This FAQ offers answers to questions regarding
- Clinical Trials Support Units (CTSUs)
- OnCore Clinical Trials Management System (CTMS)
- Background on the Clinical Trials Transformation & Clinical Trials Support Office CTSO
If you have questions that are not answered below, please contact CTSOgroup@umich.edu.
Clinical Trials Support Unit (CTSU) Questions
What are Clinical Trials Support Units (formally called "nodes")?
Clinical Trials Support Units are business units that partner with investigators and their teams to ensure the timely and efficient activation and execution of clinical trials at UMHS. A faculty Medical Director(s) experienced in conducting clinical trials leads each support unit with assistance from a senior administrator. Support units vary in size but provide services, such as cohort identification assistance, budget development and negotiation, feasibility assessment, billing calendar creation and coverage analysis, MiChart build coordination, regulatory submission support, contracting support, site initiation support, study coordinator coordination, financial management and invoicing, ClinicalTrials.gov registration and reporting, FDA audit support, and study close-out support. Ultimately, the support units will operate using a standard operations manual to harmonize elements across the clinical trial enterprise, while allowing for local flexibility to reflect the uniqueness of various types of trials. Given that support units are trans-departmental, each support unit will establish an Advisory Board that is comprised of the department chairs, or the chairs’ designees, from every department that uses the Support Units services. This structure ensures that departments have input and influence over the services being offered and the quality of the services. The 7 CTSUs are:
When should studies move into the CTSUs?
All clinical trials conducted by UMMS faculty will be required to use the CTSU infrastructure by January 2018 with migration of existing trials beginning in 2017. The pilot CTSUs (Acute, Critical Care, Surgery & Transplant; Children’s; Heart, Vessel, Blood; and Oncology are now open for business. All new clinical trials with science that fits into one the pilot CTSUs are required to utilize pre- and post-award services in the respective CTSU now. Existing clinical trials that will be ongoing past January 2018 will be migrated into the CTSUs. Three additional CTSUs (Ambulatory & Chronic Disease; Behavior, Function & Pain; Neurosciences & Sensory) will be open for business in January 2017.
Can a faculty join more than 1 CTSU?
Yes, a faculty can join more than 1 CTSU if different trials have different research themes or unique needs.
How do the CTSUs benefit study teams?
The objective of the RBOD is to ensure that a common, high value infrastructure is available to all trained faculty irrespective of their home department. The support unit is a “one-stop shop.” Having CTSU staff dedicated to and expert in clinical trial activity provides continuity during study team turnover, retains highly competent study personnel during periods of reduced PI funding, and cushions faculty from carrying full personnel expenses when they only need fractional support. The new CTSU model provides a more structured and formalized path for developing investigators early in their career or new to clinical trial research. Similarly, study coordinators have a defined path for professional and career development. With stronger institutional support for clinical trials, UMMS will be able to retain and recruit clinical scientists and improve our national visibility. We aim for faculty and study personnel to experience easier navigation through the process, stronger support, and increased satisfaction.
What’s the funding source for the new support units, as well as other Fast Forward Clinical Trials activities?
The importance of this initiative is underscored by a commitment of up to $30M to ensure we have the capacity, infrastructure, and capabilities to improve our performance in this area. Dean Runge and the U-M Medical Group Practice (formerly Faculty Group Practice) have equally allocated funds to be used to make the recommendations of the Clinical Trials Task Force a reality.
Pre- and Post-award teams will be absorbed into CTSU?
30% of clinical research at UM is clinical trial research, meaning 70% of research will remain within the department. Similar to the study coordinator role, the research is not going away so pre- and post-award teams are still in demand. Many of the CTSUs are hiring or will be hiring these positions and look to hire from the experts from within the departments at UM. If a non-trial clinical study does not choose to integrate with a CTSU, it can remain in the department and continue to use the departments' finance staff. Sometimes the departments don't have the expertise, so we are going across units to establish such expertise. The CTSUs have strong partnerships with grants administrators, department administrators, and department staff.
How do study coordinators get absorbed or continue to work within their department?
