Page 71 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Research Administration SOP No: R-Reg-005 SOP Title: Securing Reimbursement for Your Study
meeting with the RA director to review and modify. Upon director’s approval, the CTS will be
sent to appropriate UTSW contracts representative by the director only.
6.2.2.2 Upon receipt of the CTCA and SOA request sent from the UTSW contracts representative,
the appointed Quality Specialist, Jayni George Jayni.George@Chidlrens.com w i l l complete a draft of the SOA.
6.2.2.3 The RA appointed Quality Specialist, Jayni George, will review and resolve all discrepancies collaboratively with the CRC/A quality specialists and UTSW contracts point person. A review will be completed with the RA Senior Director and routed to research finance for pricing upon approval.
6.2.2.4 The RA Finance Manager and RA leadership will review the SOA and provide approval of the SOA to routed for signatures by the respective UTSW Contracts representative.
6.2.2.5 The UTSW contracts personnel will route the SOA for signatures first to the PI and finally the RA Vice President will execute the SOA.
6.2.2.6 The UTSW contracts personnel will provide the sponsor with a purchase order number and finalize the study contract.
6.2.2.7The fully executed SOA will be uploaded into Velos and tracked by the study coordination team and team leads using the Transition Plan Tracker.
6.2.2.8 For modifications to the SOA, please follow steps 5.2.1 through 5.2.2.7.
6.3 SOW Initiation & Execution
6.3.1 SOW Initiation: Studies with internal funding must initiate a SOW (see attached)
6.3.1.1 To initiate a request, the CRC/A should send an email to RA finance at
Research.Finance@Childrens.com.
6.3.2 SOW Process: The SOW process is carried the assigned RA quality specialist (Jayni.George@Childrens.com ), RA finance, and executed by RA leadership.
6.3.2.1 The CRC/A will inform their team lead of any new studies for which their PIs intend to use internal funds to support the costs incurred for doing research at CHST.
6.3.2.2 The CRC/A will work with their team lead to complete and submit to their directors for approval to be provided the assigned RA quality specialist, Jayni George, with an approved CTS.
6.3.2.3 Upon completion of a SOW draft, the assigned Quality specialist, Jayni George, will reach out to the CRC/A and team lead to review and resolve all SOW discrepancies.
6.3.2.4 RA leadership will review and approve and then route the SOW to the PI a n d t h e vice Presiden,for theirsignatures.
6.3.2.5 The fully executed SOW will be is kept in the study file and research finance folder on the shared drive and tracked by the study coordination team and team leads.
6.3.2.6 For modifications to the SOW, please follow steps 6.3.2.1 through 6.3.2.5. Page 6 of 11