Page 236 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Quality Specialists SOP No: Q012
SOP Title: Service Line Business Case Development
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the process and procedures for creating and establishing a service order agreement (SOA).
2. INTRODUCTION
An SOA is a document that captures research billable services and associated costs that are assigned to the study payer. These billable charges are not the responsibility of the patient and/or their payer. During the course of the study, there are times where major modifications to the protocol may require the addition of new services or visits to the study. In these cases, the SOA will need to be modified in order to accurately capture these new billable services.
3. STUDY TEAM RESPONSIBILITIES
Study team Responsibilities – For SOA initiation at UTSW
1. For studies where the PI’s primary faculty appointment is in the Department of Pediatrics, after receiving the approved clinical trial coverage analysis (CTCA), a member of the study team (Principal Investigator/Primary Research Coordinator/Primary Administration Coordinator) will initiate a SOA request via e-mail to PedsResearch@UTSouthwestern.edu.
2. For studies where the PI’s primary faculty appointment is in a non-Pediatrics Department, after receiving the approved clinical trial coverage analysis (CTCA), a member of the study team (Principal Investigator/Primary Research Coordinator/Primary Administration Coordinator) will initiate a SOA request through The Office of Sponsored Program Administration via e-mail to Jonathan.Leer@UTSouthwestern.edu and Amanda.Mier@UTSouthwestern.edu.
3. UTSW will create and save the initial draft SOA and will also upload a copy in Velos under the “Documents” tab.
4. Once a draft SOA is agreed upon between UTSW and members of the study team, the study team will send an initial review request to Children’s Health Research Administration via email to Research.Finance@childrens.com .
Children’s Health Research Administration (RA) Financial Analyst Responsibilities
5. Upon receipt of the SOA draft (see bullet #4 above), the Financial Analyst (or designee) will:
a. Send an acknowledgment email to the requester,
b. Log the request in REDCap,
c. Send a “DRAFT SOA REVIEW REQUEST” email to the SOA Quality Specialists,
SOA Quality Specialist (QS) Responsibilities
6. Upon receipt of the SOA from Research Finance the SOA QS will add the SOA to his/her queue for review. During the review he/she will:
a. Review the CTCA, Protocol, ICF, and Team Lead approved RC Time Sheet to ensure all CMC billable charges are captured on the SOA.
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