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sIRB - UNMC process

The UNMC sIRB Process is captured in the diagram below.

sirb_process.png

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Step One: Request Determination

    Lead Site submits sIRB request through RSS sIRB Team sets up initial consultation with Lead Site Study Team sIRB Request Determination based on study team and HRPP resources, IRB expertise

    Step Two: Lead Site and Protocol Review

      Lead Site submits IRB application (protocol and lead site information) through RSS UNMC IRB, sIRB Team reviews the submission Lead Site Study Team works with the sIRB Team to resolve any outstanding items Protocol and lead site approved

      Step Three: Participating Site Review

        Participating Sites sent invitations to complete participating site application through RSS. Applications reviewed by sIRB Team Reliance Agreement negotiation and determinaion Site approved as each site fulfills requirements Final activation contingent on meeting institutional requirements

        Step Four: Study Maintenance

        Activities during the course of the study include:

          Change Requests Continuing Review Single Subject Deviations Incident Reports Adverse Events Completion Reports

          Contact sirb@unmc.edu with any UNMC sIRB process questions.

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