Page 180 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q004
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the steps that need to be followed for performance site review and approval.
2. INTRODUCTION
CHRA requires that a performance site application be reviewed and approved prior to initiation of research activities at Children’s Health.
For other cross-functional processes, it is good practice and common expectation at Children’s Health and from industry best practices that procedures must be in place to ensure accountability, traceability, and consistency in fulfilling regulatory and clinical requirements.
3. SCOPE
This SOP applies to all departments conducting research at Children’s Health.
Documentation consists of verification of credentialing and CHRA required research training, review of externally facing study forms & documents, corrective action plan correspondence, verification whether a DUA/MTA are required, approval from departments supporting the research project (e.g. Lab Support Letter), Standard Review assessment (if applicable), determination of funding support, execution of agreements such as an SOA for studies with research billable services an FUA for industry sponsored research projects).
4. RESPONSIBILITIES
4.1 Children’s Quality Specialist
To work with the research team submitting the PSR application, determine approval requirements have been met by the IRB and Children’s Health, and the study will be conducted according to federal, local, and institutional regulations governing human subjects research. For lapsed studies that do not have documentation of CHRA PSA, please reference SOP # 2 - Lapsed IRB Study Process and review the template letter in Appendix A
Research Administration Financial Services Support
For studies with research billable services, an SOA will be initiated at UTSW and forwarded to CHRA for verification and documentation of pricing before being finalized. Depending on the nature of the funding source, there are other service agreements that need to be documented prior to PSA being issued. They include: service order worksheet (SOW), Sponsored Service Order Worksheet (SSOW), labor SOA (LSOA).
4.2 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 study protocol, identify support services, and grant approval prior to PSA being issued. Some departments will provide a support letter including identification of services that are required to support the study.
SOP No. 3, Date: 4/13/16; revised 5/3/16; 7/5/16; 8/2/16; 09/18/2017; 03/19/2018; 03/19/2019; 07/17/2020; 11/02/2020; 02/25/2021; 06/03/2021, 05/31/2022