Page 187 - 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
• Assigned QS team member reviews notification and emails Researcher as f ollows:
o QSsendsResearcheranIRBApprovalAgreement(IAA)/reliance agreement template (Appendix A) to be signed by the signatory for the external IRB and the signatory for Children’s Health;
o QSsendsResearchertheexternalPerformanceSiteApplication(ePSA) template (Appendix B) to complete. The ePSA provides a summary of the project, including any needed ancillary service lines need ed to conduct the study (such as IDS, Lab/Pathology, Radiology, etc).
o QSrequestselectroniccopiesofallexternalIRB-approvedstudy documents, including a Clinical Trial Cost Coverage Analysis (CTCA). For studies without a CTCA or similar document, assigned QS team member will update senior Research Administrators so that an internal CTCA determination may be performed to verify the payers in question.
• During initial review, QS completes a PSA review Workbook (Appendix C) for documentation of the review, noting questions and requests / actions needed from the PI / PRC.
• AftercompletingtheWorkbook,theQSentersthestudyinCHRA’sIntegrify®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, QS sends the New Study Acknowledement and Initial Review (Appendix D) to the study team with the attached Workbook requesting responses to the highlighted sections of the attached Workbook.
• 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.
• Quality Specialist(s) logs the new PSA notice in RedCap.
• Upon IRB approval, and f ollowing completion of performance site review and
confirmation that all required elements of the review have been completed / documented, the project is submitted to Children’s Medical Director for performance site approval (Appendix E). Members of the research team will be informed of CMC PSA via an email notification. For studies with billable charges, the SOA is attached and sent via email (Appendix F1). For studies with no charges to be incurred, a No SOA Required document is attached to the PSA notification email (Appendix F2).
• Copies of templates are included in this SOP (Appendices A, B, C, D, E and F1 and F2).
SOP No. 9: 12-20-2018; 02-17-2021; 08-25-2021;