Page 186 - 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
Appendix C – Performance Site Approval Notification Templates
Good morning/afternoon ____________,
Review of your project is complete and has been forwarded to Dr. Jeff Khan for performance site review/approval. 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.
After you verify the performance site approval is reflected in Velos, you must change the study status to “Active Enrolling” in Velos before your study can begin.
As a reminder, it is the study team’s responsibility to ensure procedures are coordinated/scheduled with the clinical area in advance. Remote/virtual visits should be utilized whenever possible.
* For studies with billable charges (other than Coordinator time) also include: 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 immediately upon acceptance for publication, if accepted into a journal that automatically deposits in PMC.
If you have any questions and/or concerns, please let me know. With regards,
Assigned QS Reviewer Cc: QS Team Members
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