Page 68 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
1. PURPOSE
Research Administration SOP No: R-Reg-005 SOP Title: Securing Reimbursement for Your Study
The purpose of this standard operating procedure (SOP) is to describe the steps to be followed for the development of a service order agreement (SOA) or service order worksheet (SOW). A SOA or SOW must be in place to for all research related charges incurred at Children’s Health.
2. INTRODUCTION
Alongside our institution’s strategic priority of growth, our institution must be reimbursed for the services it provides. Therefore, it is required that all services provided by Research Administration (RA) are accounted for in a SOA, which is a financial contract between our department and the University of Texas Southwestern (UTSW) Medical Center for research related charges. A SOW accounts for all services conducted internally within Children’s Health. Otherwise, reimbursement can be guaranteed with a grant management order (GMO) or contract management order (CMO). The current objective is crucial to our department’s sustainability, and is a fundamental factor in promoting the growth of research.
All research conducted at Children’s Health supported by internal funds, such as a grant awarded by the Children’s Clinical Research Advisory Committee (CCRAC), mission grant, or service package grant (SPG); or by funds otherwise officed in-house through the establishment of a clinical trial agreement (CTA) between an external sponsor and Children’s Health, will require a SOW to define the internal flow of funds. A SOW is an internal worksheet outlining the resources and relative charges required for a given study by use of internal funds, or funds otherwise officed at Children’s Health.
The current SOP defines the method for securing funding agreements as it relates to the study conditions in the form of a SOA, SOW, or letter of exemption as applicable.
3. SCOPE
The current SOP pertains to all stakeholders adhering to the mandates outlined in policies CP 7.12 and CP 7.37 in the securing of reimbursement for charges incurred by doing research at CHST.
4. RESPONSIBILITIES
This SOP applies to Children’s Health RA study coordination team, quality specialists, finance, leadership, and the University of Texas Southwestern (UTSW) contracts department as outlined in Table 1. The study team is responsible for steering the process and initiating the initial request and modifications for a funding agreement, as well as ensuring clarification for study procedures as they relate to the study protocol and supporting documents. RA quality specialists will work collaboratively with the study team and UTSW sponsored programs administration (SPA), or respective contracts department, to complete a SOA. UTSW will work with the RA Finance Management and RA Senior Director to execute a SOA. SOWs will be reviewed by RA quality and finance teams and executed by the RA Director. The Vice President serves as the authorizing signatory.
Table 1. Responsibilities Related to SOA Across Position Page 3 of 11