Page 80 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
Research Administration SOP No: R006 SOP Title: Securing Reimbursement for Your Study
RA Study Team
RA Quality
UTSW Contracts
RA Leadership/Finance
Forwards All New Study Requests to Proper UTSW Contracts Office
Track approval and expiration
Notify of Modifications
Collaborate to complete a SOA
Review CTCA and SOA Submit SOA for Pricing Facilitate the SOA process until SOA is Executed
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
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 Quality Specialist Children’s Health
& Team Leads Legal & Contracts
Leadership & Finance
CTS/Director Approval Feasibility Analysis Collaborate in SOW Draft Track Expiration of SOW Submit Modifications Financial Management:
Order Entry
EPIC RBR Time Tracking
Get RF Clearance to Close-Out
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 Update CTA Close-Out
Review Mission Merit
Financial Feasibility Review/Approve SOW
Execute SOW - Vice President
Execute CTA- Vice President Maintain CTA Compliance
Process Modifications Process Research Invoices Track AR
Balance Research Account Report Mission Outcomes
5. RESPONSIBILITIES
5.1 Study Funding Agreements, Implementation (see attached)
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.
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