Page 202 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q006
SOP Title: Research Administration Quality and Financial Reviews
DAY OF QUALITY REVIEW / Financial Specialist:
• For prospective studies, review the study in EPIC Research Billing Review (RBR) for participant(s) being reviewed and confirm all billable charges against the Service Order Agreement (SOA)
• Reconcile any charges not being captured by initiating a revision to the SOA or
• Confirm all charges are being captured and invoiced accurately
• Upon completion of the study and financial reviews above, QS and FS will discuss
any discrepancies observed
• Quality Specialist will prepare a draft Quality Review Report based on findings
noted during review. A draft copy of the findings letter will be shared with UTSW HRPP counterpart to finalize and submit to the research team on UTSW HRPP letterhead. A response to each finding is expected within 6-weeks of the final report submission to the PI/PRC/PAC.
• Depending on the nature of findings, the report will be provided to the Clinical Research Educator for follow-up training with members of the research team
• Upon receipt of PI’s responses, assigned QS and FS team members will review each response and verify for completion
• If responses are complete, Quality Specialist will complete the Quality Review Summary Tracking Report. For incomplete responses, assigned QS team member will work with members of the study team to ensure that all observations are addressed to the satisfaction of Children’s Research Administration.
• Quality Specialist will scan the final documents into the appropriate e-folder
• Financial Specialist will scan the final Report into the appropriate folder in
Research Administration’s network drive. Updates will also be documented on the SharePoint page.
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q006
08/01/2022
• Removal of Jayni George
• Removal of Victoria Brown
• Addition of Finance team member previously not included
• Updates to UTSW HRPP counterpart and joint review of clinical studies where Children’s is listed as a performance site.
• General clarification to QS preparation processes
Q006
SOP No. 4 Revised, Date: 04/12/18, 07/24/18; 08/17/21, 05/31/22