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, unsecure 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.

Submitted by Meredith Fisher, Communications Director, Clinical and Translational Science Institute.

Effective immediately, signatures of co-investigators and department heads are no longer required on hard copy or email submissions. Note that principal investigators are still required to sign hard copies before submitting; PI signatures are also required for applications that are emailed by someone other than the PI.

All researchers listed on protocols automatically receive an email when an application is entered in the IRB database. As per the email instructions, researchers should contact the PI if they believe they have been added to a study in error or without consent.

Questions? Contact the IRB office at 612-626-5654 or irb@umn.edu.

Post by Eric Vegoe, info tech professional, Human Research Protection Program

eProtocol is a critical step toward establishing a technology infrastructure capable of addressing the research community’s current and emerging needs. The system will be implemented in three releases, allowing for comprehensive technical support during the transition. Researchers and staff will see a number of benefits, including:

Intuitive online interface with dynamic, question-based forms
Streamlined administrative processes
Ability to modify and edit drafts, pause form completion and continue later
Forms that can be completed by someone other than the form signatory
Reporting and email notification features

Release dates are subject to change.

Release 1: Fall semester 2012
Institutional Animal Care and Use Committee
Institutional Biosafety Committee
Controlled Substances

Release 2: Spring semester 2013
Institutional Review Board

Release 3: Fall semester 2013
Unfunded Research Agreement post-approval review and compliance modules

Learn more

Based on input from faculty, we have re-engineered the reports available to faculty, improving visibility, utility and performance. We’re pleased to announce that these new reports are now available for use. You can access them via UM Reports in a new section designed for faculty/PI financial reporting; instructions on how to use the reports are available here. The reports, which now combine sponsored and non-sponsored account data as well as payroll data,  provide users with the option of reviewing high-level categorical summaries or drilling down into data to the level of individual transactions. We’re confident that these changes will significantly improve access to account data, thereby assisting faculty in managing their accounts in a thorough and timely way.

Over the summer months, other aspects of the EFS improvement initiative have also seen significant progress. A pilot of a new business intelligence (BI) tool will start soon. The BI toolset, known as UM Analytics, will enable users to create standardized and custom reports and will offer analytical capabilities for forecasting and predictive modeling.  A representative group of volunteers from various employee groups, business roles and colleges/departments has been recruited to participate in the 3-month-long pilot, focusing on financial reporting.  Ultimately, the additional analytical capabilities of the BI tool will complement the improvements made in the new suite of reports.

As with the implementation of any major system, the list of fixes and requests for changes (often referred to as “the punch list”) is lengthy.  The EFS implementation has been no different.  To help with evaluation and prioritization of these many items, we have appointed a committee of experienced end-users to advise the EFS team on functional needs and offer recommendations for further improvements.  The Financial System User Network (FSUN) Board has also reviewed the current list of items on the punch list and provided recommendations on the priorities from their members’ perspective.  These groups have already identified beneficial improvements and continue to work with us as we prioritize additional needs and fixes.

We appointed a group of 10 senior finance managers from across the university to conduct a review of the fundamental decisions made and implemented with EFS, including design elements such as: the structure of the chart of accounts; system workflows, particularly those related to purchasing; and interfaces with EFS. They’ll offer their recommendations for possible design modifications that might improve performance and make the system more efficient.  The committee is already working with OIT to identify and eliminate system performance bottlenecks for processing high-volume transactions.

We hope that the improvements to date will aid faculty and staff in performing their roles and responsibilities.  We also want to express our immense gratitude for your ongoing patience and continued commitment to helping us improve the EFS system.  We appreciate the level of your engagement in our efforts, and we’ll keep you apprised about further developments as this important project  continues.

Stay tuned.

Enhanced eRA Commons

Research Performance Progress Report

Although the Food and Drug Administration requires registration for certain trials involving drugs, biologics, and devices, the International Committee of Medical Journal Editors requires public registry of all clinical trials before publication.

CTSI can help researchers navigate the ClinicalTrials.gov data system to register, submit, maintain, and update study information. CTSI’s coordination helps maintain FDA compliance and ICMJE requirements to minimize multiple registrations of the same data. Contact Kathy Mischke to register your trial and visit the CTSI website for more information about regulatory support services.

• Effort statements can be viewed in ECRT as they are building throughout the Period of Performance.
• Researchers (or their PI’s) will certify effort statements first, before statements are approved by the Effort Coordinator.
• A new option is available for PI’s to review and certify statements using a Group View.
• After statements have been certified by the researcher or Principal Investigator, the Effort Coordinator will make any necessary payroll adjustments and approve the statements.
• New online Certifier Tutorial is available to guide Certifiers through the new process.

Two new job aids have been created: one for all Certifiers and another one that is specific to PI’s who certify the statements of others.

Implementation timeline:

• Jan. 16, 2011 – Effort Reporting Period 2 ends (Pay Periods 7 – 16).
• Jan. 26, 2011 – Pay Period 16 posts, Pre-Review Period begins.
• Feb. 14, 2011 – Effort statements available for certification in ECRT System.
• March 11, 2011 – Effort certification due date.  Statements must be certified and approved by this date.

