Recently, we have received many communications regarding COVID-19 and the precautions we are taking as an institution. The health and safety of our staff and our research participants is of the utmost importance to us and our practices are consistent with the clinical guidelines that have been put in place to date.
The CTSO/CTSU’s (consistent with our partners) will remain open and conduct business consistent with the most current guidance from the institution. We will handle immediate issues that arise on a case-by-case basis and follow the aligned prevailing guidance from the institution.
In recognition of the benefits of social distancing in slowing the potential spread of COVID-19, CTSU staff are being encouraged to hold virtual meetings, where reasonable and practical, and we appreciate study teams' support in this practice.
COVID-19 Research Prioritization:
Anna Lok, M.D., Assistant Dean for Clinical Research, is a member of the new U-M Office of Research (UMOR) COVID-19 Research Prioritization Committee. This committee has been created to review and prioritize new or modified research projects related to the study of COVID-19. Studies will be ranked as high, medium, and low priority. The committee does not approve or disapprove studies but classifies the urgency for IRB review.
U-M researchers that are interested in leading COVID-19 research projects should complete the COVID-related Research Prioritization Form.
Questions? Email email@example.com.
COVID-19 Clinical Research Workflow Form:
With additional requirements for starting COVID-19 research, Principal Investigators may not know where to begin. To provide an easy-to-navigate walkthrough, the CTSO has created an interactive workflow to guide you through this process depending on your research needs.
Research tracks include:
- Clinical Study Requiring Patient Samples
- Interventional Clinical Trial
- Data Study
Click here, to view the interactive workflow.
COVID-19 Clinical Trials:
Clinical Trials Support Office Leadership has determined that it is necessary to prioritize trials that have the greatest likelihood of providing benefit to patients or the scientific community and that are the most feasible to implement from a logistics standpoint. The COVID-19 Trials Feasibility Review Committee (TRIFREC) has been established to review and prioritize COVID-19 trials. COVID-19 trials have now been fast-tracked to open in as little as two weeks from receiving the protocol.
All COVID-19 trials must be submitted to the Research Prioritization Committee and will be assigned as a high priority. Once the review has been completed, PIs will receive a notification to:
TRIFREC is expected to be able to generate priority scores, priority level (High/Medium/Low), and decisions to Proceed/Not Proceed within 5 business days from the receipt of a complete application. Disclaimer: Approval from TRIFREC does not mean a trial can start enrolling; rather, trials with feasibility approval will receive high priority support for activation. Questions or concerns about the Feasibility Review may be directed to Debra Tanton (firstname.lastname@example.org) or Peter Higgins (email@example.com).
Support for COVID-19 trials is provided through collaboration across CTSUs and MCRU, with patient consent coordination by the ACCST CTSU, sample collection and processing by MCRU, and financial and portfolio management remaining within a study team’s current CTSU.
The Clinical Trials Support Office (CTSO), Michigan Clinical Research Unit (MCRU), and Central Biorepository (CBR) have created the Emphasis on COVID-19-Related Research Biorepository to collect, process, and archive biospecimens from both residual clinical samples and prospective participants with SARS-CoV2 infection. The coordinated effort allows us to centralize recruitment and sample collection efforts in order to minimize staff exposure, reduce burden on patients and their families, conserve PPE, and facilitate timely and equitable access to samples for researchers.
We are currently collecting plasma, serum, and whole cells (buffy coat) on a daily basis, and have thousands of residual serum and plasma samples from clinical blood draws. Click here to learn how to access samples. Samples are dependent on availability and sample types are evolving. We are currently working on processes to collect fresh samples (less than 4 hours post-collection) and convalescent samples. To view a current inventory of what is available, view the CBR Inventory (updated weekly) and DataDirect.
Temporary Restrictions on Human Subjects Research:
The university just released temporary restrictions on human subjects research in an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment for clinical care. Visit the UMOR FAQs link (https://research.umich.edu/covid-19) under Research Involving Human Subjects to learn the full details.
Due to COVID-19, the Clinical Trials Support Office has worked across business partners to ensure uninterrupted support to research study work conducted at University of Michigan. The following resources have been developed to support this work:
- Minimum Footprint: Emergency Protocol and Subject Management Duties during COVID-19: The OnCore Team would like to ensure ongoing research receives IT support, as needed, specifically in regard to subject management and the related billing compliance. In the event the usual study coordinator is not able to fulfill their duties, an alternate person (PI, non-study coordinator) may need to step in and perform the minimum footprint needed
- Changing Protocol Status to "On Hold" or "Suspended" due to COVID-19: If your study is affected by the COVID-19 virus and will need to change protocol status in OnCore, such as putting it On Hold or Suspending it, please submit a ServiceNow ticket.
- Using Subject Calendars (Marking missed subject visits)
- Guidance on Subject Status Changes, Lab Send-outs, and Deviations in OnCore
- Implications of Study Pauses for ClinicalTrials.gov Decision Tool
How to Get Help
- ServiceNow ticket is submitted to OnCore CTMS team for PI or non-study coordinator access needing limited study coordinator duties
- PREFERRED METHOD: ServiceNow - Submit a Ticket (level 2 login) - include, "OnCore" in the subject line
- ServiceNow phone #: 734-936-8000 (Option 2) - ask service desk include "OnCore" in the subject line
- For studies in the Oncology Clinical Trials Support Unit, please reach out to the Oncology CTSU at CTSU-Oncology-IT@med.umich.edu.
MCRU COVID-19 Updates:
MCRU continues to operate during normal business hours to support research not affected by the restrictions placed on human subjects research. We have extended our laboratory processing hours to 8:00 PM, Monday-Friday.
To avoid delays in study activation, please continue to follow standard processes and indicate you will be using MCRU services in your IRB application. Under section 42.8 make sure to upload a Time & Events Table which is used to create the proposed budget and will inform MCRU on which visits require MCRU services, specific MCRU procedures, anticipated time of visit, and the location. If necessary, Lynn Cohan, CTSO Accounts Lead, will reach out with additional questions.
As a reminder, please contact the MCRU-Support (MCRU-Support@med.umich.edu) for any COVID-19 studies requiring MCRU services.
MCRU Community Engagements Visits:
In an effort to reduce the potential spread of COVID-19, MCRU is indefinitely postponing visits that are occurring in participant’s homes within the community. Visits that affect treatment or safety monitoring should be discussed with MCRU on a case-by-case basis.
CTSU Study Coordinators Regarding Monitoring Visits:
All visits to Michigan Medicine facilities that are unrelated to the health care of an individual are indefinitely postponed until further notice. This policy applies to study monitoring visits. This guidance may continue to evolve with time, based on additional guidance from the university. We will notify you if it changes.
Resources for hosting remote visits via conference call: https://www.bluejeans.com/
- View the Resource Tab for video tutorials and training opportunities
- Utilize screen share, video conference, phone conference, etc.
Research Pharmacy has put together a helpful document containing Frequently Asked Questions related to COVID-19 and Research Pharmacy. Click here to view Research Pharmacy's guidelines on shipping investigational products to study participants and the new in-basket communication process.
For questions please contact:
Please check the CDC (https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html) and Michigan Medicine (http://www.med.umich.edu/i/ice/resources/coronavirus.html) websites regularly for updated information.