Page 191 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q005
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
• During initial review, QS completes a PSA review Workbook (Appendix E) for documentation of the review, noting questions and requests / actions needed from the PI / PRC.
• After completing the Workbook, the QS enters the study in CHRA’s Integrify® data management system by completing the Initialization Form and the Intake Form, and QS attaches the Workbook to the Intake Form. Once the Intake Form is completed with the attached Workbook, an automated email is sent to the study team with the attached Workbook requesting 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 PSA status in Velos will be updated to ‘Performance Site – Received – Pending Review.’ For external IRB- approved projects, there will be no Velos update of the study.
• QS reviewer creates an electronic efile that contains all related documents and email correspondence in the network drive (X:\Quality Specialists\PSAs\PendingPSA\....) for future reference.
• Additionally, QS logs the new entry in REDCap.
• Following completion of performance site review and confirmation that all required elements of the review have been completed / documented, the project will be submitted to Children’s Medical Director for performance site approval (Appendix B). Members of the research team will be informed of CMC PSA with an email notification (Apppendix C).
• Upon IRB approval, completion of performance site review, and confirmation that all required elements of the review have been completed / documented, the project will be submitted to the Children’s Medical Director for performance site approval (Appendix B). Members of the research team will also be informed of CMC PSA with an email notification (Appendix C(1) and C(2)). For studies with no charges to be incurred, a No SOA Required word document is attached to the PSA notification email (Appendix D).
• Copies of templates are included in this SOP (Appendices A, B, C, D(1) and D(2), and E (Workbook)).
Elements of Children’s Performance Site Review – Workbook Documentation
• Assigned QS reviewer will assess the study staff in the eIRB, Velos, and eIRB SmartForm 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 WorkbookDocumentation–AssignedQSreviewerwillassessallpatient 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 WorkbookDocumentation–Forprojectswithrequiredancillaryservices, assigned QS will document lab/pathology support, IDS services, and any other ancillary services support in the workbook.
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