CTSI News

How to acknowledge CTSA support

2013-04-12T19:03:25Z

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).

CTR Portal Enhancements

2013-04-11T15:02:41Z

New enhancements for the CTR Portal have been released that allow study staff to have more direct interaction with individual project records.

New features for updating project records include:

- Adding/inactivating personnel
- Attaching documents
- Adding notes

Additional new features are available for managing project chart strings. This access is limited to individuals with Principle Investigator, Invoice Contact, or Account roles on a project.

- Adding chart strings to the project
- Assigning chart strings to invoice charges
- Using multiple chart strings to pay for a specific service

If you have questions or need assistance, please contact us at ctsi@umn.edu or 612-625-2874.

Implementation of enterprise-wide Clinical Trials Management System begins

2013-03-07T21:26:47Z

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.

New hours of operation at CTSI clinical research units

2013-03-07T18:35:34Z

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.

CTSI funds cross-institutional research in health disparities and health systems change

2013-03-06T20:59:02Z

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

Community Collaborative Grant recipients published in JAMA Pediatrics, results garner media attention

2013-02-05T22:29:04Z

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 offers a better way to collect and manage research data

2013-02-05T18:44:24Z

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.

Congratulations to CTSI career development award recipients!

2013-01-30T21:52:05Z

Please join us in congratulating nine new Clinical and Translational Science Institute scholars, recipients of career development awards designed to support junior investigators as they build independent research careers.
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The New Investigator Pre-K Pilot Grant provides mentorship, oversight, and pilot funds to junior investigators interested in clinical and translational research. The program is designed to prepare investigators to successfully compete for NIH K or R awards.

Naomi Duke, Division of Adolescent Health and Medicine, Pediatrics, Medical School
Identifying Mechanisms for Health Disparities: Exploring the Impact of Youth Survival Expectations on Future Health

Stephanie Misono, Department of Otolaryngology, Medical School
Development of online intervention for distressed voice-disordered patients

Rebecca Shlafer, Division of Adolescent Health and Medicine, Pediatrics, Medical School
Nutritional Status and Unmet Needs among Incarcerated Women of Reproductive Age
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The K to R Transition Grant aims to place junior investigators, who have K awards, further on the path to be competitive for R01 awards.

Cari Clark, Department of General Medicine, Medical School
Impact of Yoga on Violence Survivor's Mental and Cardio Metabolic Health: A Feasibility Study of a Cluster Randomized Trial

Terri Laguna, Divsion of Pediatric Pulmonary Medicine, Pediatrics, Medical School
Biomarkers of Injury and Destruction in the Cystic Fibrosis Lung
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The R to R Pilot Grant provides research funds for first time R01 awardees in clinical and translational research or funded junior faculty in the basic sciences who need pilot data to transition to translational work. This program provides supplemental funds to ensure that awardees compete successfully for a second NIH R01.

Alvaro Alonso, Division of Epidemiology and Community Health, School of Public Health
Comparative Effectiveness of New Oral Anticoagulants in Atrial Fibrillation

Robert Jones, Division of Pediatrics, Developmental/Surgical Sciences, School of Dentistry
Examining Combination Antimicrobial Therapies to Control Pathogenic Oral Biofilms in Young Children

Erik Peterson, Division of Rheumatic & Autoimmune, Medicine, Medical School
PTPN22: genetic determinant of vaccine efficacy

Marnie Peterson, Division of Experimental and Clinical Pharmacology, College of Pharmacy
Alpha toxin: Role in biofilm formation by MRSA wound isolates and therapeutic target

CTSI connects with Melissa Mueller, recruitment specialist

2012-12-27T00:21:45Z

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.

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

Recipients announced - Fall 2012 Translational Grant Awards

2012-12-18T14:46:33Z

Congratulations to the recipients of CTSI's Fall 2012 Translational Grant Awards! This round of awards, designed to facilitate the highest quality translational research, was dedicated to junior investigators at the University of Minnesota.

Funded investigators will partner with a Project Development Team from the CTSI Office of Discovery and Translation (ODAT) that will provide project mapping and translational research expertise to facilitate the achievement of specific metrics and endpoints.

