Page 182 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q004
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process
• During review, the assigned QS reviewer will complete a PSA review Workbook, documenting questions and requests.
• Following completion of the Workbook, the assigned QS team member will send the completed Workbook to the research team via (Integrify) a template email (Appendix A) and request responses to the highlighted sections of the attached Workbook.
• It should be noted that some researchers submit their IRB applications concurrent to performance site review request in Velos. For those who do not submit a PSA request in Velos, documentation will be noted in the QS Workbook as a pending request. Following receipt of the PSA request in Velos, the assigned QS team member will update the PSA status to Performance Site – Received – Pending review’
• Assigned QS reviewer will create a study e-file and save all pertinent documents
and email communication in the network drive (X:\Quality Specialists\PSAs\PendingPSA\....) for future reference.
• QS logs the new study by entering it in REDCap and Integrify
• Following completion of performance site review and confirmation that are required elements of the review have been completed/documented, the project will be ready to submit to Dr. Jeffrey Kahn for performance site approval (Appendix B). Members of the research team will also be informed of CMC PSA with an email notification
(Appendix C).
Elements of Children’s Performance Site Review – Workbook Documentation
• Assigned QS reviewer will assess the study staff in the eRIB, Velos, and form B for verification of CMC credentialing / required research training
o Workbook Documentation - Identifies credentialing / training deficiencies and provides contacts for completion of any staff credentialing deficiencies
o Workbook Documentation - Requests for copy of DOA (for industry funded projects only), FDA 1572 (if required), NCT# (if required), IND letter (if required), and other documents (CRFs, MOP, Lab Protocol, Pharmacy Manual, IB, etc.)
o Workbook Documentation – Assigned QS reviewer will assess all patient facing documents to ensure consistency with the study protocol. 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 a AA request.
SOP No. 3, Date: 4/13/16; revised 5/3/16; 7/5/16; 8/2/16; 09/18/2017; 03/19/2018; 03/19/2019; 07/17/2020; 11/02/2020; 02/25/2021; 06/03/2021, 05/31/2022