Page 216 - 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
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to document a uniform manner of study file management, organization, and long term storage on a secure network for ease of access by members of Research Administration (RA) Children’s Health Systemof Texas.
2. INTRODUCTION
In line with our institution’s strategic priority of Quality, the current guidance provides guidance how to responsibly and effectively manage the study documents and matters of business in a designated, secure folder on the shared drive.
3. SCOPE
This SOP applies to all performance site review application requests which lists CMC as a performance site.
4. RESPONSIBILITIES
4.1 Quality Specialists
Members of the QS team will be responsible to follow new stand ards in documentation and long term storage of e-files/folder for future reference and utilization by members of the RA leadership.
5. 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 support documentsinanorderedfashionbasedonPSRreviewrequestdate.QSteammember creates electronic as well as hard copies files of the eIRB/Velos staffing plan, CTCA documentation, Protocol, SOA, summary review of the project, and all other supporting documents. These electronic files are saved in the following directory under the assigned QS team member: X:\Quality Specialists\PSAs\Pending PSAs
Research Finance (\\childrens.med\depts\RESEARCH\SHARE\CLINICAL RESEARCH) Quality Specialists – Performance Site Review Applications
Pending PSAs
Kita Cathey Jayni George Mike Molai
Version 1, 11-27-2018 Page 3 of 6