This page details training and education opportunities available to U-M Principal Investigators and Study Teams:
- Orientation for Clinical Investigators
- Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT)
- Good Clinical Practice (GCP) Training
- Research Basics for Study Teams
Faculty Seminar: Bringing Added Value to Principal Investigators by Transforming the Clinical Trial Enterprise
Friday, Nov. 17, 11:00 AM to 12:30 PM, BSRB Seminar Rooms, first floor
The clinical trial landscape is evolving at a rapid pace and Michigan Medicine realized we needed to transform to continue as a research leader. The Clinical Trials Support Office is thus charged to create the new knowledge needed to improve clinical care, value, and health outcomes through clinical trial research. Collectively, this initiative is called the Clinical Trial Transformation. 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.
- Illustrate the value adds for faculty within the Clinical Trials Support Units and OnCore, U-M’s Clinical Trial Management System
- Define the PI role and responsibilities within the new Clinical Trials infrastructure
- Facilitate faculty partnership with Clinical Trials Support Units
- Inform faculty of NIH policy changes, provide guidance and support to comply with these and all policies.
Breakfast will be provided.
- Steve Kunkel, MD, Senior Associate Dean for Research
- Anna Lok, MD, Assistant Dean for Clinical Research
- Teri Grieb, PhD, Chief of Staff, Research Enterprise & Senior Director for Research
- Cyndi Bower, MS, Director for Clinical Trial Operations
On February 1, 2017, OnCore went live for all CTSUs excluding oncology. The CTMS Implementation Core Team will provide support and training to help the clinical trials community in the transition to this enterprise system. For more information about OnCore training, please visit or contact us at OnCore-Support@umich.edu.
After overwhelmingly positive feedback from the 2016 sessions, the Clinical Trial Support Office, in partnership with MICHR, are offering fall sessions of Orientation for Clinical Investigators. The program is catered towards early-career faculty or experienced faculty new to clinical research at U-M, though open to all clinical research faculty. This 3.5 hour orientation provides participants with:
- an orientation to information, resources, and tools necessary to navigate the University's research enterprise
- a basic understanding of what is needed 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. Please contact CTSOgroup@umich.edu with any questions about faculty orientation.
October 3, 2017, 8:00am - 11:30am, Kahn Auditorium, BSRB - **REGISTER HERE**
October 30, 2017, 7:30am - 11:00am, Seminar Rooms, BSRB - **REGISTER HERE**
(Attend only one session; No cost to participant or department)
Have you completed basic instruction in clinical research but are looking for more? The Instruction in Monitoring, Protocols and Advanced documentation in Clinical Trials (IMPACT) workshop series is designed for faculty, study coordinators with two or more years of experience and other study team members who are ready for an intermediate level of training for clinical research 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. All sessions are held at Danto Auditorium.
Procedures Documentation for Clinical Trials (November 6, 2017 - 2:00 - 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 (November 13, 2017 - 2:00 - 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.
ClinicalTrials.gov and Its Interaction with Protocols, Documents and Study Management (November 20, 2017 - 2:00 - 4:00 pm)
Before attending this session participants should have either used ClinicalTrials.gov or previously attended ClinicalTrials.gov registration training from the Office of Regulatory Affairs. This session will cover new requirements for registration, updates, use of special informed consent language, results reporting, and protocol uploads. Group exercises and discussion will help participants learn how to avoid common mistakes in ClinicalTrials.gov. Topics will include how to draft arms and interventions, translating protocol aims into specific outcome measures, and results reporting for different clinical trial models.
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 (free) and affiliate with the University of Michigan within CITI. See 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 email@example.com or 734.763.1748 if you have questions. Register for the course here.
The Research Basics workshop 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 listed below. This three-part series engages participants and provides opportunities for skill building and learning. Maximum benefit will be gained by attending all three sessions, but it is not required. All sessions are held at Danto Auditorium. Note: This is a hands-on skill-building training. If you register, please plan to attend and participate in the full 2.5 hours for each session.
• Fundamentals of Data Management (September 6, 2017)
• Essential Documents and Good Clinical Practice (September 20, 2017)
• Conducting and Obtaining Valid Informed Consent (September 26, 2017)
The Fundamentals of Data Management: Integrating Data Quality into the Clinical Research Process
September 6, 2017 - 2:00 - 4:30 pm
This course outlines basic data management concepts and the tools used by Data Managers to improve data quality. You will learn to speak the language of data management and discover how the concepts presented can be applied to the everyday management of research data. Topics include Case Report Form development, basic database design, and an overview of the processes used by data managers to reduce errors and identify unexpected or illogical results. No prior data management experience or technical background is necessary.
Essential Documents and Good Clinical Practice
September 20, 2017 - 2:00 - 4:30 pm
Topics in this session will help explain how GCP impacts the clinical research process and will examine root causes of non-compliance. We will explore actions to prevent research non-compliance, define source documents, list techniques for maintaining accurate source documents, and learn to recognize common errors.
Conducting and Obtaining Valid Informed Consent
September 26, 2017 - 2:00 - 4:30 pm
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.