Process Flowchart: Medical School/OACA Clinical Research Sunrise Committee Process

PIs and research teams begin to formulate their Portfolio Plans in consultation with their Medical School department head or OACA center/unit/institute director by completing the Narrative Form and Data Form. This is an iterative development and review process within each department, division, center, institute, and/or unit. Medical School department heads or appropriate OACA center/institute/unit directors must sign off on Portfolio Plans to ensure concurrence.

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Once the Portfolio Plan is approved at the Department/Center level:

The PI or research team submits their Portfolio Plan, including documentation of the Medical School department head or OACA center/institute/unit director concurrence via the Clinical Research Sunrise Form.

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The Clinical Research Sunrise Committee reviews the Portfolio Plans. PIs and research teams should expect an iterative review process.

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The Clinical Research Sunrise Committee recommends approval by VP/Dean Tolar and Vice Dean Schacker. Letters of support for Portfolio Plans will be sent to the PI/research group.

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After PIs/research groups receive documentation of support for their Portfolio Plan:

  • The PI/research group must submit their letter of support for the Portfolio Plan to the IRB; OVPR/HRPP/IRB will need to sign off on any plan to resume a clinical trial or clinical research.
  • PIs and staff must submit any necessary return to work forms based on the Sunrise Step. Each employee should route their form to the PI, and PIs should route the forms to the Medical School department head or OACA center/unit director for final approval/sign-off.