Page 159 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q005
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
Appendix D – No SOA Required word document (for studies incurring no billable charges)
To: PI
From: VictoriaBrown,Ph.D.
Director, Children’s Research Administration
Date: 3/24/2021
Re: IRB: Velos:
Title:
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,
Victoria Brown, Ph.D.
Director, Research Administration
Children’s Health Children’s Medical Center at Dallas
SOP No: 03b – Date: 12/20/18 (Draft); 02/17/21; 02/25/21; 6/3/21; 6/9/21; 8/25/21