Welcome to the inaugural edition of Clinical Research Update!

This newsletter is designed to keep researchers abreast of our institution's latest developments in clinical research at UT Southwestern. It aims to inform faculty and staff of recent changes in research resources, processes, and policy, as well as to provide spotlight summaries on specific areas of our clinical research infrastructure.

I hope this will be a welcome addition to your inbox and encourage you to share your story ideas and overall feedback. Together, we can transform clinical research and reach new levels of excellence at UT Southwestern!  

Sincerely,

Eric Peterson, M.D, M.P.H.

Vice Provost for Clinical Research

Sponsored Programs Administration (SPA) and the Office of Clinical Research (OCR), are working collaboratively to improve the financial management of clinical research studies.  

The following project components are slated for inclusion in the initial roll-out:  

Implementation of Standard Budgets and Central Budget Review 

SPA has created a standard workbook tool to allow study teams to easily consider and compile trial budget inputs. This tool will suggest common study ideas, provide usual and customary charges for various inputs, and provide multiple spreadsheet options for negotiating with sponsors who hold specific preference as to how costs are represented. Investigators can also use these standard templates to expedite a central review of their study budgets to ensure all required costs are included and communicate any concerns where a proposed budget may yield significant deficit. This tool will allow study teams to make informed financial decisions about their studies. 

Shift Research Finances to Accrual Accounting 

UTSW is changing its accounting mechanisms for clinical research from traditional cash-basis accounting to accrual-basis accounting. This shift is not only consistent with best practices and accounting principles but will benefit the PI/Study Team by allowing expenses to be immediately recorded to the respective clinical trial project ID, rather than awaiting cash receipt from sponsors. This will also facilitate up-to-date financial reports for a given study allowing for review of expense-to-revenue and actual-to-budget results. 

Use of Distributed Billing Clinical Trial Invoicing Tool 

The institution is also moving to promote use of PeopleSoft for direct invoicing to sponsors at the department level and through the financial system of record for clinical trials. This change will benefit the PI/Study Team in that it will be easier for the institution to route revenue from the sponsor back to the appropriate study budget in a timely fashion.   

Availability and Monitoring of Profit & Loss (P&L) 

Historically, we have not been assessing longitudinal P&L at the study level. Instead, we had to wait until revenue was recognized which resulted in significant time delays. This switch to the central financial system will afford the PI/Study Team a singular, central tool for creation/tracking of invoices and real-time assessment of the health of the study.  

These needed and important changes for our institution will empower our clinical researchers with more accurate and timely financial data. We will be working closely with the researchers and departmental divisions as we roll this out. If you have questions, please do not hesitate to reach out at any time through ServiceNow.  

The James W. Aston Ambulatory Care Center is currently undergoing an extensive renovation and expansion. The effort will refresh and redesign research space, work areas, and the patient lobby on the ninth floor.

The first phase of the redesign was recently completed, with relocation of the institution's Clinical Research Unit (CRU) and the Neuroscience Translational Research Center (NTRC) in July 2021. Further research space expansions are slated to be completed by the end of the year, resulting in a total of 38 exam, procedure, and consult rooms. This new expanded research facility will support the Dallas Heart Study, as well as clinical studies from the departments of Internal Medicine, Physical Medicine and Rehabilitation, Ob/Gyn, Urology, Surgery, among others.

These improvements will not only optimize clinical research-related facilities for our faculty, but also will make the research experience more pleasant for participants. 

For more information or questions on Aston CRU, contact John Beaver, John Beaver, M.P.A., M.Ed., CCRP, M.Ed., CCRP, Assistant Director, Office of Clinical Research Administration.

The Clinical and Translational Science Award (CTSA) at UT Southwestern is a $46 million, five-year National Institutes of Health (NIH) grant administered through our Center for Translational Medicine (CTM). The CTSA grant recognizes the effectiveness of our institution’s scientists and our growing clinical network to create a vibrant, translational research training and clinical care environment. 

Our CTSA hub, consisting of UTSW and our partnering institutions, is designed to expand the scope and depth of our clinical and translational research enterprise beyond our campus to improve the health of local, regional, and national communities.   

The overarching goal of the CTSA at UT Southwestern is to accelerate the translation of scientific discovery into changes in clinical practice that improve health. As such, it provides resources to support existing and new innovative research programs and resources.  



Key new resources of the CTSA include:  

• Innovative informatics tools for analyses of big data from basic to population science.  
• Advanced biostatistical methods for quantitative and qualitative research to ensure rigorous scientific study design.
• Streamlined regulatory procedures and processes to accelerate clinical research study start up.
• Multiple resources to engage underserved and underrepresented populations in the design and conduct of clinical research.
• New methods for advancing multi-site clinical trials, support for new potential drugs, and devices.  
• New research education and training programs in clinical research.  
• Entrepreneurship for the investigators and their team members.  
• Training programs in team science.  
• Pilot grant awards for investigators to obtain preliminary data for new research ideas.  
• Preclinical drug development.  
• Metabolomics and lipidomics. 

For questions regarding the CTSA, please contact Robert Toto, M.D., Professor, Internal Medicine – Division of Nephrology. 

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