Page 251 - 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
ACRONYMS
CMC – Children’s Medical Center
CTCA – Clinical Trial Coverage Analysis DOA – Delegation of Authority
eIRB – electronic Institutional Review Board PI – Principal Investigator
PSA – Performance Site Approval
PSR – Performance Site Review
QS – Quality Specialist
RA – Research Administration
SOA – Service Order Agreement
SOP – Standard Operating Procedure Velos – Research Management Tool
1. INTRODUCTION & PURPOSE
The purpose of this standard operating procedure is to document a uniform process for study file management, organization, and long-term storage on Children’s secure network for ease of access by members of RA. Moreover, with the environmental cost and financial burden to the organization, the process of PSA review transitioned to paperless format, effective March 01, 2020. All documents, notes, request, pertinent correspondence are now saved electronically in the shared drive as described below.
2. SCOPE
This SOP applies to all performance site review application requests which lists CMC as a performance site.
3. RESPONSIBILITIES
3.1 Quality Specialists
Members of the QS team will be responsible to follow new standards in documentation and long term storage of e-files/folder for future reference and utilization by members of the RA leadership.
4. SPECIFIC PROCEDURE
Following initial receipt of performance site review request in Velos, assigned member of the QS team will review the eIRB application, study protocol, and all supporting documents in a first come, first served fashion based on PSR review request date. QS team member will create electronic files of the eIRB/Velos staffing plan, CTCA documentation, Protocol, SOA, summary review of the project (for full board projects only), eIRB approved consent/HIPAA forms, and all other supporting documents (based on study type). These electronic files are saved in the following directory under the assigned QS team member: X:\Quality Specialists\PSAs\Pending PSAs
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