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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q009
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
o WorkbookDocumentation–Forprojectsrequiringassistancefrom Advanced Analytics (AA) for EPIC screening reports or other report types, assigned QS reviewer will document requirements and provide guidance to the research team for submission of an AA request.
o WorkbookDocumentation–Forprojectswherepatients≥19yearsofage will be recruited, assigned QS specialist will provide guidance for Adult Patient Recruitment submission in C360, and QS will communicate to the study team the Children’s leadership committee decision regarding inclusion of adult patients.
o Workbook Documentation – For projects that utilize technologies and medical devices that interact with Children’s network, assigned QS reviewer will assess the device/technology and will provide guidance for Standard Review (SR) Assessment. A ServiceNow SR request will be required prior to PSA.
o Workbook Documentation – For projects that require Facility Use Agreement, assigned QS specialist will document date of initiation and execution of the agreement.
o Workbook Documentation - For projects with research billable patient charges and research services, documentation that an agreement will be needed is noted in the Workbook.
6. PROCESS MAP
SOP No: 03b – Date: 12/20/18 (Draft); 02/17/21; 02/25/21; 6/3/21; 6/9/21; 8/25/21; 6/03/22