Page 185 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
1. PURPOSE
Research Administration SOP No: Q010
SOP Title: Performance Site Approval Process For External IRB-Approved Research Projects
The purpose of this Standard Operating Procedure (SOP) is to describe the steps to follow for performance site review and approval of research projects that are approved by external Institutional Review Boards (eIRB).
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 verifying that an IRB Approval Agreement (IAA) between Children’s Health and the external IRB of record is in place, verifying credentialing and CHRA required research training have been completed, reviewing externally facing studyformsanddocuments,verifyingwhetheraDUA/MTAisrequire,verifyingapproval from departments supporting the research project (e.g. Lab Support Letter , Standard Review assessment, Advanced Analytics, etc., if applicable), determination of any funding support (if applicable), and execution of any agreements needed (such as a SOAorSOWforstudieswithbillableservicesoraFUAforindustry-sponsoredresearch projects.
4. RESPONSIBILITIES
4.1 Children’s Quality Specialist
The Quality Specialist will 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 theprojecttotheChildren’sResearchAdministrationMedicalDirectorforfinalapproval acknowledgment.
Research Administration Financial Services Support
For studies with research billable services (e.g., Investigational Drug Services, Path/Lab,etc.), aserviceorderagreement(SOA)willberequiredfordocumentation 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, a SOA will need to be initiated and f ully 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.
SOP No. 9: 12-20-2018; 02-17-2021; 08-25-2021;