Page 123 - eBook Version 8 Book 1 of 2 JUL 2022

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PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the procedures to be followed when requesting performance site approval (PSA).
INTRODUCTION
As part of the continued effort to ensure the quality and safety of research at Children’s Health System of Texas (CHST), Research Administration (RA) conducts a PSA in order to ensure that the study and study team are compliant with the appropriate regulations and policies prior to enrolling any subjects on the study. All studies that conduct research with CHST as a site must obtain a PSA to perform the study.
SCOPE
This SOP applies to all clinical research staff on the study team that conduct clinical research at Children’s Health System of Texas (CHST). The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team will ensure adherence to this SOP. In some case, a UTSW regulatory team lead, Amanda Lee, Amanda.lee@UTSouthwestern.edu may complete the PSA. The CRC/A should confirm with their team lead about who will assume the responsibility of the SEV. The team lead will ensure the appropriate institution is credited the start-up time on the transition sheet of the CTS (see SOP CTS and Transition Time Sheet). The remainder of this SOP outlines the steps to be taken in the event that a CHST team member will complete the PSA.
RESPONSIBILITIES Study Team
The study team will work cooperatively with assigned principal investigators (PI), co- investigators, or sub-investigators, as well as with CHST (RA) to ensure that all PSA requirements are met. The performance site review should be completed in observance of the No SOA/ No Work Rule (see SOPs Virtual Office Navigator, Overview of Study Start-Up) and current to the IRB submission (see SOP Study submissions for more guidance).
PROCESS
Step 1: Log into VELOS: https://velos.swmed.edu
▪ Type in your Username (lowercase) and Password
▪ Fields required by VELOS are marked with an (*); however, complete
every field that applies to your study. Step 2: Locate your Study
▪ Enter the VELOS study number or name in the Search a Study field to locate study.
▪ Click on the Study Summary clipboard associated with the study. Step 3: Complete the Performance Site Approval Form
Performance Site Approval Research Administration SOP No: R-Reg-007 SOP Title: Performance Site Approvals
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