Page 188 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q010
SOP Title: Performance Site Approval Process For External IRB-Approved Research Projects
Elements of Children’s External Performance Site Approval (ePSA) – Workbook Documentation
• Assigned QS reviewer will assess the study staff in the ePSA for verification of CMC credentialing / required research training.
o WorkbookDocumentation-Identifiescredentialing/trainingdeficienciesand provides contacts for completion of any staff credentialing deficiencies.
o Workbook Documentation – Assigned QS reviewer will assess all patient facingdocumentstoensureconsistencywiththestudyprotocol.Discrepancies will be noted and questions will be formulated if concerns are identified following review of all study documents.
o Workbook Documentation – For projects with required ancillary services, assigned QS will document lab/pathology support, IDS services, and any other ancillary services support in the workbook.
o Workbook Documentation – For projects requiring assistance from 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 Workbook Documentation – For projects where patients ≥ 19 years of age 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 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.
SOP No. 9: 12-20-2018; 02-17-2021; 08-25-2021;