Some coordinators may move from their department to a CTSU. Other PIs may choose to continue using their own coordinators. Some coordinators may also have a portion of the FTE connected to a CTSU. The amount of research is not decreasing at UM, so study coordinators, administrators, and pre- and post-award staff will be busy though some may move from a department to a CTSU.
Will the CTSUs be in competition with each other?
This initiative is focused on assisting investigators and facilitating efficient, quality clinical trials research. The CTSUs have standard processes and meet on a regular basis to facilitate collaboration. Each CTSU is designed to serve a specific constituent so the likelihood of competition is low.
Do CTSUs have the ability to support multi-center trials, including those which have international sites?
If our researcher is the PI coordinating the multicenter study, indeed, CTSUs will support those trials. The CTSUs have central teams to assist with a variety of aspects associated with a larger trial, such as complex calendar builds and regulatory compliance. MICHR and School of Public Health also have expertise to provide support for data management and coordination, building eCRFs, etc. OnCore has the capability of managing multi-center trials.
What if faculty do not want to move their trials into a CTSU?
Every faculty who intends to do trials past Jan 2018 will need to have their trials processed by a CTSU. We encourage faculty to review the services offered by the CTSUs and to join one that best fits their needs. In the near future, IRB submission will require indication of CTSU and if none is selected, the IRB will re-direct faculty into a CTSU. We expect faculty will continue to learn about and see the benefits of the CTSUs and OnCore as this initiative progresses.
How will the OnCore implementation affect study teams and clinical trial administrative staff?
All members involved in clinical trials management will directly or indirectly be involved with the implementation and benefit from the use of OnCore. This can include entry of study information, updating protocol amendments, overseeing budget and financial status or reports of generated from onCore.
Will all data from the UM legacy systems be migrated into OnCore?
Yes, trial data for existing active studies will migrate into OnCore in waves. The first wave of trials is currently being selected based on the CTSU the trial is associated with, trial enrollment, and the trial’s expected closing date.
Will the legacy systems still be accessible after go live?
Studies will remain in MBECT until they are migrated into OnCore. eResearch will continue to be the source of truth for IRB information entry, which will integrate with OnCore.
What type of training will be given for OnCore?
End user training sessions will cover functions of OnCore based on the specific access given to a particular role (coordinator, financial, etc.). Tools will be provided for follow up training and additional training sessions if necessary. Individual training will also be available as needed. Post implementation, OnCore Super Users and the OnCore Core Team will provide at-the-elbow support.
How does OnCore integrate with MiChart?
OnCore has several automated interfaces to the U-M Health System’s electronic health record, MiChart, reducing duplication of effort and possibility of data entry error. The MiChart team and OnCore Implementation team are working closely to finalize the integration elements for the upcoming OnCore deployment.
What is the risk that OnCore just becomes another system that we have to enter administrative data in?
OnCore will be the central source of information for managing protocol administrative data for all clinical trials and providing information about U-M’s overall trial portfolio. OnCore can also be used for research data, if the study teams so choose. Other universities that have adopted OnCore have found value in the system not only for administrative data but also for research data.
School of Public Health is a data coordinating center (DCC). How will that work with OnCore?
If the role of UM is only the DCC, meaning UM is not a clinical site, there is no need to go through the CTSU. If UM role is DCC and also clinical site – the clinical site portion must go through CTSU if this is a clinical trial. If it is not a clinical trial, per NIH definition, it does not need to go through a CTSU. The DCC portion can go through department grants office particularly if including different PIs.
OnCore sounds like the one stop for all clinical trials at U-M. Will OnCore be available to researchers' trials that do not meet the NIH definition of a clinical trial?
At this point, we are prioritizing clinical trials and establishing best practices. PIs that want to use OnCore for clinical studies that are not clinical trials (such as registry or observational) should consult with medical directors of the CTSU most relevant to their research.
I understand OnCore has vast functionality, which of OnCore’s resources will be required for CTSUs, study teams, and staff members to use?
Use of the following tools are required: billing calendar (budget), tracking study visits, patients enrolled, and finance. OnCore offers many other functions that are optional.
Will the University phase out REDCap because of the arrival of OnCore?
