Page 218 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q015 SOP Title: Quality Specialist Performance
Site Review Study File Management Plan
− CTCA – This folder should contain the approved CTCA at the time of PSA;
− eIRB Approved Consent HIPAA Form – This folder should contain the eIRB
approved IC/HIPAA form(s) at the time of PSA;
− eIRB Forms - This folder should contain the eIRB Lite forms (A, B, C, D, etc.) at the time of PSA;
− 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;
− Lab & Pathology Support Letter – If applicable, this folder should contain the Lab/Pathology Support e-mail and Lab/Pathology Support letter at the time of PSA;
− Protocol_IB_MOP_LabManual_Pharmacy Manual – This folder should contain a copy of the protocol, IB, MOP, Lab/Pharmacy manual (if applicable) at the time of PSA;
− SOA – This folder should contain pertinent SOA request e-mails and finalized SOA at the time of PSA;
− Sponsor Forms_CRFs_1572_IND_Statement of Investigator – This folder should contain copies of sponsor forms including case report forms (data collection form), FDA 1572 (if applicable), IND/IDE letters (if applicable), any pertinent sponsor forms provided by members of the research team at the time of PSA;
− Staffing Plan – This folder should contain copies of the staffing plan and DOA at the time of PSA;
− Standard Review – If applicable, this folder should contain a copy of the initial SR e-mail request, pertinent milestone e-mails, and final e-mail from SR once device/technology has been approved;
− Synopsis – A copy of the QS summary of the study including questions, concerns, and requests will need to be saved for reference.
− PSA Checklist – At the time PSA is granted, assigned QS team member will scan a copy of the finalized and completed PSA checklist into the main study f older
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
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