Page 155 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
7. CHANGE HISTORY
Research Administration SOP No: Q005
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q005
12/0121
Added process updates regarding PSA reviews and approvals of these types of projects. Consolidated language in SOP# 08 and SOP #18 into this SOP in order to remove redundancies in SOPs. Retired SOP# 08 and SOP# 18 to remove redundancies.
Q005 /18
Appendix A – Initial Integrify® automated email to Research Team with completed Workbook:
Good afternoon _________________,
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 suf ficiently 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. IfIdonothearbackfromyouwithin90days,Iwillcloseyourfileandyouwill have to resubmit f or Children’s PSA. Please let me know if you have questions/concerns.
With regards,
SOP No: 03b – Date: 12/20/18 (Draft); 02/17/21; 02/25/21; 6/3/21; 6/9/21; 8/25/21