Page 237 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Quality Specialists SOP No: Q012
SOP Title: Service Line Business Case Development
b. Ensure that approval emails have been received from all ancillary services that will be used for the study (IDS, Pathology)
c. The SOA check sheet will be used as guidance for the review process. This check sheet should be attached to the SOA review folder created by the SOA QS
SOA QS and Senior Director of Research Administration (RA) Responsibilities
7. SOA QS will set-up weekly SOA review meetings with the Senior Director of RA to review the draft SOA, approved CTCA, study protocol, and supporting documents (e.g. Lab Manual; sponsor budget)
8. Prior to the weekly meeting the SOA QS will email the Senior director the documents for review
9. Approved CTCA, protocol, sponsor budget, and draft SOA will be reviewed for consistency in documentation of research billable services. Concerns (e.g. missing procedures, supplies, and any other billable charges) will be noted on the SOA (in Office Word Track Changes) and shared with members of the study team. All appropriate CPT codes will be filled in by the SOA QS and verified by the Senior Director.
10. SOA QS will work with members of the study team on any outstanding questions
11. Once completed, an “approved” draft SOA will be sent to the Senior Financial Analyst
responsible for SOA pricing with the email title: PIname_Velos#_e-IRBnumber: SOA READY FOR PRICING
SOA Quality Specialist, Finance Manager, and Administrative Coordinator Responsibilities
12. Following receipt of the reviewed draft SOA, Senior Financial Analyst will confirm/and or add prices. Where necessary they will also acquire prices and add them to the SOA. The Senior Financial Analyst is ultimately responsible for ensuring that all prices and CPT codes have been verified/double checked before giving final approval.
13. Once a final version of the draft SOA has been approved, the Senior Financial Analyst will send an email to the SOA QS with the priced SOA attached. The email should be titled: PIname_Velos#_e-IRBnumber: PRICING COMPLETE
14. If follow up information is needed, the Finance Team will send an email to SOA QS
15. SOA QS will send the priced SOA to the UTSW contact. The email should be titled
PIname_Velos#_e-IRBnumber: CMC PRICING COMPLETE
16. SOA QS will work with the assigned UTSW personnel and members of the PI’s study team to address all discrepancies.
17. Once a final SOA has been agreed upon by all parties, Ms. Jayni George will route a clean copy of the final approved SOA for DocuSign signatures to the study team via email titled: PIname_Velos#_e-IRBnumber: SOA_CMC APPROVED_READY TO ROUTE.
Page 3 of 6