Page 200 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q006
SOP Title: Research Administration Quality and Financial Reviews
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures to be followed for the Research Administration Quality and Financial Reviews.
2. INTRODUCTION
Research Administration will perform Quality and Financial Reviews of approved research studies being conducted at Children’s Health.
For cross functional processes, it is good practice and common expectations within the Children’s Health and from industry best practice that procedures must be in place to ensure the accountability, traceability, and consistency of studies conducted at Children’s Health.
3. SCOPE
This SOP applies to Research Administration Quality Specialists (QA) and Research Administration Financial Specialists.
QA documentation consists of identification of studies that may benefit from Quality Reviews
4. RESPONSIBILITIES
4.1 Research Quality Specialist
• Review the list of Performance Site Approvals (PSAs) from databases maintained by Research Administration
• Identify studies eligible for Quality Reviews determined by institutional priorities
4.2 Research Financial Specialist
• Review participants’ research billing account who are identified by Quality Specialists during quality review
• Confirm billable research charges are captured and invoiced accurately
5. SPECIFIC PROCEDURE
5.1
• Since September 2021, Children’s Research Administration has partnered with UTSW HRPP for Quality Review of clinical studies listing Children’s as a performance site.
• Seven (7) days prior to a Quality Review, Quality Specialist will work with UTSW HRPP counterpart to prepare and send a Notice of Quality Review on UTSW letterhead to the PI and the Research Coordinator, confirming a date for the Quality Review; Financial Specialist will be notified.
SOP No. 4 Revised, Date: 04/12/18, 07/24/18; 08/17/21, 05/31/22