Page 482 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: F011
SOP Title: Research Billing to Sponsors
1. PURPOSE & INTRODUCTION
The purpose of this standard operating procedure (SOP) is to describe the process for research billing Clinical Trials when Children’s Health holds the contract.
2. SCOPE
Research Finance will receive automatic payments or is responsible for submitting an invoice for conditional procedures to the sponsor as outlined by the Clinical Trial Agreement (CTA) payment schedule for research related encounters per the study protocol.
3. RESPONSIBILITIES & SPECIFIC PROCEDURE
This SOP applies to Children’s Health Finance group in Research Administration.
3.1. Obtain a copy of the fully executed Clinical Trial Agreement (CTA) from the Director of Research Administration. Review the “Payment Schedule” section which lists the payment amounts expected for all research related activity as agreed to in the study budget. The payment schedule will include a section listing the reimbursement amounts for the study visits and another section listing the reimbursement amounts for conditional procedures such as start-up fees, pharmacy maintenance recurring fees, regulatory fees, and/or other exclusive fees.
3.2. Study visits are automatically paid by the sponsor after the research coordinator submits a study visit Case Report Form (CRF) in the Electronic Data Capture (EDC) portal as subjects are enrolled and progress throughout the study. Sponsors withhold 10% of the payment amount for each visit until the end of the study.
3.3. Conditional procedures are paid by the sponsor after the financial analyst submits an invoice for the items. Include an additional charge item in the invoice for overhead costs. Sponsors will not withhold 10% of the payment amount on conditional procedures.
3.4. The Financial Analyst will determine which service to expect automatic payment on or will invoice the sponsor for conditional procedures after the monthly research billing report provided by the Research Finance Manager is available for review. The research billing report captures all research activity reported by the coordinator in Epic for the previous month. Epic is the hospital’s electronic health record system that allows users access to patient data.
3.5. It is the responsibility of the coordinator to ensure that study procedure orders or HCHG codes are appropriately entered in Epic, however the Team Leads or Research Finance are available for assistance. If a charge entry error is found by the analyst when the daily Epic Research Billing Review is being performed, it will be escalated to the coordinator to correct the charge.