Clinical Trials Support Office: Human Research Reactivation

UPDATE: Thursday, December 2, 2021

Study teams must adhere to all of the most up-to-date university policies outlined on the UMOR Research Re-engagement website. For questions, contact mm-clinical-research@umich.edu

Work from home: Given the numbers of COVID-19 cases in the hospital system and the community at large, we urge all team members to continue to work from home and refrain from coming to the main medical campus unless necessary. Read the most recent update here

Sponsor Visit Guidelines

Michigan Medicine strongly encourages virtual visits. If an in-person visit is preferred, visitors must adhere to the following guidelines:

  1. The current Michigan Medicine visitor policy
  2. U-M Health conference and meeting room capacity reflected in SchedulOn and door signs
  3. Employees and visitors must complete the Responsiblue symptom screening prior to, or upon entry to Michigan Medicine facilities
  4. Limit the number of attendees and group meetings to only those necessary
  5. Masks should be worn in all indoor Michigan Medicine facilities and on busses, as well as in crowded outdoor spaces, such as building entrances and bus stops. 
  6. Masks should be worn at all times when working with participants in human subjects research and in health care areas where patients may be present; eye protection should be worn during face-to-face interactions with human subjects
  7. Continue to follow U-M policy of safe practice, including, but not limited to, hand sanitizing and disinfection of common equipment after use
  8. If you or a visitor feels sick, stay home and away from others. Seek medical attention, as necessary

To view Michigan Medicine's full guidance for study teams with sponsors performing site initiation, study monitoring, auditing, or close‐out visits for a clinical research study, click here.

Study teams can download the Michigan Medicine Site Visit Letter to inform Research Sponsors, CROs, and Study Monitors of Michigan Medicine's implementation of virtual site visits and remote study monitoring options for clinical research. 

COVID-19 Research

Getting Started
All COVID-19 treatment trials require submission of a CTSU Intake Form. CTSU will facilitate submission of the trial for review by a CTSU Feasibility Committee focused on COVID-19 research to determine scientific merit and feasibility including competition with ongoing COVID trials. Approval from this Committee is necessary for IRB submission. Questions, contact ctsogroup@umich.edu for outpatient trials and Barb Sullins at bmunsey@med.umich.edu for inpatient trials. 

Trial Management
Support for COVID-19 trials is provided through collaboration across CTSUs and the Michigan Clinical Research Unit (MCRU). For inpatient trials, support for patient consent is coordinated by the ACCST CTSU, sample collection and processing by MCRU, and financial and portfolio management remaining within a study team’s current CTSU.

COVID-19 Biospecimens
The COVID-19-Related Research Biorepository, managed by the Central Biorepository (CBR), collects, processes, and archives biospecimens from both residual clinical samples and prospective participants with SARS-CoV2 infection. To learn more, visit the CBR COVID-19 Biospecimens page.

Researchers who wish to access samples that are not in the Biorepository will need to submit an IRB application and are advised to contact your CTSU Portfolio Manager to discuss logistics of consent, sample collection, and processing to minimize competition among studies and interactions between COVID+ patients and staff.

CRAO Guidance for COVID-19 Testing

For studies that require COVID-19 testing, this activity will be represented on the OnCore Billing Grid in accordance with the Calendar Review & Analysis Office’s (CRAO) standard guidance that the specification should mirror the protocol. To address charge routing for COVID-19 testing activity that is not represented on an OnCore Billing Grid, submit an Unscheduled Occurrence in the MiChart In Basket.

Michigan Clinical Research Unit (MCRU)

MCRU continues to operate during normal business hours to support research approved for reactivation. Prior to all patient visits, study teams are required to call and pre-screen their patients to review for COVID symptoms within 72 hours of their visit to MCRU. 

As a reminder, please contact the MCRU-Support (MCRU-Support@med.umich.edu) for any COVID-19 studies requiring MCRU services.

 

Questions?

Contact us at MM-Clinical-Research@umich.edu

MBNI Building, 205 Zina Pitcher Place, Ann Arbor, MI 48105

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