Page 233 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q011
SOP Title: Facility Use Agreement - CMC as a Clinical Site
1. INTRODUCTION & PURPOSE
Research Administrations and Legal Affairs at Children’s HealthTM have determined that industry-sponsored clinical trials require the execution of a Facility Use Agreement (FUA) between the industry sponsor and Children’s HealthTM. The intent behind an FUA is to indemnify the facility and those listed on a given project who are employees of the facility against any legal risks since these provisions are not typically covered in the clinical trial agreement (CTA) negotiated between the study sponsor and University of Texas Southwestern Medical Center at Dallas. The Children’s Research Administration receives email notifications in the Research_Department Inbox indicating “IRB submissions listing Children’s as a Performance Site”. A cursory review will be performed to determine the type (prospective vs. retrospective) and funding mechanism (industry vs. all other funding sources).
2. SCOPE
This SOP applies to all study applications submitted to the IRB which lists CMC as a performance site.
3. RESPONSIBILITIES
3.1 Research Quality Specialist
Children’s Health Research Administration Quality Specialists will manage email notifications for study submissions listing Children’s as a performance site .
4. SPECIFIC PROCEDURE
Determination and Notification to PI/RC will follow two distinct paths:
A. ResearchernotifiestheSeniorDirectorofResearchAdministrationordesigneeat Children’s
• Before PSR request in Velos, researcher may elect to inform the Senior Director of Research Administration (or designee) at Children’s. In this instance, Senior Director of Research Administration or designee will acknowledge said request, log the study, and notify researcher of the steps required to initiate FUA process (please review steps outlined in the following section for more detail). Senior Director of Research Administration or designee will notify the Quality Specialist team regarding the study.
B. Assigned Quality Specialist team member will determine need for FUA following receipt of PSR request in Velos
• Assigned Quality Specialist (QS) will review the IRB application. A determination of project type (retrospective vs. prospective) and funding mechanism (industry vs. all other funding sources) will be performed.
• Senior Director of Research Administration or designee will log study in the FUA spreadsheet for further action.
• Assigned QS will send an e-mail to the PI/RC with the following request:
Based on a rendering from Legal Affairs at CMC, it has been decided that industry-sponsored clinical trials require the execution of a Facility Use Agreement (FUA). Please contact Deborah (Deb) Town, Senior Director of Research Administration or designee, via an introductory e-mail to your
Version 4, 10/12/16, 10/13/16, 10/27/16, 10/28/16, 05/31/22 Page 2 of 3