Page 229 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q010
SOP Title: PERFORMANCE SITE APPROVALS (PSA) PROCESS FOR EXTERNAL IRB APPROVED PROJECTS
approval prior to PSA being issued. Some departments will provide a support letter including identification of services that are required to support the study.
4.2a. Laboratory & Pathology Services – Studies that require assistance from Laboratory and Pathology Services will need to have a Research Laboratory Support Letter on file. Researchers will be directed to LabResearchAdmin@Childrens.com and the following needs to be provided: the PI’s name, Velos #, STU #, along with a copy of the Protocol.
4.2b. Investigational Drug Services – Clinical projects that utilize investigational drugs will need to have their protocol reviewed by IDS prior to initiation of the study. Researchers will be directed to IDSRx@Childrens.com and the following needs to be provided: the PI’s name, Velos #, STU #, along with a copy of the Protocol/pharmacy manual (if available)
4.2c. Standard Review – Clinical projects that utilize technologies provided by the study sponsor on loan and connect to Children’s network for the transmission of data to the sponsor or third party will need to have a Standard Review assessment. Other qualifying scenarios include the following: (1) any software which the sponsor directs the local researcher to download on a Children’s issued computer (desktop/laptop/portable device); (2) Any medical device (investigational or FDA approved) that is not being used in the Children’s environment.
4.2d. Other Departments – Clinical projects that provide services to support the study protocol will be contacted for review and approval.
4.3 For projects requiring a DUA or similar type agreements, QS will direct members of the research team to inquire with the Director of Research Administration at Children’s. A copy of the verification e-mail will need to be forwarded to the QS for their files. QS will remind the PI not to share data with external entity until the DUA has been finalized. For projects where the PI of record is an employee at Children’s Health, QS will direct the PI to inquire with CHRA by e-mailing Children’s Health Research Contracts at ResearchContracts@childrens.com for DUA or MTA determination.
5. SPECIFIC PROCEDURE
5.1 Scope PSA Review Process
1. Children’s Research Administration receives a notification from 1) Research Administration Director, 2) Research Administration Senior Director, or 3) Researcher directly requesting research activities on Children’s Health campus.
2. Quality Specialist(s) reviews notification and sends Researcher an IRB Approval Agreement template to be signed by the signatory for the external IRB and the signatory for Children’s Health.
3. Assigned QS team member will send a copy of a performance site review application template to the research team to complete. This document provides a
SOP No. 9, 12-20-2018