Questions should be directed to the Effort Certification Helpline at 612.625.7824.

Submitted by David Hagen.

A new, Web-based technology that will combine the functionality of numerous isolated, siloed compliance systems into a new, integrated compliance solution is being implemented by the Office of the Vice President for Research (OVPR) in conjunction with the Office of Information Technology (OIT). The eProtocol system will facilitate the research compliance process for researchers, management staff, technical teams, and reporting units by making a number of research compliance processes easier to use and manage.

Researchers and staff will see a number of benefits from eProtocol, including:

• Intuitive, Web-based interface with dynamic, question-based forms (“smart forms”)
• Elimination of repetitive data entry for common compliance processes
• Ability to modify and edit drafts, pause form completion and continue later, and forms that can be completed by someone other than the form signatory
• Reporting and email notification features

Key Solutions, Inc., was selected as the vendor for this project after a comprehensive screening process. Key Solutions has developed similar systems for University of California—Berkeley, University of Texas Health Science Center at San Antonio, and other institutions.

There will be opportunities for faculty and researchers to be involved in the project and provide input, including feedback sessions, design reviews, and functional testing. A page on the OVPR website provides information about eProtocol, a project timeline, and key project contacts.

The first researcher input sessions are scheduled for mid-December. An overview of the project will be provided, and attendees will be asked for their input on essential system functions and capabilities, and their definition of a successful system. Dates, times and locations are listed below; no RSVP is required.

• Fri., Dec. 17, 9-10 a.m.  Magrath Library (St. Paul)  Room 8
• Mon., Dec. 20, 11:30 a.m.-12:30 p.m.  Moos Tower Room 2-580
• Tues., Dec. 21, 9-10 a.m.  Walter Library Room 402 (available via UMConnect)

The eProtocol project is being undertaken by OVPR and OIT to better serve the needs of the University’s research community and to more effectively manage the significant volume increases that will accompany the continued growth of the University’s research enterprise. Input from faculty and researchers will be critical to the success of eProtocol, and we look forward to hearing from you as the project unfolds.

Please see the separate post for year-end closure information for research operations.

Sponsored Projects Administration (SPA)
Thursday, December 9, 5 p.m.
Deadline for fully signed PRF, Budget, and Statement of Work for Industry-Funded Agreements that the sponsor requires to be completed (fully executed) by December 31, 2010. Note that because these negotiations also depend on the industry sponsor, SPA cannot guarantee that these agreements will be executed by December 31, but SPA will make every effort to have these completed. Industry-funded agreement materials submitted after this date will be worked on as well, but they will be given lower priority.

Monday, December 20, noon
Deadline for proposals, subaward information, invoices, and other transactions to be submitted to SPA to ensure that processing can be completed by 5:00 p.m. on December 23, before the winter closure period begins.  SPA has purposely set this deadline as late as possible to allow investigators and departments as much time as possible to prepare materials. It is highly unlikely that any extensions to this deadline will be approved. Please note that the deadline requires submission of  “complete, ready-to-submit or process materials.”

If incomplete information (e.g., a proposal missing some of its required elements, or a PRF without all required signatures, or a subaward invoice missing the PI’s signature)  is submitted to SPA, those transactions will not be considered  to have met the deadline, and will most likely have to be deferred for processing until January 2011. Materials that are complete but contain errors that are caught during the SPA review process are not considered “incomplete,” but PIs and departments are reminded that departmental personnel need to be available to make corrections in a timely manner to ensure that processing can be completed by December 23. If possible, please submit materials earlier than this deadline.

SPA will, however, have an emergency contact person available (with signature authority)  to handle true emergencies–i.e., materials that could not have been reasonably submitted prior to the published cut-offs listed above. This contact person is not expected, however, to handle proposals or other materials that could reasonably have been submitted but were not turned in on time. SPA will request a description of the nature of the emergency when the emergency contact person’s services are needed. Information to access this emergency contact person will be announced closer to the winter closure period.

See the SPA website for more detailed closure information and procedures.

Human Research Protection Program (HRPP)
The HRPP office will be closed from December 24, 2010 to January 2, 2011, including the furlough period of December 28-30. The Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC) will not meet during the closure period. Any emailed submissions, responses to reviews, inquiries, etc., that are received during the closure will be triaged for action when the University reopens on January 3, 2010.

Institutional Animal Care and Use Committee (IACUC)
The IACUC office will be closed from December 24, 2010 to January 2, 2011, including the furlough period of December 28-30. Any emailed submissions, responses to reviews, inquiries, etc., that are received during the closure will be triaged for action when the University reopens on January 3, 2010.

To access the UFRA system, link to http://apps.research.umn.edu/ufra/ and sign in with your internet x500 and password.  A job aid for UFRA can be found on the SPA website.

Submitted by Frances Spalding