Page 198 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
& Professional Services Operations Date: 3/24/2021
Re: IRB: Velos:
Title:
Research Administration SOP No: Q005
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
Dear Principal Investigator and Study Team Members,
Based upon a review of the above referenced protocol, Children’s Health Research Administration has determined that there are no Children’s billable charges related the above referenced study, and no Service Order Agreement (SOA) or worksheet (SOW) is required.
Please print this document and place it in your regulatory binder for documentation. If a modification is made to the protocol and/or study design that might result in billable charges, a re-evaluation of the protocol is required, and this determination may change.
If you have any questions related to this determination letter, regulations governing human subjects’ research, Children’s Medical Center’s research policies and procedures, or IRB compliance requirements, please contact us at: Research_Department@Childrens.com.
Sincerely,
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