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 for April and May:

Dates & Location:

Thursday, April 25, 2019 – MH B-1027
Tuesday, May 7, 2019 – MH B-1027
Thursday, May 23, 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

The Clinical Trials Support Office, in partnership with MICHR, is offering April, October, and December sessions of the Orientation for Clinical Investigators. The program is catered towards early-career faculty or experienced faculty new to clinical research at U-M but is open to all clinical research faculty. This 3.5 hr orientation provides participants with:

  • Information, resources, and tools necessary to navigate U-M’s research enterprise
  • A basic understanding of how to comply with regulations related to clinical research

Participants will learn about IRBMED, regulatory affairs, conflict of interest, audits and monitoring, ClinicalTrials.gov, clinical research finances, and U-M resources for clinical trials research – including the Clinical Trials Support Units. Contact ctsogroup@umich.edu with any questions.

2019 Date: TBD

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)

Have you completed basic instruction in clinical research but are looking for more? 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). 

Session Descriptions:

Procedures Documentation for Clinical Trials 
Wednesday, May 8 | 2:00 PM - 4:00 PM
This session will introduce participants to best practices for creating, interpreting and using a manual of procedures (MOP) and other procedures documentation to ensure standardized practices across personnel and sites of a clinical trial. Topics will include an overview of sections to include in a MOP, what to do if a documented procedure isn’t feasible and information about the new IRB requirement for uploading a MOP if you are coordinating a multi-site trial. 

Monitoring for Clinical Trials 
Wednesday, May 15 | 2:00 PM - 4:00 PM
This session will introduce participants to best practices in preparing for and participating in clinical trial monitoring visits. Topics will include understanding the purpose of monitoring and how it differs from an audit, what to expect from different types of monitoring visits, and tips on responding to follow-up letters and reports.

Are You Ready?: Big questions to ask before registering in ClinicalTrials.gov*
Wednesday, June 5 | 2:00 PM - 4:00 PM
This session will cover new requirements for registration, updates, use of special informed consent language, results reporting, and protocol uploads. Group exercises and discussion with regulatory and data sharing specialists will help participants learn how to avoid common mistakes in ClinicalTrials.gov and what preparations need to be made before registration. Big questions that will be addressed include:

  1. Is this a Clinical Trial?  Is it only one trial?
  2. What data will the PI be interested in sharing from this trial?
  3. What are the primary and secondary outcome measures?

*This session is only open to U-M employees or persons who are directly working on a clinical trial with a U-M principal investigator.

All sessions are held at BSRB in Room #2515.
Registration is Required. To register for any of these sessions, click here.

Our aim is to provide an outstanding experience for all attendees. If you require reasonable accommodations in order to attend, please find additional information on the registration page about how to request these.

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 (Online Course Coming Soon)
  • Conducting and Obtaining Valid Informed Consent 

Conducting and Obtaining Valid Informed Consent
This session outlines the process of obtaining valid informed consent and will give you the opportunity to demonstrate necessary language and communication skills when interacting with potential study participants and their families. Registration is required for this session and will open in late winter.

When: Thursday, April 4, 2019
Time: 2:00 PM -4:30 PM
Where: Danto Auditorium

To register, click here

The other sessions of Research Basics are moving online. You can currently find The Fundamentals of Data Management already at My LINC with a Level 1 password. Watch for an update soon on the second online module.

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 groups 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. 

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.