Page 368 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q024 SOP Title: Study Closeout Process
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the process for closing out studies at Children’s Health.
2. INTRODUCTION
Children’s Research Administration receives research-related email notifications from UTSW IRB in the Research Department mailbox titled ‘CMC – Notice of Study Closure.’ The Quality Specialists team owns the management of the mailbox.
3. RESPONSIBILITIES
Quality Specialists are tasked to move email types into assigned subfolders. The Quality Specialist will be responsible for advising the Finance Team that a Notice of Study Closeout has been received and for the Research Finance Team to process study closeout processes.
Owners: Quality Specialists
CMC – Notice of Study Closure - A member of the Quality Specialists team will review the Research mailbox for notices of study closures. A member of the Quality Specialists team will send an email to the Research Finance Team informing them that the notice of study closure has been received.
▪ Quality Specialist will confirm with the Research Financial team if there are any outstanding invoices to be sent and for close out of the SOA, once all invoices have been sent.
4. PROCESS MAP - (NEEDS REVISING)
Quality Specialist
Clinical Research Mailbox
Finance
Clinical Research
Quality Research Specialist
CMC-CR Approved email notifications are filed in Research_Department Mailbox sub-folder called “CMC-CR Approved E-Mails” for members of the Research Administration to review
CMC-CR Approved
SOP No. 20, Date: 2/27/19