A UNIT OF THE MEDICAL SCHOOL OFFICE OF RESEARCH


May 10, 2017 

Dear Colleagues,
2017 brought milestone accomplishments to the Clinical Trials Support Office (CTSO). The seven Clinical Trial Support Units (CTSUs) are currently supporting pre- and post-award services for new trials and a subset of existing trials, as well as study coordination for trials needing such service.
In total, 231 trials are now managed in the OnCore Clinical Trials Management System and the number increases daily. OnCore training is now offered every two weeks, as our OnCore Community grows.
The fourth session of our "Orientation for Clinical Investigators" program took place April 18. With an overwhelming 87% of attendees noting they would recommend the program to a colleague, the CTSO has started to plan fall Orientation sessions with our MICHR partners.
As we move through spring, we are grateful for the continued collaboration with our Study Teams, Departments, and OnCore Community as we execute a diverse portfolio of high-quality clinical trials.

Best regards,
Anna Lok, M.D.
Assistant Dean for Clinical Research
[email protected]

Latest clinical trial support activities:

profileIntroducing the Michigan Medicine Site Profile

The Clinical Trials Support Office has developed the Michigan Medicine Site Profile, providing sponsors an overview of U-M resources that are available to facilitate trial success.
click image to view the complete Profile

If you are contacted by an industry sponsor, your Clinical Trials Support Unit will assist in completing and returning the sponsor questionnaire. To increase U-M responsiveness and provide a more timely completion of site questionnaires, the CTSU will cite the Michigan Medicine Site Profile for general questions, allowing the study team to focus on the study-specific questions. This resource is brought to you as a result of direct input from clinical trial teams and university-wide business partners.

Questions about the Michigan Medicine Site Profile, or have suggested edits? Contact [email protected].

namechangeName Change on Study Documents - What You Need to Know About the Change to "Michigan Medicine"
The Clinical Trials Support Office has received questions regarding the recent name change of UMHS to "Michigan Medicine." This change should be reflected as follows on study documents:
  • Study documents for trials that are supported by the Clinical Trials Support Unit should use the U-M Medical School affiliation.
  • Clinical research supported by a clinical department (NOT the Clinical Trials Support Unit) should instead use Michigan Medicine. 
There is no need to re-consent or retroactively backtrack and edit documents because of the name change. Questions? Contact [email protected].

ctsuPreparing to Move Your Trial Into a Clinical Trial Support Unit
As we continue to transition trials into their appropriate Clinical Trial Support Units, we'd like to thank those who attended our Department Forum on April 13! CLICK HERE to view the Power Point presentation from that event.

Department staff whose trials have not yet migrated to a Clinical Trial Support Unit should keep the following in mind: 
  • Your CTSU will reach out to you
  • There will be the opportunity for discussion of process and questions
  • Your CTSU will go through a standard checklist with you
  • Your CTSU will confirm with the department when the transition is complete
How can you assist in the preparation?
  • Reconcile sponsor payments
  • Reconcile revenue
  • Reconcile subject visit activity
  • Complete SOA reconciliation through current month
  • Complete all necessary personnel changes
We understand that this transition may be challenging, and we encourage you to reach out to the appropriate CTSU. CLICK HERE to learn more about the CTSUs, and connect with the administrators for each.

counting231 Trials and Growing!
Our Clinical Trial Support Units went "live" in February with the OnCore Clinical Trials Management System, when a number of new trials and a limited number of existing trials transitioned to management within OnCore. There are now currently 231 trials in OnCore, and the number continues to increase! OnCore training is offered every two weeks, as our OnCore community grows. See below for the upcoming training events.
 
An OnCore Application Support Team has been formed to support the tool, comprising members from the Clinical Trials Support Office, H.I.T.S., and MICHR. If you have questions, you can contact the OnCore Application Support Team by submitting a ticket with H.I.T.S., either call 734-936-8000 (select option #2), or email [email protected] with "OnCore" in the subject line.

Additionally, OnCore users currently receive a weekly "Tips & Tricks" email newsletter. If you would like to be added to that
newsletter email list, contact us at [email protected].

The Clinical Trials Support Office is grateful for our study team colleagues as well as our partners in the Calendar Review & Analysis Office, H.I.T.S., MiCHART, and MICHR, who all contributed immense time and collegiality to the OnCore "go live."  If you are a member of one of those teams, thank you!   
 

eventsUpcoming Training & Events
  

Monitoring for Clinical Trials
May 11 * 2:00PM-5:00PM * Danto Auditorium, CVC
Register today! If this event shows "sold out," please sign up for the "IMPACT Wait List." Space is typically available, wait-listed attendees will be notified by MICHR.

OnCore Protocol Administration
May 17 * 8:30AM-10:00AM * Room 371, NCRC Bldg. 300
OnCore Protocol Maintenance
May 17 * 10:30AM-12:00PM * Room 371, NCRC Bldg. 300
OnCore Pre-Award
May 17 * 1:00PM-2:00PM * Room 371, NCRC Bldg. 300

OnCore Post-Award
May 17 * 3:00PM-5:00PM * Room 371, NCRC Bldg. 300
OnCore Subject Lifecycle Management
May 18 * 10:30AM-12:00PM * Room 371, NCRC Bldg. 300
OnCore Subject Visit Management
May 18 * 1:00PM-2:30PM * Room 371, NCRC Bldg. 300
Advanced Documentation for Clinical Trials
May 25 * 2:00PM-5:00PM * Danto Auditorium, CVC
Register today!  If this event shows "sold out," please sign up for the "IMPACT Wait List." Space is typically available, wait-listed attendees will be notified by MICHR. 

Questions? Or do you wish to add an event to the schedule that is relevant to the clinical trial research community at the U-M? Contact us at [email protected].

spotlightClinical Trials Spotlight
Michigan Medicine launches study of life-saving resuscitation treatment for sudden cardiac arrest

Even when rapidly treated, less than 10 percent of sudden cardiac arrest victims survive, according to the American Heart Association. That's why Michigan Medicine is launching a new study to examine the potential benefit of a life-saving resuscitation strategy for sudden cardiac arrest.

The Acute, Critical Care, Surgery & Transplant CTSU is managing the study "Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest," which is examining the feasibility and potential benefit of early transport of out-of-hospital cardiac arrest patients with ongoing CPR to an ECPR-capable emergency department. It will be conducted locally in partnership with the Ann Arbor Fire Department, Huron Valley Ambulance, and the Michigan Center for Integrative Research in Critical Care.  Read more >>  

For more information about the Clinical Trials Support Office, CLICK HERE.
Our mission in the Clinical Trials Support Office is to support faculty and staff at the University of Michigan Medical School as they work to create the new knowledge needed to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials.