Clinical Trials Support Office: COVID-19

COVID-19 Clinical Trials:

Getting Started:

All COVID-19 trials must be submitted to the Research Prioritization Committee and will be assigned as a high priority. The committee reviews and prioritizes new or modified research projects related to the study of COVID-19. The committee does not approve or disapprove studies but classifies the urgency for IRB review. Once the review has been completed, PIs will receive a notification to submit a CTSU Intake Form.

Trial Management:

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.

Questions? Email research.covid19@umich.edu

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 Biorepository:

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

 

Questions?

Contact us at CTSOgroup@umich.edu

The Molecular & Behavioral Neuroscience Institute, 205 Zina Pitcher Place, Ann Arbor, MI 48105

A list of CTSO-CTSU contacts are available in the Personnel Directory.