Peter Dosa, PhD, College of Pharmacy, Department of Medicinal Chemistry, Institute for Therapeutics Discovery and Development
Development of novel therapeutics for glaucoma

Michael Linden, MD, PhD, Medical School, Department of Laboratory Medicine and Pathology
Identifying immunophenotypic markers suitable for clinical laboratory testing for early identification of bortezomib resistance in human multiple myeloma

Ann Parr, MD, PhD, Medical School, Neurosurgery Department
Autologous OPCs for transplantation into human spinal cord injury

Valerie Pierre, PhD, College of Science and Engineering, Department of Chemistry
Siderophore aptasensors for immediate point-of-care diagnosis of urinary tract infection

Visit the CTSI website to learn about current and future funding opportunities.

Enhancing Community Organizations

2012-12-10T17:32:09Z

We would like to congratulate the individuals from the 11 organizations that participated in the inaugural cycle of the Community Research Institute! Everyone who participated received a certificate and was recognized for all of their hard work. The following is a list of organizations that participated in this year's institute.

ACER
Becker County Human Services
Canvas Health
Capernaum Pediatric Therapy Inc
Children's Defense Fund
Comunidades Latinas Unidas En Servicio (CLUES)
Family Tree Clinic
Lao Assistance Center of Minnesota
Minnesota Department of Education
Minnesota AIDS Project
SoLaHmo Partnership for Health and Wellness

The CRI is a 6 week workshop series aimed at enhancing the capacity of community organizations to partner and conduct health related research. Participants develop their skills in relevant research methodologies, develop an understanding of appropriate resources available to assist them with carrying out health research, apply these skills and knowledge to a real-world project, and network with other community-based and university-based researchers.To learn more about upcoming cycles of the CRI, please contact ctsi@umn.edu.

Community Research Institute participant Dr. Castellanos featured in Twin Cities Daily Planet

2012-11-28T18:59:04Z

As an immigrant himself, Dr. Jose William Castellanos has a particular passion for working with immigrant Latino communities.

"People with professional backgrounds usually leave this area, but I find that I'd prefer to give back," he said, explaining his motivation in the Twin Cities Daily Planet.

The Community Research Institute has worked with Castellanos to further his dedication to the Latino community by providing training, tools, and technical assistance to develop his research. With this partnership, Castellanos works towards lessening the gap between the health status of the U.S. population and the health status of immigrants.

We are proud of Dr. Castellanos' work, read more about it here.

Dr. Sarah Cooley to serve as Director of Academic Clinical Research Information

2012-11-05T16:05:49Z

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.

U of M professor awarded prestigious American Cancer Society research award

2012-11-02T15:15:24Z

Congratulations to David Largaespada, Ph.D., professor in the departments of Genetics, Cell Biology and Development and Pediatrics, for being awarded the prestigious American Cancer Society (ACS) Research Professor Award.

Largaespada, who has used the Sleeping Beauty transposon to identify and better understand cancer genes, is only the second University of Minnesota faculty member to receive the award.

Researchers interested in using this technology should contact the CTSI Office of Discovery and Translation. Several CTSI grant mechanisms, which are closed at this time, could be used to support projects using this technology. Please contact Sandra Wells, PhD, Assistant Director of the CTSI Office of Discovery and Translation at smwells@umn.edu to learn more about future funding cycles.

Institute of Medicine elects CTSI director Bruce Blazar, MD as new member

2012-10-17T14:27:50Z

The Institute of Medicine (IOM) elected 70 new members and 10 foreign associates during its 42nd annual meeting, including Clinical and Translational Science Institute director Bruce Blazar, M.D. Election to the IOM is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

"The Institute of Medicine is greatly enriched by the addition of our newly elected colleagues, each of whom has significantly advanced health and medicine," said IOM President Harvey V. Fineberg. "Through their research, teaching, clinical work, and other contributions, these distinguished individuals have inspired and served as role models to others. We look forward to drawing on their knowledge and skills to improve health through the work of the IOM."

New members are chosen through a competitive selection process by current members. Criteria such as major contributions to the advancement of the medical sciences, health care, and public health are considered.

Join us in congratulating Dr. Blazar on this prestigious honor!