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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q015 SOP Title: Quality Specialist Performance
Site Review Study File Management Plan
Following completion of review and confirmation to route for final approval, the study folder will be moved from the “Pending PSAs” location on the network drive to the “Approved PSAs” location on the network drive under the assigned QS team member: X:\Quality Specialists\PSAs\Approved PSAs
Research Finance (\\childrens.med\depts\RESEARCH\SHARE\CLINICAL RESEARCH) Quality Specialists – Performance Site Review Applications
Approved PSAs
In addition, previously approved projects that were scanned are also located in this directory. They are listed as “Approved PSA – Previously Scanned”
5. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q015
08/01/2022
Updated section to include language that QS reviews transitioned to paperless effective 03-01-2020. Cleaned up language.
Q015
Version 1, 11-27-2018, 02-07-2019; 02-21-2020; 06-03-22 Page 6 of 6
