Page 183 - 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
o Workbook Documentation – For projects where patients ≥ 19 years of age will be recruited, assigned QS specialist will document requirement for completion of Adult Patient Recruitment form and the Children’s leadership committee decision regarding inclusion of adult patients.
o Workbook Documentation – For projects that utilize technologies and medical devices that interact with Children’s network, assigned QS reviewer will assess the device/technology and will provide guidance for Standard Review (SR) Assessment. A ServiceNow SR request will be required prior to PSA.
o Workbook Documentation – For projects that require Facility Use Agreement, assigned QS specialist will documentation date of initiation and execution of the agreement.
o Workbook Documentation - For projects will research billable patient charges and research services, documentation that an agreement will be needed is noted in the Workbook.
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q004
08/01/2022
• Removal of Jayni George
• Removal of Victoria Brown
• Addition of reference to Integrify System
• Removal of Process Map
Q004
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