Page 216 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
1. PURPOSE
Research Administration SOP No: Q009
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
The purpose of this Standard Operating Procedure (SOP) is to describe the steps for review and approval of expedited and exempt projects.
2. INTRODUCTION
CHRA requires that a Performance Site Approval (PSA) application is evaluated 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 and documents, verification whether a DUA or MTA is required, approval from ancillary departments supporting the research project (e.g. Lab Support Letter), Standard Review assessment (if applicable), AA data requests (if applicable), funding support (if applicable), and execution of any agreements needed (such as a SOA or SOW for studies with billable services or a FUA for industry-sponsored research projects).
4. RESPONSIBILITIES
4.1 Children’s Quality Specialist
The Quality Specialist will work with the research team submitting the PSR application, determine approval requirements have been met by the reviewing IRB and Children’s Health, and the study will be conducted in compliance with federal, state and local regulations and institutional policies governing human subjects’ research. For lapsed studies that do not have documentation of CHRA PSA, please reference SOP No. 2 – Lapsed IRB Study Process and review the template letter in Appendix A.
Research Administration Financial Services Support
For studies with research billable services (e.g., Investigational Drug Services, Path/Lab, Imaging, etc.), 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 may be other service agreements needed to document funding prior to PSA being issued. These may include: Service Order Worksheet (SOW), Labor SOA (LSOA), or others.
4.2 Projects which require assistance from ancillary departments (e.g. Investigational Drug Services, Pathology/Laboratory services, Radiology, Infusion Department, etc.) will need members of supporting department(s) to review the study protocol/supporting documentation and provide approval to assist with providing services to the researcher
SOP No: 03b – Date: 12/20/18 (Draft); 02/17/21; 02/25/21; 6/3/21; 6/9/21; 8/25/21; 6/03/22