Page 198 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q011
SOP Title: Facility Use Agreement - CMC as a Clinical Site
1. PURPOSE
The purpose of the current standard operating procedures (SOP) is to outline the process for facilitating the establishment of facility use agreements (FUA) for clinical trials conducted at Children’s Health System of T exas.
2. INTRODUCTION
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 betweenthe 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“IRBsubmissionslistingChildren’sasaPerformanceSite”. Acursoryreview will be performed to determine the type (prospective vs. retrospective) and funding mechanism (industry vs. all other funding sources).
3. SCOPE
This SOP applies to all study applications submitted to the IRB which lists CMC as a performance site.
4. RESPONSIBILITIES
4.1 Research Quality Specialist
Children’s Health Research Administration Quality Specialists will manage email notifications for study submissions listing Children’s as a performance site .
5. SPECIFIC PROCEDURE
Determination and Notification to PI/RC will follow two distinct paths:
A. ResearchernotifiestheDirectorofResearchAdministrationatChildren’s
• Before PSR request in Velos, researcher may elect to inform the Director of Research Administration at Children’s. In this instance, Director of Research Administration 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). Director of Research Administration will notify the Quality Specialist team regarding the study.
B. Quality Specialist team member will determine need for FUA following receipt of PSR request in Velos
• 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.
• For those projects that meet the need for an FUA (industry and prospective), a summary of the project including an FUA determination will be created and forwarded to Research Administration Director for acknowledgment.
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