March 2013 Archives

The University of Minnesota is beginning the process of implementing OnCoreĀ® 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.

Beginning Monday, March 11th, 2013 new hours of operation will be implemented in the Masonic Clinical Research Unit (MCRU) and Delaware Clinical Research Unit (DCRU).

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Masonic Clinical Research Unit (MCRU)
Under the new schedule all visits at MCRU must be scheduled at least one week in advance so that we can make sure that appropriate staffing is available to meet your needs. If for some reason you cannot schedule a week in advance, please contact MCRU staff at 612-624-0104 to see if we can accommodate your request.

Monday-Friday      7:00 AM - 7:00 PM
Saturday               7:00 AM - 12:00 PM
Sunday                 Closed

Delaware Clinical Research Unit (DCRU)
Contact DCRU staff at 612-624-4423.

Monday-Friday      7:30 AM - 4:00 PM

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These changes are being made in an effort to develop a sustainable financial model of operation for the CTSI units without significantly affecting customer research programs. Currently, the vast majority (>95%) of all work in the clinical research units fall within the new scheduled hours of operation.

If your research visits are absolutely unable to fit within our revised hours of operation, please contact Clinical Research Implementation Services (CRIS) Manager Brenda Prich at prich036@umn.edu or 612-625-2723 a minimum of 2 weeks prior of your expected needs to discuss.

We are sorry for any inconvenience that this may cause.


Frequently Asked Questions

Q: How were these hours of operation selected?
A: We have analyzed the appointment volume in our facilities over the past few years. The new proposed hours cover 95% of the appointment hours scheduled over the last 6 months. Therefore, we can ensure coverage for the most customers by ensuring we are open & staffed during these hours.


Q:
Why is this change being made at this time?
A: We are making this change for several reasons:

  • In our effort to operate in a more efficient model, we are seeking opportunities to optimize staffing and operational costs. By reducing the hours of operation, we both decrease the staffing required to operate our facilities and increase the coverage/staffing during our busiest times (hopefully resulting in decreased wait times, more back-up coverage, and improved customer service/quality).
  • We are currently experiencing some unanticipated staff leaves. This provided us with the momentum and opportunity to make changes to our operational structure.

Q: Are your rates changing as a result of these operating model changes?
A: No, service rates will not be changing. Rates changes occur on a fiscal year basis (next rate changes will occur July 2013). We are continuing to seek opportunities to improve our rates and rate structure, along with our overall CTSI financial operating structure. If you have questions specific to CTSI rates and the ISO rate structure, please reach out to Lisa Johnson, Senior Operations Officer (lisaj@umn.edu, 612-624-9159) or David Bremseth, Clinical Research Integration Officer (dbremset@umn.edu, 612-624-4759).


Q: My study requires evening/overnight or weekend appointments, what do I do?
A:

  • If your study requires special accommodations outside our normal hours of operations, please contact the CRIS Clinical Manager, Brenda Prich (prich036@umn.edu or 612-625-2723) at least 2 weeks in advance so that we can review the request and determine if we will be able to accommodate your service needs.
  • For existing studies, with appropriate notice, we will honor our commitments for any appointments that must occur outside normal operating hours. However, we would ask you to help us assess if there are options that would enable your appointment to occur within our normal hours of operation.
  • For new studies, we will be reviewing service needs outside the normal hours of operation based on your CTSI Request for Services.


Q: Why am I now required to schedule appointments 1 week in advance at MCRU or go through the MCRU Clinic Desk Staff?
A: Controlling the schedule 1 week in advance allows us to better manage our staff capacity and schedule between our facilities and offsite obligations. We can shift staff between hours and facilities based on where we have the heaviest volume and based on the complexity of the services. Based on our review of staff scheduling processes, we feel that the 1 week window provides us with the appropriate time frame to adjust our resources.


Q: I enrolled a subject at the last minute or just had an appointment cancellation or rescheduling, but I'm within the 1 week window to use MCRU. What do I do?
A: Please contact the CRIS Clinic Desk Staff (MCRU 612-624-0104). Our staff will be able to help identify available appointment times, reschedule appointments and provide alternate options if there is no available capacity during your proposed time. We expect that we will still be able to accommodate most requests within the 1 week window provided they fall within our normal hours of operation.

The University of Minnesota and the University of California - Los Angeles Clinical and Translational Science Institutes have teamed up to support three new pilot projects that address health disparities and health systems problems in Minnesota and southern California.

The Cross-Institutional Award for Health Disparities Research and Health Systems Change funds research where community-based organizations participate fully with faculty in the research process, and projects include co-Principal Investigators from both UMN and UCLA.

Please join us in congratulating the recipients of this inaugural round of funding!

  • William Riley, UMN, for the HIE Use project with Hector Rodriguez and Jeffrey McCullough, UCLA
  • Joshua Chodosh, UCLA, for the Alzheimer's Disease project with Joseph Gaugler, UMN
  • Robert Jones, UMN, for the Dental Caries/Obesity project with Francisco Ramos-Gomez, UCLA