Page 69 - 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
RA Study Team
Modifications
RA Quality
Executed
UTSW Contracts
RA Leadership/Finance
Forwards All New Study Requests to Proper UTSW Contracts Office
Collaborate to complete a SOA
Draft SOA
Collaborate to complete a SOA
Complete the CTA & CTCA
Route for signatures Execute SOA and Upload into Velos
Review & Approve SOA for signatures Execute CTA for internally funded studies
Review CTCA and SOA
Submit SOA for Pricing
Facilitate the SOA process until SOA is
Track approval and expiration
Notify of
The establishment, maintenance and close-out of SOWs are managed interdependently across the study team, appointed research administration (RA) quality specialist (QS), RA leadership, research finance (RF) manager, and a representative of the legal and contracts departments when applicable. In some cases, a coverage analysis and CTA negotiation are supported by an external partner, PFS Clinical. All SOWs will be approved by the RA Director(s) and RF teams. The RA Vice President is the only authorizing signatory. Please, see Table 2 for an outline of the responsibilities related to SOW by phase of study and across positions.
Table 2. Responsibilities Related to SOW Across Position
Study Team & Team Leads
Order Entry
EPIC RBR Time Tracking
Get RF Clearance to
Quality Specialist
Children’s Health Legal & Contracts
Leadership & Finance
CTS/Director Approval
Feasibility Analysis Collaborate in SOW Draft Track Expiration of SOW
Submit Modifications Financial Management:
Review CTS/ Feasibility/ CTCA Complete SOW Draft Obtain Director Approval RF Pricing/Approval
Route for Signatures (post- CTA) Process Modifications Document
SOW Close-Out
Draft CTA with Sponsor Incorporate CTCA RA Leadership Review
Gain Sponsor Approval Route for Signatures Process Modifications
Review Mission Merit
Financial Feasibility Review/Approve SOW Execute SOW - Vice
President
Execute CTA- Vice
President Maintain CTA Compliance
Process Modifications Process Research
5. RESPONSIBILITIES
Close-Out
5.1 Study Funding Agreements, Implementation (see attached)
Update CTA Close- Invoices
Out
Track AR Balance Research Account
Report Mission Outcomes
Determination of Study Funding Agreement will require an inventory of the study and the conditions surrounding the study to determine whether the study requires: 1) SOA, 2) SOW, or 3) letter of exemption.
Engaging Key Personnel awareness of when and who to engage in the process of securing a study funding agreement must be made and followed to promote efficiency of work flow.
Navigating the Process is defined temporally. The correct process must be adhered to in order to avoid unnecessary delay or errors that will ensue downstream complications. Special attention must be paid to move in compliance to the NO SOA/NO Work Rule (see Attached).
5.2 SOA Initiation & Execution (See Attached for Department of Pediatrics and non-Pediatrics)
Initiation of SOA: Studies with external funding must initiate a SOA according to the Schedule of Priority. The clinical research coordinator (CRC) or associate (CRA) initiates the SOA by making a request to UTSW contracts department. Requests for SOAs should be made through the pedsresearch@utsouthwestern.edu email for studies that have a principal investigator (PI) employed through the pediatric department. Requests for SOAs should be made
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