Page 177 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-102 SOP Title: Finance & Regulatory Modifications
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline the guidance around submitting finance and regulatory modifications for all established studies conducted at Children’s Health System of Texas (CHST).
2. INTRODUCTION
As part of Commitment to Excellence all research studies must be maintained in accordance with the governing laws and policies. When an established study requires that changes are made, a protocol amendment is required. This SOP outlines the requirements for processing modifications in both the finance and regulatory domains of a study.
In more detail, once a study funding agreement is in place, any changes to the protocol or manual operating procedures could instantiate additional resources from CHST to carry-out the research study. A study coordinator, or associate should work with their team lead to initiate a modification to the study funding agreement (see R- Reg-105).
Additionally, once a protocol is approved by the Institutional Review Board (IRB), any subsequent changes require a modification which must be reviewed and approved by the IRB prior to implementation. To request approval of a proposed modification, complete and submit an eIRB Modification SmartForm (see eIRB Modification Tip Sheet).
3. SCOPE
This SOP applies to Research Coordinators, Associates, Sub-Investigator, Co- Investigator or Principal Investigator and any other staff members delegated the task of regulatory functions involved in the study.
4. RESPONSIBILITIES
4.1.1 Modifications to Research Finances
4.1.1.1 On the same day and receipt, send new study document to UTSW contracts and budgets , study team, and Research Finance Research.Finance@UTSouthwestern.edu, upload new document in Velos and submit a request for a coverage analysis modification, and your team lead.
• For pediatric studies: pedsresearch@utsouthwestern.edu
• For non-pediatric: studies see contacts section in the beginning of the
eBook
• For Urology studies: Monica.Villagomez@UTSouthwestern.edu
4.1.1.2 Work with your team lead to assess the protocol for changes in feasibility and logistics, as well as study staff time needed and complete a modification to the CTS, if warranted.
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