Read the CTSO Newsletter online: View as Webpage
July 2019
Clinical Trials Community
Anna Lok, M.D. Named Distinguished University Professor
Anna Lok, M.D., Assistant Dean for Clinical Research, along with five other faculty members, has received one of the University of Michigan's top honors as Distinguished University Professor.

Distinguished University Professorships, established in 1947, recognize senior faculty with exceptional scholarly or creative achievements, national and international reputations for academic excellence, and superior records of teaching, mentoring, and service.

The Board of Regents approved the appointments on July 18 and are effective September 1.

Join us in congratulating Dr. Lok in receiving this wonderful honor!
Update! Oncology CTSU OnCore Migration
As August approaches, the OnCore Clinical Trials Management System (CTMS) implementation continues with the migration of Oncology CTSU industry trials. This is the first large wave of Oncology CTSU trials that will exercise new workflows to improve research patient billing and allow for future success with a more integrated institutional platform. 

Notable changes: 

  • Investigators and study teams will start receiving more notifications from the OnCore system after the August migration

  • Study teams will be more engaged tracking patient activity in the OnCore CTMS and associating upcoming scheduled visits with subject timelines in MiChart as part of the new billing workflow
MiChart Upgrade Planned for October 20
The next MiChart upgrade is planned for Sunday, October 20. This will be the second planned upgrade for 2019 with a goal to reduce downtime duration and impact to the organization.
The October upgrade will include updates, system maintenance, and new features to the MiChart application. The most notable enhancement that will touch every MiChart user is the Storyboard, a redesigned workspace for users that replaces the Patient Header and provides quicker access to key details and common actions without switching screens. Storyboard will be a unifying feature across MiChart modules and users, telling the patient’s story in a consistent way, while also specializing the tools and information presented to the user for their role.
Principal Investigators
Drop-in Workshop: Michigan Research Experts Profile
Is YOUR profile up-to-date? Michigan Research Experts faculty profiles are auto-populated by various electronic records, but it’s also easy to customize your listing. Attend this drop-in editing workshop on Monday, August 19 to learn how to curate your profile, and have your questions answered by the Michigan Research Experts help team. 
New IRBMED Workflows for Research Assigned to Full Board or Expedited Review
On July 1, the IRBMED office modified workflows associated with applications submitted and assigned to the A1, A2, B1, and B2 regulatory teams/boards. With the goal of improving review efficiency and turnaround times, submissions to IRBMED will be assigned to regulatory staff dedicated to either expedited or full board workflows; the previous structure utilized a combined model. No changes are being made to the departmental assignments associated with full board reviews or other aspects of workflows. 

Details will be provided in August about the second phase of this effort focused on the C1 oncology board; a new C2 board will be added in early September. Please contact IRBMED if you have questions about any of these changes.
Register Today! Orientation for Clinical Investigators
Orientation for Clinical Investigators is designed for early-career faculty or experienced researchers new to clinical research at U-M. This 3.5-hour session will provide participants with: 

  • Orientation to information, resources, and tools necessary to navigate the university's research enterprise.
  • Basic understanding of what is needed to comply with regulations related to clinical research.

Participants will learn information about IRBMED, regulatory affairs, conflict of interest, audits and monitoring,, and
U-M resources for clinical trials research.
Study Teams
Join Us! ABS Network Lecture Series
Join us on September 12, from 3:00 PM to 4:00 PM, at Danto Auditorium for Clinical Trial Data Monitoring Committees: The Basics and Some Controversies presented by Dr. Susan Ellenberg, Ph.D., Professor of Biostatistics, Perelman Medical School, University of Pennsylvania.

Dr. Ellenberg will discuss the role of data monitoring committees, also called Data and Safety Monitoring Boards (DSMBs), in the clinical trial oversight process. She will address the various controversies of DMC (DSMB) operations and the issues of which trials actually need the oversight of an independent DMC.
Space is limited.
New Research Basics Module Available
Research Basics: Best Practices for Clinical Research is now available on My Linc with a Level 1 password. This self-guided course is designed to outline best practices for clinical research. While these best practices are based in the principles of Good Clinical Practice (GCP) from the International Conference on Harmonization, this course is not able to fulfill requirements to complete GCP training and does not replace any other required training such as PEERRS. You will gain a broad overview of human subjects research and learn best practices that can be adapted to any type of research.
Apply for The Working Group
Are you a member of a study team (faculty or staff) who does research on health or medicine? Do you work for an office that provides support to researchers across different departments?
If so, consider applying to serve on the Study Team Workforce Development Working Group (The Working Group) to share your knowledge, experience, and skills related to study team training and education at the University of Michigan. The group is organized by the Michigan Institute for Clinical & Health Research (MICHR).
The deadline to apply is September 10.
Training & Events
Friday, August 2
12:00 PM - 1:00 PM
Waggoner, MBNI
Thursday, August 6
1:00 PM - 4:00 PM
Michigan House - B-1027
Thursday, August 22
1:00 PM - 4:00 PM
Michigan House - B-1027
Wednesday, Sept 25
12:00 PM - 1:30 PM
NCRC Building 10,
Research Auditorium
Clinical Trials Spotlight
New Study Aims to Reduce Cannabis Use in Young Adults Through Social Media
The Behavior, Function, and Pain CTSU is currently supporting a behavioral study run entirely online and led by Principal Investigator, Erin Bonar, Ph.D. from the Addiction Center within the Department of Psychiatry. This study aims to reduce cannabis use in young adults aged 18 to 25. 

Individuals in their late teens and early 20s have the highest prevalence of cannabis use with approximately 1 in 5 reporting use in the past month and about 1 in 16 reporting daily consumption. Some studies have shown that early cannabis use may affect neuro-maturational changes to the developing brain, resulting in lasting emotional and cognitive consequences. 

By developing and testing a social media based intervention focused on harm reduction, this pilot study hopes to reduce cannabis use in emerging adults. The social media based intervention aims to capitalize on the role of peer influence and mentoring in this population using slightly older peer health coaches in a medium constantly accessed by emerging adults in their day to day lives.  

“We recognize that young people don’t usually seek out prevention, so our team focuses on reaching them where they already are: social media," explained Erin. “We also know that they don’t want to be lectured to, so we seek to engage and support them in finding ways to meet their personal goals, while exploring the impact cannabis can have.” 

Due to the sensitive nature of this study, there have been several layers of security practices put in place to maximize the privacy among and for participants. More information regarding this study will be released as it progresses. 

This study also involves a team of faculty from U-M including Dr. Maureen Walton from the Department of Psychiatry and Dr. Jason Goldstick from the Department of Emergency Medicine and U-M Injury Prevention Center, with consultants from University of Pennsylvania and UCLA. 
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.
To better navigate the complexities of the U-M biomedical research enterprise, visit the Research Project Lifecycle . This interactive tool provides an overview of the resources available to you, not only within the Medical School Office of Research but also across the University of Michigan.