Training & Education

image of training in Danto Auditorium

 

The Clinical Trials Support Office provides a more structured and formalized path for developing study teams early in their career or new to clinical trial research. Here you will find details on training and education opportunities available to study teams.​

 

Training and Education Opportunities

OnCore Training

The OnCore Central Support Team provides support and training to help the clinical trials community transition to OnCore. Each OnCore training session provides hands-on training to allow staff and faculty practice with the functions they will frequently use.

OnCore Training requirements are based on the roles approved by your CTSU administrator. Please CLICK HERE to request an OnCore account.

Upcoming Training:

Thursday, October 24, 2019 – MH B-1027
Monday, October 28, 2019 – MH B-1027
Tuesday, November 5, 2019 – MH B-1027
Thursday, November 21, 2019 – MH B-1027
Tuesday, December 3, 2019 – MH B-1027
Thursday, December 19, 2019 –  MH B-1027

Schedule:

1:00PM – 4:00PM: OnCore Subject Management (CTMS-00303)

Click Here to Register in MLearning.

Access OnDemand OnCore Training Videos:
General Overview for Staff
Overview for Principal Investigators
Overview for Medical Directors
Continued Service Excellence Training for Study Coordinators

End-users who have successfully completed training can access a practice environment at the following link: https://oncoretraining.med.umich.edu.

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, ClinicalTrials.gov, and U-M resources for clinical trials research.

When: Spring 2020 TBD

If you require any special arrangements, please contact the Clinical Trials Support Office at CTSOgroup@umich.edu

Navigating the Clinical Trials Landscape

Are you interested in clinical trials research, but don’t know where to start? Are you eager to learn best practices from your colleagues? What were the hurdles faculty faced in adopting the new clinical trials support infrastructure and management system? What support and resources are now available?

Join faculty with trials supported by the Clinical Trials Support Office as they shine a spotlight on the clinical trials research transformation here at the University of Michigan. The seminar will be an engaging panel program featuring:

  • Peter Higgins, MD, PhD, Professor of Internal Medicine - Gastroenterology
  • Erica Marsh, MD, MSCI, FACOG, Associate Professor of Obstetrics and Gynecology - Reproductive Endocrinology and Infertility
  • Scott Hummel, MD, Associate Professor of Internal Medicine - Cardiology 

Seminar participants will leave with an understanding of how they, their teams, and their trials receive support in the harmonized processes that are now in place across the Medical School.

Objectives:

  • Learn best practices from junior and senior faculty for navigating the clinical trials enterprise
  • Illustrate the value-adds for faculty within the Clinical Trials Support Units and OnCore, U-M’s Clinical Trial Management System
  • Facilitate faculty partnership with Clinical Trials Support Units

Facilitators:

  • Steve Kunkel, Ph.D., Senior Associate Dean for Research
  • Anna Lok, M.D., Assistant Dean for Clinical Research
  • Teri Grieb, Ph.D., Senior Director for Research
  • Cyndi Bower, MS, Director of Clinical Trial Operations

Upcoming Sessions: 

TBD

If you are a person with a disability who requires an accommodation to attend this workshop or have questions about accessibility, please contact Jordan Wright (wjordan@med.umich.edu) or 734-764-2574. Please also let us know if you have any dietary restrictions or food allergies. Advance notice is necessary as some accommodations may require more time for the University to arrange so letting us know at least 2 weeks in advance is much appreciated.

Navigating Clinical Research: PI Responsibilities Module

MICHR, in partnership with the CTSO, has developed a short, choose-you-own-adventure online module as a follow up to the Orientation for Clinical Investigators. The module introduces the responsible conduct of research, defines important terms, and provides contact information and resources. The module presets materials to get started but does not replace PEERRS or other required training.

Click Here to Register in MLearning. Unique name and level 1 password required.

Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT)

The Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov (IMPACT) workshop series is designed for study team members who are ready for an intermediate level of training for clinical trials skills. Participants will learn critical clinical research skills through a group learning environment and hands-on skills practice. Maximum benefit will be gained by attending all three sessions, but it is not required. 

This series is brought to you by the Michigan Institute for Clinical & Health Research (MICHR) and the Clinical Trial Support Office (CTSO).

Procedures Documentation for Clinical Trials  - November 5
Monitoring for Clinical Trials - November 12

Are You Ready?: How ClinicalTrials.gov requirements are shaping study design and implementation - November 19

To learn more and to register, click here

 

Good Clinical Practice (GCP) Training

U-M provides basic good clinical practice (GCP) training for clinical trial study team members through the Collaborative Institutional Training Initiative (CITI). To access the CITI GCP course, you must first create a CITI account here and affiliate with the University of Michigan within CITI. View the CITI step-by-step instructions for details. More information is also available on the HRPP Education Resources website.

U-M also offers a course specifically for those involved in social and behavioral research. The three-hour course, offered by the Michigan Institute for Clinical & Health Research (MICHR), can be taken at a participant’s own pace. The course is designed to help learners apply GCP principles in an engaging course with relevant information and examples for social and behavioral research, as well job aids and best practices that participants will be able to implement in their everyday work. Topics covered include research protocol; recruitment and retention; informed consent communication; confidentiality and privacy; participant safety and AE reporting; quality control and assurance; and research misconduct. Following completion of the course, participants of the pilot study will be asked to complete two surveys. Information provided in the surveys will be used to improve the course. Please contact sbr-pilot@umich.edu or (734) 763-1748 if you have questions.

Register for the Course Here.

Research Basics for Study Teams

The Research Basics series is designed to present basic, introductory-level material covering concepts in clinical or health research. It is open to all study team members who are new to clinical or health research at U-M or new to any of the topics.

Sessions include:

  • Fundamentals of Data Management (Online)
  • Essential Documents and Good Clinical Practice 

Sign in to My LINC with a Level 1 password to access the training. 

Clinical Trials Academy

The Department of Internal Medicine’s Clinical Trials Academy offers early-career faculty and new clinician investigators a combination of lectures and hands-on small group sessions to teach the complex and changing landscape of clinical trials. The academy will teach practical tips to succeed including targeting cutting-edge basic research findings with relevant human disease, constructing the most pertinent hypotheses and questioning to catalyze innovation in drug/device discovery, teaching the fundamentals of clinical trial design, and understanding the changing landscape of clinical trials, from earlier phases to multicenter randomized and pragmatic population trials.

Click Here to Learn More. 

Working with Industry

Working with Industry is a workshop series for new and established faculty looking to learn more about the ins-and-outs of working on industry-sponsored clinical research studies.

Previously covered topics include:

  • What is the benefit to patients and one's career
  • How can investigators get noticed
  • The steps to get started - from receiving a protocol to opening a study
  • Which factors are important for determining study participation
  • How to negotiate a budget
  • Learning how to interpret monthly reports 
  • And more...

Presented through first-hand accounts from Industry Professionals, U-M Faculty, and Clinical Trials Support Office Staff, Faculty will gain a better understanding of the various aspects of industry-sponsored research and will learn strategies to ensure better results. 

Future Working with Industry sessions will resume in 2020.

Questions?

Contact us at CTSOgroup@umich.edu

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

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