No, REDCap will remain available, though OnCore will be used to manage clinical trials' administrative data.
What is the Clinical Trials Transformation?
At the outset of the Strategic Research Initiative, "transforming" clinical trials activation and participant recruitment was identified as a key enabler requiring attention and investment. The Medical School’s Research Board of Directors (RBOD) formed a Clinical Trials Task Force, comprised of Department Chairs and Center Directors, to conduct discovery and make recommendations regarding system-wide process improvements for clinical trials research. The Clinical Trial Transformation is the execution phase of the recommendations made by the Task Force. The RBOD has tasked a Clinical Trials Subcommittee to work in partnership with the Medical School Office of Research with oversight of implementing the clinical trial task force recommendations. Main elements of Fast Forward Clinical Trials includes the Clinical Trials Support Office, 7 trans-departmental Clinical Trials Support Units (CTSUs) that are aligned with common areas of research, and the OnCore Clinical Trial Management System.
What are the primary functions of the Clinical Trials Support Office (CTSO)?
The CTSO provides central infrastructure, standards, and strategic oversight to the CTSUs.
What will happen with support staff currently involved in clinical trials?
The new model continues to require support staff; however some of the support staff such as study coordinators and finance staff that are currently department based may join a CTSU as their PIs and the trials they support move into CTSUs while others will retain their current positions and continue to support clinical studies that are not clinical trials. During the transition, some staff may have efforts within a CTSU and a department.
What functions/processes will be centralized at the Clinical Trials Support Office & MICHR rather than managed at the support unit level?
The Clinical Trials Support Office and MICHR, in partnership with the Clinical Trials Subcommittee and informed by members of the research community, continue to develop tools, common standards, and performance metrics to assess all aspects of the Clinical Trials Transformation. Centralized functions will include:
- Establishing a clinical trials pathway in MICHR to support U-M faculty, especially early-career investigators, in the development of a high-quality protocol.
- Developing a clinical trials operations manual that defines U-M standard procedures for activating and conducting clinical trials.
- Providing training for faculty and study coordinators.
- Implementing the professionalization of the study coordinator role.
- Streamlining regulatory review and contracting.
- Implementing and maintaining an enterprise Clinical Trial Management System.
- Facilitating the identification of potential trial participants, as well as enabling providers to easily find active trials.
- Furthering recognition of clinical trials activity in the promotion and tenure process.
- Integrating the clinical and research experience for patients.
- Establishing and tracking key performance metrics that are publicly available to the UMMS research community.
- MICHR will continue to offer the following services to investigators: biostatistics, database development, data management, mentorship, recruitment planning, study monitoring, IND/IDE support, education, and the Michigan Clinical Research Unit, among others.
Who are the Clinical Trials Subcommittee members?
Grant Comer, M.D. David Fink, M.D. Yolanda Helfich, M.D. Ed Hurvitz, M.D. Ray Hutchinson, M.D. Steven Kunkel, Ph.D. Theodore Lawrence, M.D., Ph.D. Anna Lok, M.D., (Chair) George Mashour, M.D., Ph.D. (Vice-Chair) Robert Neumar, M.D., Ph.D. David Pinsky, M.D. Vaibhav Sahai, M.D. Samuel Silver, M.D., Ph.D.
What are some of the challenges faced by investigators conducting clinical trials?
Nationally the clinical trials enterprise faces substantial challenges, in part, due to the increased complexity in research study design; regulatory complexity; inadequate funding mechanisms; globalization and outsourcing of trials to areas with lower research costs; lack of prestige allocated within the medical school setting to the conduct of clinical trials; and delays and logistical problems associated with a fragmented clinical trials infrastructure and health care system. Locally, there are added challenges faced by UMMS faculty conducting clinical trials. U-M support services for clinical trials are disjointed, with no one entity responsible and accountable for the overall process and performance. Many U-M units supporting the conduct of clinical trials have emerged out of regulatory requirements, not as service units focused on assisting faculty in the efficient and effective conduct of high-quality clinical trials. Overall, the clinical trials and regulatory landscapes are evolving rapidly and, today, our traditional support system is too fragmented, rigid, and slow, putting our faculty’s competitiveness in this area at risk.
