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STEPS TO STUDY ACTIVATION

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Request Approval from IU Health Ambulatory Surgery Center

Research occurring within one of IU Health’s Ambulatory Surgery Centers (ASC) must receive approval by the ASC Clinical Director before the project begins. 

A policy established by the IU Health Ambulatory Surgery Centers requires physicians, nurses, and other researchers to seek approval for any research study for which procedures will take place within one of the IU Health ASCs. Following submission to the Office of Clinical Research, the researcher, or a member of the study team, should initiate this approval process as outlined in the Research in Ambulatory Surgery Centers Policy.

The Approval Process

    1. The researcher, or a member of the study team, should complete the top portion of the IU Health ASC Clinical Research Request Form and submit it to the Office of Clinical Research (OCR) at ocrfin@iu.edu after all policy requirements have been met.
    2. The OCR Financial Compliance team (or their delegates in the IUSCCC Adult Clinical Trials Office) will review the clinical research billing requirements and when applicable, enable OnCore consent notifications to be received by the Surgical Care Affiliates (SCA).
    3. The OCR Financial Compliance team, or their delegates, will complete their portion of the request form and send it to the ASC Clinical Director once research billing compliance implications have been identified and documented as appropriate.
    4. The Clinical Director of the ASC will review the ASC Clinical Research Request Form to ensure all criteria specified in the policy have been met. If approval is granted, the ASC Clinical Director should return the signed request form. 
    5. The Clinical Director will communicate the approved research project criteria to the Medical Director(s) and Clinical Manager(s).

Available Resources

For policy questions, contact ClinResearchOps@iuhealth.org. 

Requesting approval from the IU Health Ambulatory Surgery Center is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap