Page 243 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q013
SOP Title: Guideline for Revising SOAs Impacted by Modifications
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the steps that need to be followed for revising service order agreements (SOA) impacted by major modifications to the study.
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. SCOPE
This SOP applies to all departments conducting research at Children’s Health.
Documentation consists of review of the modified protocol and supporting document in order to identify the new services. At UTSW, there is a requirement that major modifications to the protocol requires the resubmission of the study for clinical trial coverage analysis (CTCA) re-determination. The protocol along with the updated consent form and the revised CTCA are utilized in modifying the SOA.
4. RESPONSIBILITIES Children’s Quality Specialist
To work with the research team submitting the modification to the IRB and apprise them that the SOA will also need to be reviewed and modified.
Research Administration Financial Services Support
A modification to the SOA will be required for documentation of new research services provided as a result of the change. Until further updates, the process is as follows:
1. For all studies with confirmation of modified research billable services, an SOA modification will required.
2. Members of the RA finance team will need to be made aware of the new services being performed while the modified SOA is under review. The purpose of this notification is to guard against patients and/or their insurance payers being billed in error for research services.
Projects that require assistance from ancillary departments (e.g. IDS pharmacy, Laboratory/Pathology, Radiology, Infusion Department, etc.) will need members of supporting department to review the modified protocol and identify new services. Some departments will provide an updated support letter including identification of new services.
SOP No. 12, 12-20-2018