Page 318 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-200
SOP Title: Study Closure, Secured Share Drive, Storeroom & Cubicle Guidance
1. PURPOSE
The purpose of this standard operating procedures (SOP) is to outline the procedures and guidance for closing studies at Children’s Health System of Texas (CHST).
2. INTRODUCTION
In observance of the regulations and policies around closing studies and record retention, Research Administration (RA) has developed a study close-out process complete with guidance on long term storage of the study documents. In line with our core values of commitment to excellence, our procedures on this initiative and its related matters, such as electronic and physical record storage, considers supportive guidance on our designated storage room and cubicle spaces.
3. SCOPE
This SOP applies to all staff in RA responsible for compliant closing of research studies.
4. RESPONSIBILITIES
Coordinators & Associates (CRC/A)
Team Leads (TL)
Administrators
Senior Director
Obtain PI, Sponsor & RA Approval to Close- Out Study
Provide Close-Out Checklist & communicate pending closure- to stakeholders
Complete Study Close- Out Checklist
Verify Close-Out Checklist
Research Finance: confirm all invoices have been paid
Complete End of Summary Worksheet
Confirm End of Summary Worksheet
Quality Specialists: Close- out Advanced Analytics, and study status in study inventory
Work with PI and TL to prepare the Files for Long Term Storage
Prepare Study files for Long Term Storage
Advise to the necessary file preparation and, storage and document destruction
Return ship, and Retire all equipment with the Ultimus form and document hand-off. Dispose all study materials
Verify all study supplies and equipment have been retired and retired and update inventory
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