Page 184 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Appendix A - Initial Email notification to the Research Team
Good morning/afternoon _________________,
Research Administration SOP No: Q004
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process
On ____________, I received notification of your new study referenced in the subject line. I will be your primary point of contact for PSA.
Please see the attached review Workbook based upon initial evaluation of your study. 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 send back 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 I do not hear back from you within 90 days, I will close your file and you will have to resubmit for Children’s PSA. Please let me know if you have questions/concerns.
With regards,
Assigned QS Reviewer Cc: QS Team Members
*Include Appendix A email notification
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