Page 193 - 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
Good afternoon, Dr. ______________________________ I hope you both are well.
On ____________________, I received notification of your new study referenced in the subject line. I will be your primary point of contact for Children’s 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. Since this is a reliance study with _________________, also attached is our ePSA form to be completed and returned 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. IfIdonothearbackfromyouwithin90days,Iwillcloseyourfileandyouwill have to resubmit f or Children’s PSA. Please let me know if you have questions/concerns.
Best regards, Quality Specialist
Appendix E – Performance Site Approval Request to Medical Director
SOP No. 9: 12-20-2018; 02-17-2021; 08-25-2021;