Page 253 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q015 SOP Title: Quality Specialist Performance
Site Review Study File Management Plan
Within each study e-folder, the following sub-folders should be created (if needed based on study type):
Not all studies require the above sub-folders (i.e. expedited/exempt projects may not require an SOA, Standard Review, Facility Use Agreement sub-folders). Depending on the study, assigned QS may delete sub-folders that are not appropriate to maintain for the type of study that is under review. A template folder is located in the following directory: X:\Quality Specialists\PSAs\PI_12345_STU-20XX-XXXX
− Adult Patient Recruitment – Only for studies where an adult patient population (≥19) is identified in the protocol eligibility criteria
− External IRB – For Cooperative Research project with a single IRB of record. All approvals including IAA documents should be filed here.
− CTCA – This folder should contain the approved CTCA at the time of PSA request receipt;
− UTSW HRPPO eIRB Approved Consent HIPAA Form – This folder should contain the eIRB approved IC/HIPAA form(s) at the time of PSA request receipt;
− UTSW HRPPO eIRB Forms - This folder should contain the eIRB Lite forms (A, B, C, D, etc.) at the time of PSA request receipt;
− E-Mail Communication – Pertinent e-mails between assigned QS team member and members of the study team. Suggested e-mails to consider include the initial PSR acknowledgement by the QS team member and all study status notices including the e-mail approval notice at the time PSA is granted;
− Facility Use Agreement – If applicable, this folder should contain the initial FUA request e-mail and the finalized FUA document at the time of PSA request receipt;
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