Page 228 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
1. PURPOSE
Research Administration SOP No: Q010
SOP Title: PERFORMANCE SITE APPROVALS (PSA) PROCESS FOR EXTERNAL IRB APPROVED PROJECTS
The purpose of this Standard Operating Procedure (SOP) is to describe the steps that need to be followed for performance site review and approval of projects that are approved by external Institutional Review Boards (IRB).
2. INTRODUCTION
For external IRB approved studies, 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 that IRB Approval Agreement (IAA) between Children’s Health and the external IRB of record is in place, credentialing and CHRA required research training have been completed, review of externally facing study forms & documents, verification whether a DUA/MTA is required, approval from departments supporting the research project (e.g. Lab Support Letter, Standard Review assessment, if applicable), determination of funding support, execution of SOA (for studies with billable services), and execution of an FUA (for industry sponsored research projects).
4. RESPONSIBILITIES
4.1 Children’s Quality Specialist
To work with the research team submitting the initial request for Children’s site approval and verify that all check list items are in place prior to routing the project to the Children’s Research Administration Medical Director for final approval acknowledgment.
Research Administration Financial Services Support
A service order agreement (SOA) will be required for documentation of research services provided during the course of the project. Until further updates, the process is as follows:
1. For all studies with confirmation of research billable services, an SOA will need to be initiated and fully executed before PSA can be granted.
2. For studies that have sponsor budgets, members of the QS team will request a copy of the budget for review.
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
SOP No. 9, 12-20-2018