Clinical Trials Support Office
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.
What are some of the challenges faced by investigators conducting clinical trials?
Nationally, the clinical trials enterprise faces substantial challenges, in part, due to:
- 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
- Delays and logistical problems associated with a fragmented clinical trials infrastructure and healthcare system
Overall, the clinical trials and regulatory landscapes are ever-evolving. The CTSO and CTSUs are here to help investigators navigate the rapidly changing clinical trial environment.
Should trials that are conducted at the Veterans Affairs Hospital be included in a unit of the CTSO?
Trials are run at both Michigan Medicine and the Veteran Affairs Hospital should be included in a Clinical Trials Support Office CTSU. Trials that are 100% run at the VA should be left out due to different financial management systems.
Clinical Trials Support Units
What if faculty prefer to leave their trials outside of a CTSU?
All NIH-defined clinical trials and clinical research that requires a billing calendar are required to be supported by the CTSUs.
Does my project need a billing calendar?
A billing calendar exempt study meets the eResearch Study application guidelines for Section 14-1.1 and 14-1.2, in which no charges are generated that would be sent to the subject (patient), the subject's health plan, or research sponsor. In this situation, a billing calendar is not required for the IRBMED application. The CRAO team gives the final approval that a study is billing calendar exempt. If you are unsure, please reach out to your CTSU Portfolio Manager. They will work with you and CRAO to determine if a billing calendar is needed.
How do I get a billing calendar?
First, submit a CTSU Intake Form. Afterwhich, a Portfolio Manager will help facilitate the billing calendar creation with CRAO.
Are onsite monitoring visits allowed?
All visitors to Michigan Medicine must adhere to the current visitor policy regarding symptom screening and masking. Likewise, if Michigan Medicine restricts the number of visitors allowed, then the number of visitors for a study meeting must be restricted to the minimum necessary – with others attending remotely.
Can a faculty use more than one CTSU?
Yes, a faculty can use more than one CTSU if different trials have different research themes or unique needs.
What’s the funding source for the new support units?
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.
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 the expertise to provide support for data management and coordination, building eCRFs, etc. OnCore has the capability of managing multi-center trials.
How do we operationalize the cost as a researcher for CTSUs? How will the NIH's 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.
Clinical Trials Management Systems: OnCore and eReg
Where do I go for help?
- Start by using self-help resources available:
- CTMS training materials – videos available through Cornerstone Learning
- CTSO Work Guides – thorough step-by-step guides that assist study teams with their clinical research workflow
- Contact a CTMS Super User or speak with other users
- Contact your CTSU Portfolio Manager
- Contact the Clinical Trial Management Systems (CTMS) Team. Click here, to submit a Request for Help.
How do I get access to OnCore or eReg?
In order to receive access to OnCore or eReg, you must submit an account request form. Please see the Clinical Trial Management Systems Accounts & Support page to access the forms.
I understand OnCore has vast functionality, which OnCore resources are 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.
What systems integrate with OnCore, and which systems will phase out?
OnCore has several automated interfaces with Michigan Medicine's electronic health record, MiChart, reducing duplication of effort and possibility of data entry error. eResearch Regulatory Management will continue to be the source of truth for IRB information entry, which will integrate with OnCore. REDCap and Velos will remain available, though OnCore will be used to manage clinical trials' administrative data.
Is 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 clinical research that requires a billing calendar. PIs that want to use OnCore for clinical studies that are not clinical trials (such as registry or observational) should consult with the CTSO.