Page 221 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q009
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
Appendix A – Initial Integrify® automated email to Research Team with completed Workbook:
Hello _________________,
I received notification of your new study referenced in the subject line. I will be your primary point of contact throughout the Children’s PSA process.
Please see the attached review workbook based upon initial evaluation of your study. There are a number of tabs in the workbook. Depending on the project, there are a number of tabs in the workbook. Please review each tab for any noted requests and checklist items highlighted in yellow. They must be sufficiently addressed before PSA can be issued. Please respond to the requests in your IRB submission (where appropriate), note your responses in the workbook, and return to me.
If the study changes in any way during and/or after the IRB review process, please let me know so I can review those sections again to determine any if anything additional will be needed before PSA is issued.
I look forward to working closely with you to get your study opened as expeditiously as possible. If a response has not been received from you within 90 days, I will close your file will be closed, and you will have to resubmit for Children’s PSA. Please let me know if you have questions/concerns.
With regards,
Quality Specialist Reviewer
Appendix B – Performance Site Approval Request to Medical Director
To: Jeffrey Kahn, M.D., Medical Director
Subject: CHILDREN’S HEALTH – PERFORMANCE SITE APPROVAL REQUEST
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