Clinical Trials Support Units
Study Coordinator Support
Clinical Trials Management Systems: Accounts & Support
Training, Education & Resources
Michigan Clinical Research Unit
Michigan Medicine Site Profile
CTSO Frequently Asked Questions (FAQ)
Answers to the CTSO questions we hear most from faculty and staff.
The Clinical Trials Support Office and MICHR, in partnership with stakeholders and 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 include:
- An established clinical research pathway to support U-M faculty, especially early-career investigators, in developing a high-quality protocol.
- A clinical research operations manual that defines U-M standard procedures for activating and conducting clinical trials.
- Training for faculty and study coordinators.
- Implementation of the Clinical Research Coordinator career ladder to professionalize the study coordinator role.
- Streamlined regulatory review and contracting.
- Supporting an enterprise Clinical Trial Management System.
- Establishing and tracking key performance metrics that are publicly available to the UMMS research community.
- Oversight of the Michigan Clinical Research Unit
- MICHR continues to offer the following services to investigators: biostatistics, database development, data management, mentorship, recruitment planning, study monitoring, IND/IDE support, and education.
Nationally, the clinical trials enterprise faces substantial challenges, in part, due to the following:
- 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, clinical trials and regulatory landscapes are ever-evolving. The CTSO and CTSUs are here to help investigators navigate the rapidly changing clinical trial environment.
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.
All NIH-defined clinical trials and clinical research that requires a billing calendar are required to be supported by the CTSUs.
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 the CTSU Portfolio Managers. They will work with you and CRAO to determine if a billing calendar is needed.
First, submit a CTSU Intake Form. After which, a Portfolio Manager will help facilitate the billing calendar creation with CRAO.
Yes, a faculty can use more than one CTSU if different trials have different research themes or unique needs.
The importance of this initiative was 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) equally allocated funds to be used to make the recommendations of the Clinical Trials Task Force a reality.
After the initial investment, the Research Board of Directors (RBOD) determined the departments would assume financial responsibility for the CTSUs through a utilization model. The utilization model allocates the unrecovered CTSU budget to departments proportional to their faculty’s use of the CTSUs.
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. The Medical School Office of Research has partnered with the School of Public Health to expand service offerings, allowing investigators to tap into the expertise of the Statistical Analysis of Biomedical and Educational Research (SABER) Group to provide support for data management and coordination, building eCRFs, etc. OnCore has the capability of managing multi-center trials.
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.
- Start by using self-help resources available:
- Contact the Clinical Trial Management Systems (CTMS) Team. Click here, to submit a Request for Help.
In order to receive access to OnCore or eReg, you must submit an account request form. Please see the Clinical Trials Management Systems Accounts & Support page to access the respective form.
All NIH-defined clinical trials and clinical research that requires a billing grid are required to be entered in OnCore. Depending on the various attributes of the project, the footprint in OnCore and the required functionality will vary. Your CTSU portfolio manager will work with you to understand your project and determine the requirements to ensure compliance with the applicable policies.
OnCore has several automated interfaces with Michigan Medicine's electronic health record, MiChart, eResearch Regulatory Management, and eReg. REDCap and Velos remain available, though OnCore is used to manage clinical trials' administrative data.
Yes, if you have a project that does not meet the NIH definition of a clinical trial but would like to use OnCore, please reach out to the CTSO at [email protected]. We can discuss your project needs and determine if OnCore is the best solution.
O-CTSU: North Campus Research Complex, Building 300
2800 Plymouth Road
Ann Arbor, MI 48109
The Clinical Trials Support Office is a unit of the Medical School Office of Research, where our mission is to foster an environment of innovation and efficiency that serves the Michigan Medicine research community and supports biomedical science from insight to impact.