Recently in Biomedical Health Informatics Category

By receiving the Clinical and Translational Science Award, the University of Minnesota is now required by NCATS and NIH to ensure an acknowledgment of the CTSA in any publications that result from UMN CTSI assistance with a project.

How to acknowledge CTSA support
All publications resulting from the use of CTSI resources are required to credit CTSA by using the text below.

Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

When to acknowledge CTSA support
Please note that assistance is not limited to monetary support (e.g., pilot grant funds), but also includes use of CTSI space, consultation with CTSI faculty or staff, and use of any CTSI Internal Service Organization services (Project Management, Clinical Research Coordinators, Nursing and Nutritional Services, Biostatistical support, and Regulatory assistance such as IND/IDE support, clinical trial monitoring, or ClinicalTrials.gov support).

The University of Minnesota is beginning the process of implementing OnCore® from Forte Research Systems as a single enterprise Clinical Trials Management System (CTMS). The solution will be University-hosted and will support a broad range of clinical research, from the Clinical and Translational Science Institute research units, to cardiology, oncology, public health, pediatric medicine, and other University health-research programs.

The CTMS addresses a campus-wide need for better support of cancer trials, pharmaceutical clinical trials, device studies, case report studies, multi-center studies, and large-scale epidemiological studies. It is designed to enhance the efficiency and quality of health research at the University of Minnesota by:

• Reducing the cost of redundant software infrastructures
• Consistently capturing and tracking protocol, study, administrative, and financial data needed for management of trials
• Increasing the capability to provide meaningful reports and data regarding the financial status of a study to Principal Investigators
• Reducing costs to manage clinical research within individual units
• Reducing multiple isolated, informal environments for managing and tracking study data
• Improving regulatory compliance

"The CTMS is critical to our continued success as a leader in health research," explains Brian Herman, vice president for research. "Using a single, centrally supported system to manage our clinical research enterprise allows us to achieve new efficiencies, eliminate redundant processes and, ultimately, translate our discoveries into better health, faster. It's a great example of President Kaler's operational excellence initiative in action."

The enterprise CTMS is supported by the CTSI, which is part of the national NIH-funded Clinical and Translational Science Award program. Biomedical Health Informatics Director Connie Delaney notes, "The CTMS has been a consistent and core need for our research enterprise and in partnership with CTSI, the Office of Biomedical Health Informatics has formed an expert, experienced inter-professional team to create the UMN enterprise CTMS to meet operational excellence objectives, ensure successful implementation and ongoing sustainability." The system will be rolled out in phases, with the Medical School Division of Cardiology, the Masonic Cancer Center, and Pediatric Oncology among the first users. CTSI director Bruce Blazar explained, "Through the Biomedical Health Informatics team, we've been listening closely to faculty and staff about what systems and tools are needed on campus. We've heard overwhelmingly that we need to reduce duplication of effort, provide user-friendly financial and administrative reports, offer better support for meeting regulatory requirements, and reduce overall costs associated with managing clinical research. The CTMS is key to meeting those needs, not just within the Academic Health Center, but for all those conducting and supporting health research across the University."

The implementation team is collecting and posting answers to Frequently Asked Questions on the Biomedical Health Informatics website, and the Clinical and Translational Science Institute's monthly e-newsletter will feature regular updates and announcements about the project.

Questions about CTMS should be directed to Josh Fehrmann, project manager, at jaf@umn.edu.

REDCap, or Research Electronic Data Capture, has taken off at the University of Minnesota. REDCap is a software application that provides secure, web-based data entry for clinical studies and a user-friendly interface to create online surveys and databases. 

REDCap was created at Vanderbilt University and is now being used by 549 institutions in 50 countries including the University of Minnesota Clinical and Translational Science Institute (CTSI). Within the University and CTSI, there are now almost 600 users taking advantage of REDCap's innovative features, compared to 188 just one year ago.

"I switched to REDCap from Microsoft Access and Infopath and have been wishing I had done it sooner," said Lynda Polgreen, M.D., M.S., Assistant Professor of Pediatrics. "REDCap is a user friendly database system. I can more easily review data, develop reports for a regulatory agencies, import and export data. REDCap has saved me a lot of time that used to be spent developing and trouble shooting Access and Infopath. In addition, I save time because my study coordinator was able to quickly learn to use REDCap and I anticipate she will be the primary database manager soon."

Not only does REDCap make it easier to adopt innovative practices, but it is fully supported by the CTSI's Biostatistical Design and Analysis Center and Biomedical Informatics teams. Use of REDCap is available at no cost to research teams, and additional assistance from a database developer is available at an hourly rate. Database programmer and analyst Sue Lowry provides bi-weekly introduction sessions to REDCap and is available to provide ongoing support. 

"CTSI staff were very willing and available to train my project staff who actually used the program," Kola Okuyemi, M.D., M.P.H. said. "They were readily available for trouble shooting, and Sue Lowry was great!"

Lowry and CTSI team members guide users through application upgrades. In 2012 these included a new randomization module, automated approval of changes to production projects, and new display options for survey answers. REDCap continues to evolve with an upgrade scheduled for later this year.

REDCap is used across a broad range of research studies at the University of Minnesota and around the globe.  If you are interested in learning more, register to attend a REDCap demonstration held the first Thursday and third Wednesday of every month.

The Clinical and Translational Science Institute (CTSI) and the Biomedical Health Informatics (BMHI) team have jointly appointed Sarah Cooley, MD, MS, to a newly created position, Director of Academic Clinical Research Information. Dr. Cooley, Assistant Professor in the Division of Hematology, Oncology and Transplantation, also serves as Director of Medical Informatics and Services for the Masonic Cancer Center.

In this new role Dr. Cooley will work with CTSI, BMHI, the AHC Information Exchange (AHC-IE), AHC Information Systems, and the research community to develop a high quality and efficient informatics platform. Dr. Cooley will ensure that user requirements are central to all solutions developed by this collaborative team, which aims to create a clear user-centric pathway to access informatics and research analytics support alongside traditional research support services such as nursing, regulatory, and biostatistics. She will also participate with Fairview, University of Minnesota Physicians and AHC-IS on an Epic Optimization effort, and will develop metrics to evaluate the quality and value of informatics systems and tools.

Please contact Dr. Cooley directly at cool0023@umn.edu or 612.625.8474 with questions.

Are you looking for a more efficient way to capture and manage your data? CTSI may be able to help with REDCap (or Research Electronic Data Capture), a secure web application designed exclusively to support data capture for research.

REDCap is available to UMN research teams at no costs, and this tool is fully supported by the Biostatistics Design and Analysis Center (BDAC) at CTSI. The BDAC team offers regular introduction sessions to help you determine if this is the right tool for your study. Contact CTSI for more information or visit the UMN REDCap website learn more.