Page 78 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Research Administration SOP No: R006 SOP Title: Securing Reimbursement for Your Study
Building Your Study Budget SOA/W
All Research conducted at Children's Health System of Texas (CHST) must have one of the following in place prior to commencement of study related activities: 1) Service Order Agreement, 2) Service Order Worksheet Agreement, 3) a Labor Contract (G/CMO), or 4) a No SOA Determination Letter. The current document provides guidance on how to build a study budget. Drafting a SOA and SOW share a great deal of overlap. Any differences will be indicated. The presumption of this tool is that it will be used by research staff at CHST.
I. Service Order Agreement (SOA): A service order agreement is a contractually binding agreement between Children’s Medical Center Research Administration and the University of Texas Southwestern (UTSW) Medical Center for all research related charges incurred in the conduct of a research study at Children's Medical Center.
II. Service Order Worksheet (SOW): A scope of work agreement is a contractually binding agreement defining the flow of funds necessary in the process of carrying out a research study within Children’s Medical Center. More clearly, this agreement provides a financial structure to outline how internal funds will be processed internally.
Ø Purpose: To properly account for all research related charges. Ø Objectives: To capture all study procedures & invoiceable items
i. All procedures, materials, and time for study visits
ii. All other invoiceable items for contingent,
optional or emergency procedures; regulatory; pharmacy,
and administrative fees
Ø What is Required:
i. Knowledge of protocol and study manuals
ii. Knowledge of procedures & study population
iii. Site specific requirements: regulations & policy
iv. Principal Investigator’s (PI) expectations or directives
Research your study. Use the quadrants below to guide your analysis. The appointed QS will complete the SOW. You can use this guide to inform your review.
Quadrant I: Selection of Procedures
Quadrant II: Define the Procedures
Sponsor:
What procedures will be completed at the site? What procedures are standard of care?
What procedures are optional?
What procedures are contingent?
Principle Investigator (PI):
What procedures will be completed at the site?
Will the procedures also be conducted at an affiliated site? Subjects:
What procedures are optional?
Research the study population and procedures: Does patient population require certain accommodations (e.g., urine catheter for urine sample)?
How are the procedures labeled in EPIC?
How are the procedures bundled?
Are there differences between Children's Medical Center, sponsor or other relevant participating entities in how procedures are bundled?
What is the policy on how the procedures must be performed?
Are the procedures and requirements for procedures consistent with sponsor and PI’s plan?
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