Page 70 - eBook Version 8 Book 1 of 2 JUL 2022

5.3
Research Administration SOP No: R-Reg-005 SOP Title: Securing Reimbursement for Your Study
Lance.Holmes@UTSouthwestern.edu emails for studies that have a PI employed through a non- pediatric department. Requests for SOAs should be made through the Monica.Villagomez@UTSouthwestern.edu email for urology studies. RA requires its research coordinators and associates to adhere to the No SOA/ No Work Rule (see Appendix 1 & 2).
Execution of SOA: Once the study is assigned to a UTSW contracts person they will draft a SOA incorporating the invoiceable staff time for each study visit computed in the CRC timesheet. It is vital that all invoiceable items are accounted for and the terms of the agreement are defined on the SOA. Upon completion of the SOA draft, the SOA will be reviewed by the study team and RA quality specialists overseeing the SOA process. Once all discrepancies are resolved, the SOA is routed for PI signature. The RA vice president is the signatory for Children’s Health. Following approval, the purchase order is provided to the sponsor so that the contract can be executed and SOA uploaded into Velos. When modifications to the SOA are necessary, the same process is followed.
SOW Initiation & Execution (see Attached)
Initiation of SOW: IntheeventthatarequestforSOWdoesnotoriginateatthroughRAleadership,the CRC or CRA can initiates the SOW by making a request to RA director, and RA finance. Requests for SOWs should be made through the Research.Finance@Childrens.com email. RA requires its research coordinators and associates to adhere to the No SOA/ No Work Rule (see Attached).
Execution of SOW: RA quality team receives the SOW and collaborates with the study coordination team to draft a SOW complete with the invoiceable staff time for each study visit computed from the CTS timesheet as it applies. It is vital that all invoiceable items are accounted for and the terms of the agreement are defined on the SOW. Upon completion of the SOW draft, it will be reviewed by RA finance and the RA director. Once all discrepancies are resolved, the SOW is routed for PI signature, and the RA vice president is the signatory for Children’s Health. Following approval, the fully executed SOW is kept in the study file and research finance folder on the shared drive and tracked by the study coordination team and team leads. When modifications to the SOW are necessary, the same process is followed.
SPECIFIC PROCEDURE
Study Funding Agreements, Implementation (see Attached)
Implementation: Implementation of the Study funding Agreement should follow the No SOA/No Work Rule (Appendix 2). Please, see Appendix 1 for further guidance on implementing this process.
SOA Initiation & Execution (See Attached for Department of Pediatrics and non-Pediatrics)
SOA Initiation: Studies must complete a SOA determination (See Attached).
STANDARD OPERATING PROCEDURE
6. 6.1
6.2
6.2.1
6.2.1.1 To initiate a request, the CRC/A should send an email the appropriate UTSW contracts mailbox.
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For pediatric studies: pedsresearch@utsouthwestern.edu
For non-pediatric studies Lance.Holmes@UTSouthwestern.edu
For Urology studies: Monica.Villagomez@UTSouthwestern.edu
6.2.2 SOA Process: The SOA is executed by the assigned UTSW contracts person, and supported by the CRC/A, the RA quality team, RA finance, and RA leadership.
6.2.2.1 The CRC/A will work with their team lead to complete a CTS timesheet. They will schedule a Page 5 of 11