Page 154 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q005
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 document requirement for completion of Adult Patient Recruitment form and the Children’s leadership committee decision regarding inclusion of adult patients.
o WorkbookDocumentation–Forprojectsthatutilizetechnologiesand 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 WorkbookDocumentation–ForprojectsthatrequireFacilityUse Agreement, assigned QS specialist will documentation date of initiation and execution of the agreement.
o WorkbookDocumentation-Forprojectswithresearchbillablepatient 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