Page 195 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q010
SOP Title: Performance Site Approval Process For External IRB-Approved Research Projects
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.
Once approved, Velos will be updated with the date of approval, typically within 1 -2 business days,withtheperformancesitestatuschangeshownas“PerformanceSite–Approved”. Study activities cannot commence until Children’s Approval has been reflected in Velos.
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 include:] Following receipt of site approval, please update yourVelosstatustab to“Study-Active/Enrolling”beforethefirstsubjectisenrolled.RAfinance 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 F2 – Performance Site Approval Notification Template to Study Team (For Projects without a SOA) (Forward the PSA request to Medical Director email, update the email below, and attach the No SOA Required document)
To: PI and Study Team
Cc: QS Reviewers, Research Finance, Sharon Posey
SOP No. 9: 12-20-2018; 02-17-2021; 08-25-2021;