB approval, validate granted access and provide the proper instructions for use and disclosure of FH PHI for research purposes. Learn more about the PHI process.

2. Complete the Appropriate Medicare Attestation Forms

The appropriate Medicare Attestation Form must be completed by the investigator if the project involves billing the investigational drug or device to the patient/patient’s insurance.

Complete the Drug Form and/or Complete the Device Form

OCRICC facilitates compliance with the regulatory requirements that apply to FH entities regarding investigational drugs and/or medical devices. These requirements may also apply to the Professional Services, for which OCRICC is not responsible.

Learn more about the requirements >>

3. OCRICC Review of Application and Documents

Upon receipt of the project application form and documents, OCRICC will perform a financial/operational analysis for all resources that FH is being asked to provide. OCRICC facilitates:

 

  • Pricing and discounting of services that are being invoiced to the study as a research cost, including validating whether the research sponsor will provide any investigational product for free
  • Performing a Medicare Coverage Analysis for any services you indicate to be billed as standard of care, and
  • Reviewing the Clinical Trial Agreement (if pertinent to FH)

OCRICC will also facilitate operational feasibility discussions between the appropriate FH clinical business leaders, their staff, and the research team in order to obtain FH support and commitment. FH leaders must determine whether they can provide/perform the resources requested for the lifetime of each research project because departments and service areas are staffed based on clinical volume and have limited access to additional staffing or space. If your project intends to enroll at multiple FH locations, OCRICC will facilitate any necessary discussions across the FH system.

You will be contacted by the assigned Nurse Consultant and receive more information on operational and financial feasibility as we review your application.

Next Step: Learn about the OCRICC Review Process >>

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