Page 196 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q005
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
Review of your project is complete and has been forwarded to Dr. Jeff Khan for performance site approval (see email below).
Once approved, Velos will be updated with the date of approval, typically within 1-2 business days, with the performance site status change shown as “Performance Site – Approved”. Study activities cannot commence until Children’s Approval has been reflected in Velos.
(For studies that will submit a data request, add: Please submit your data request per the Quick Reference Guide attached).
As a reminder, it is the study team’s responsibility to ensure procedures are coordinated/scheduled with the clinical area in advance.
[For studies with billable charges:] Following receipt of site approval, please update your Velos status tab to “Study - Active/Enrolling” before the first subject is enrolled. RA finance team analyst, ___________________, will activate your study in Children’s EPIC.
Citation Policy: Any researcher who receives funding or research support of any kind from Children’s, including the use of data, must acknowledge the support in all publications, newsletters, presentations, and posters by stating "Research reported in this publication was supported by Children’s HealthSM. The content is solely the responsibility of the authors and does not necessarily represent the official views of Children’s HealthSM.” All publications must be registered with PubMed Central (PMC) immediately upon acceptance for publication, if accepted into a journal that automatically deposits in PMC.
With regards, Assigned QS Review
Appendix C(2) – Performance Site Approval Notification Template to Study Team (Projects without a SOA) – Path Forward (No SOA Required) (
To: PI and Study Team
Cc: QS Reviewers, Research Finance, Sharon Posey
Dear Study Team,
Review of your project is complete and has been forwarded to Dr. Jeff Khan for performance site approval (see email below).
to Medical Director email [Appendix B], update the email below, and attach the No SOA
Required word document)
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
Forward the PSA Request