Should trials that are conducted at the Veterans Affairs Hospital be included in the CTSU?
Trials are run at both the University of Michigan Health System and the Veteran Affairs Hospital should be included in the CTSU. Trials that are 100% run at the VA should be left out of the CTSU, as the finances are very different.
What will happen to existing clinical trial groups, such as the Cancer Center CTO and MICHR CTO?
- Cancer Center CTO is a required element of the NCI Cancer Center Core grant. As such, it will continue to exist as part of the Cancer Center as well as be the corner stone of the Oncology CTSU. The Oncology CTSU intends to provide full service support to all Medical School faculty conducting biomedical and behavioral interventional cancer trials.
- As part of the CTSA, the MICHR CTO (M-CTO) serves the entire U-M campus and research community. The M-CTO will continue to support investigators from other schools and colleges who don’t participate in the CTSU infrastructure.
How are we defining “clinical trials”?
According to the NIH definition, A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials are a subset of clinical research; therefore, the definition is not intended to be inclusive of all clinical research activity. Click here to review the NIH clinical trial decision tree, which facilitates the decision of whether the study is a clinical trial.
What is the goal for the clinical trials enterprise?
The RBOD-endorsed goal of Fast Forward Clinical Trials is to create the new knowledge needed to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. The six strategies to achieve this goal include:
- Foster a UMHS culture that values, rewards, and supports clinical trial activities.
- Develop a coordinated, sustainable infrastructure that supports operational excellence throughout the life cycle of clinical trials.
- Develop a highly trained, innovative, and skilled workforce, including those who initiate and those who conduct clinical trials.
- Translate U-M discoveries into clinical trials.
- Fully integrate the clinical trials enterprise and the clinical care delivery system.
- Demonstrate the value of clinical trials to patients, families, and society.
What are the performance metrics for Fast Forward Clinical Trials?
Performance metrics under consideration include:
- Satisfaction – investigator, study team, sponsor/lead site, participants
- Number of faculty served and % of early career investigators (or new to clinical trials)
- Study times – total initiation time, time to 1st enrolled, time to last enrolled
- Regulatory – volume, turnaround times, & quality
- Contracting – volume & turnaround times
- Feasibility review/prioritization – # of open trials, ratio of approved to turned down
- Accrual – rate, total numbers, ratio accrued to target
- Coordinator – volume, complexity, enrollment
- % of studies published
- Finances - study and CTSU financial performance
How do we operationalize the cost as a researcher as we layer the CTSU? How will the NIH's new per subject payment model affect me?
The per subject payment model is quite similar to the industry trial model and our CTSU infrastructure is well suited for this model. We do not expect it will cost you more money to use the CTSUs, in fact, we hope our budget training and justification will facilitate cost savings. Even with top researchers, money is left on the table, so a better system will facilitate tracking of payment and making sure invoices are issued in a timely manner.
It seems this transition to the CTSUs and OnCore is happening quite quickly; should the transition be more gradual, or do we expect the CTSUs to open all at once?
While it seems like a quick process to those outside the CTSO, the Fast Forward Clinical Trial initiative has been ongoing for the past four years to best establish the infrastructure to support faculty and clinical research. All new clinical trials will process through the CTSUs and thus OnCore beginning Jan. 2017 (note: The Oncology CTSU will migrate trials into OnCore during Q3 2017). Existing trials will migrate into CTSUs in 2-3 waves, which allows us to learn and adapt. The CTSU medical directors will be the first to have their trials migrated, along with any other interested principal investigators. Easing the transition, the CTSUs are actively seeking to hire internal UMHS administrators, finance staff, and study coordinators. There will also be central support to assist with the migration. The four pilot CTSUs (Acute, Critical Care, Surgery & Transplant; Children’s; Heart, Vessel, Blood; and Oncology) have been open for business since July 1, 2016. The three new CTSUs (Ambulatory & Chronic Disease; Behavior, Function, Pain; and Neurosciences & Sensory) will open Jan. 2017.
Have additional questions? Please contact the Clinical Trials Support Office at CTSOgroup@umich.edu.