Vol. 2 | September 2021 – 4 minute read

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New Associate Vice President of Clinical Research

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Following a national search, Bhanu Pappu, Ph.D., will join UT Southwestern as Associate VP of Clinical Research, effective Nov. 1. He will oversee operational, financial, and regulatory processes related to clinical and translational research, and guide personnel functioning in clinical and translational research at UT Southwestern and affiliated institutions.  

 

Dr. Pappu joins us from the UPMC Hillman Cancer Center in Pittsburgh, where he served as Vice President of Clinical Research Operations and Strategy. Before joining the University of Pittsburgh Medical Center, he was Director of the Clinical Cancer Genetics program at the MD Anderson Cancer Center in Houston.  

 

A trained cancer researcher and signal transduction researcher, Dr. Pappu brings over 21 years of professional experience in the health care industry, including basic science research and management, clinical trial administration, and clinical operations in a large academic cancer center and multispecialty health system. 

 

At the Hillman Cancer Center, he directed the reorganization of the Protocol Review and Monitoring System and the Clinical Protocol and Data Management functions for the competitive renewal of the National Cancer Institute’s Cancer Center Support Grant, resulting in ‘Outstanding to Exceptional’ merit.   

 

Dr. Pappu designed new career ladders for clinical research personnel, improving staff retention by 50%, spearheaded transition of the institution’s clinical trials management system (CTMS), and dynamically improved the financial bottom line for clinical research operations. His strong analytical and interpersonal skills helped him enhance the organizational structure and efficiency of the Clinical Trials Office.

 

Dr. Pappu completed a doctoral degree in tumor immunology from the State University of New York at Buffalo, and a Master of Healthcare Administration at the University of Houston-Clear Lake.  

 

His scientific and business background – as well as his proven success leading multidimensional projects that include basic, translational and clinical research, fellowship training programs, and clinical operations – will be an asset as we expand UT Southwestern’s clinical research enterprise. 

Updates on Billing Projects

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Over the past few months, the Office of Clinical Research has initiated multiple projects focused on improvements to clinical research billing, budgeting, and invoicing. 

 

New Research Billing Review (RBR) 

The departments of Urology, Gynecologic Oncology, and Neurology are piloting a new RBR process that leverages Epic research functionality. It allows study teams to electronically manage patient timelines and treatment activity for their clinical trials. The charge review process of RBR will be centrally managed by the Revenue Cycle team, thus eliminating the manual review by study teams. This functionality will be rolled out to the rest of the institution during the fall and winter of 2021. For more information, contact John Beaver, Assistant Director, Clinical Research Operations.  

 

Sponsor Invoicing in PeopleSoft

We are transitioning sponsor invoicing to UTSW’s financial system of record, PeopleSoft PSFT 9.2. This will allow for timely accounting of revenue earned on behalf of clinical trials and ensures investigative teams have timely revenue recognition. This transition has already begun and is slated for completion by Oct. 1. For more information, contact Megan Marks, Assistant Vice President, Sponsored Programs Administration.  

 

New Single Billing Office (SBO) Statement 

The new SBO statement will provide clinical research departments with a comprehensive monthly billing statement for their research study, combining hospital charges and professional charges associated with the applicable research study. Coupled with the RBR process, the SBO statement streamlines the payment of hospital and provider services for a research study and eliminates the laborious and time-consuming payment process. It is set to launch in mid-October. For more information, contact Kelly Kloeckler, Associate Vice President, Revenue Cycle Operations.  

 

By upgrading and optimizing our use of technology with Epic, Velos, and PeopleSoft; investing in skilled people; and improving our processes; we will improve research billing compliance and efficiency while minimizing study team manual work on billing reviews and data entry.  

CTSA KL2 Clinical Scholars Announced

We are proud to announce our new KL2 Clinical Scholars: Drs. Cherise R. Chin Fatt, Christina Herrera, Sarah R. Lieber, Samuel McDonald, Eric B. Ortigoza, and Yuanyuan Faith Zhang. These six scholars were selected from a group of 34 highly qualified applicants. 


The KL2 Clinical Scholars Program is designed to provide research and career development support for junior faculty engaged in clinical research. The two-year program, funded as part of our recent NIH Clinical and Translational Science Award (CTSA), provides 75% salary support, customized training and mentorship.  

 

The goal is to give scholars time and resources to develop their research and be ready to transition into independently funded scientists. The program launched Sept. 15 under the direction of Drs. Keith Argenbright, Heidi Jacobe, Maduhkar Trivedi, and Helen Yin.



Please direct comments on the program to Helen Yin, Ph.D., Professor of Physiology and Faculty Diversity & Development, and Associate Dean, Office of Women’s Careers. 

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Cherise R. Chin Fatt, Ph.D. Psychiatry

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Christina Herrera, M.D. Obstetrics and Gynecology

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Sarah R. Lieber, M.D., M.S.C.R. Internal Medicine

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Samuel McDonald, M.D., M.S. Emergency Medicine

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Eric B. Ortigoza, M.D., M.S.C.R. Pediatrics

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Yuanyuan Faith Zhang, M.D., Ph.D.

Radiation Oncology

Changes to the eIRB System

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In an effort to decrease regulatory burden, the Human Research Protection Program (HRPP) made the following enhancements to the electronic Institutional Review Board system (eIRB): 

 

Elimination of the requirement that co-Investigators take action in eIRB before IRB submission 

Until recently, co-Investigators on a project were required to accept participation before the IRB application was considered complete for submission. This requisite sometimes caused delays in submissions to eIRB and therefore delayed the overall approval timeline. Moving forward, we have streamlined the process by eliminating this requirement.  

 

Study personnel (with the exception of PI) may be added or removed at any time 

Changes to study personnel may occur at any time, even if there are open modifications or continuing reviews. When personnel are added, eIRB reaches out to the Collaborative Institutional Training Initiative (CITI) to confirm the training is current (depending on the type of study). If training cannot be confirmed by the system, an error message will appear. Once personnel have been added, the changes are effective immediately and no longer require IRB Office review.  

 

Form B updates are only required at continuing review/annual update for eIRB LITE studies Previously, all study personnel changes required an updated Form B. To reduce the additional burden, the HRPP decided to only require updated Form B submission with continuing review/annual updates. If your study does not have an approved Form B (studies created before August 2018), you are not required to create and submit one.  


The HRPP Department is always working to make improvements to the electronic system and IRB review process. If you have questions about these changes or have suggestions, email HRPP@utsouthwestern.edu.    

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