Page 164 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

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 response to each finding is expected within 6-weeks of the
final report submission to the PI/PRC/PAC.
• Quality Specialist will send draft Final Report to Leadership for review / advice /
discussion
• With Leadership revisions completed, Quality Specialist will finalize the report.
• Research Administration Management will assess level of findings and determine
whether additional follow-up review is warranted to ensure and maintain
compliance
• 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
• The Quality Specialist will send the Final Quality Review Report to the
PI/PRC/PAC for review and response, copying Leadership and the Financial
Specialist
• Upon receipt of PI’s responses, assigned QS and FS team members will review
each response and verify for completion
• PI’s responses will be forwarded to Leadership for review / comments.
• 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
SOP No. 4 Revised, Date: 04/12/18, 07/24/18; 08/17/21