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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).

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 Jeanne Eull at 612-624-8475 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, Jeanne Eull (jeull@umn.edu, 612-624-8475) 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.

Medical School Assistant Professor Aaron Kelly, PhD, and Jennifer Abuzzahab, MD, Children's Hospitals and Clinics of Minnesota, received a Community Collaborative Grant from CTSI in 2010 to study the effects of the drug exenatide on extreme pediatric obesity. On Monday, February 4, the encouraging results of that study were published online in JAMA Pediatrics. 

Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist currently approved for adults with type 2 diabetes. Dr. Kelly and his team conducted a three-month, placebo-controlled trial followed by a three-month open-label extension where medication was offered to all participants. 22 individuals between 12 and 19 years of age completed the trial. Participants who received exenatide experienced a greater reduction in BMI compared with placebo (-2.7 percent), and a further reduction in BMI during the open-label period (cumulative reduction of 4 percent). The team also observed a reduction, though not statistically significant, in systolic blood pressure. 

The authors conclude that "...data from the current study provide evidence that GLP-1 receptor agonist treatment reduces BMI and elicits a potentially meaningful reduction in SPB in adolescents with severe obesity." Kelly's team collaborated with Kyle Rudser, PhD, of the CTSI Biostatistical Design and Analysis Center to complete the analysis and interpretation of the data; Rudser is also an author of the JAMA Pediatrics article. 

The CTSI Community Collaborative Grants are meant to generate pilot data for further research and funding. The authors discussed future directions for this line of research, concluding that future clinical trials should be conducted over a longer duration and should look at other health outcomes, beyond BMI and systolic blood pressure. The study was covered by Reuters and U.S. News and World Report, among others.

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.

Meet CTSI recruitment specialist Melissa Mueller, whose expertise and experience make her a critical member of research teams at UMN. Her work with ResearchMatch is connecting University of Minnesota researchers with volunteers who have expressed interesting in participating in research studies.Thumbnail image for head shot.jpg

Why do you work in clinical and translational research?
I chose to pursue a job in clinical and translational research because I recognize its importance in simple everyday things we often take for granted, as well as its role in developing cutting edge methods that change how we view health and disease.

What does your typical work day at CTSI look like?
Since this is a new position for me as well as for the University, my "typical" workday is still in development. As each day passes, however, it becomes clearer that my position will likely not have "typical" workdays, which makes me really excited! Some days I meet with researchers to discuss recruitment goals for their study and develop targeted strategies. Other days I give presentations to different groups on campus, teach researchers how to use ResearchMatch, work with the IRB to streamline certain procedures for our researchers, attend community outreach and networking events, participate in discussions on various health topics across the Academic Health Center schools, help develop training materials, host internal meetings, collaborate on nation-wide efforts to promote research volunteer participation, and continue to learn about the dynamic world of research at the University. I am lucky to work on such a wide variety of projects and with very intelligent and diverse people!

What do you like to do when you're not at CTSI?
When I am not at CTSI, I enjoy outdoor activities (especially running!), traveling, exploring the nooks and crannies of the Twin Cities, and spending time with my family and friends.

What is your favorite or current read?
I just finished reading Unbroken: A World War II Story of Survival, Resilience, and Redemption by Laura Hillenbrand. It was great! Next, I'm starting No Time To Lose: A life in pursuit of deadly viruses by Peter Piot.

Favorite quote?
Many of my favorite quotes come from my friends and family so I'll share one that is a bit more recognizable: "Be yourself; everyone else is already taken." -Oscar Wilde