Required Training
Good Clinical Practice (GCP) Training*
*Trials that follow the International Council for Harmonization Good Clinical Practice (ICH-GCP) require the CITI GCP training. This does not include all trials, but enough for all trialists to be certified.
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. More information is available on the HRPP Education Resources website.
U-M also offers The Social and Behavioral Research Best Practices training specifically for those involved in social and behavioral clinical trials. 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. Please contact sbr-pilot@umich.edu or (734) 763-1748 if you have questions.
High Reliability Training
High reliability is a concept based around the definition of reliable as, “The probability that a system, structure, component, process, or person will successfully provide the intended function(s).” Research shows that highly reliable organizations depend on transparency, and rely on their employees to raise concerns in order to make improvements. Highly reliable organizations reduce the risk of patient harm because they have reliable processes, make continuous efforts to improve, and have a robust culture of safety.
All faculty and staff must complete the Universal Skills Modules in Cornerstone Learning. The course SAFE-90239 should appear in your “Assigned Training” but if not, you can search for it using the search bar. For questions, email HRO-training@med.umich.edu.
HIPAA Training for UM Researchers
Michigan Medicine requires a web-based HIPAA training module for the entire workforce, including faculty, staff, students, volunteers, contract employees and others.
To enter a module in Cornerstone Learning:
- Log in to the portal through https://michmed.csod.com/samldefault.aspx
- Click the magnifying glass to search
- Enter “priv” (the beginning of the ‘code’ for the HIPAA modules) or HIPAA
Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS)
All human research at UM requires Human Subject Protections (HSP) training through the Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS). An updated Responsible Conduct of Research and Scholarship (RCRS) course, which is part of PEERRS and is designed to meet federal and institutional requirements, must be completed by June 30, 2021. This requirement applies to all U-M employees and students engaged in any facet of research and scholarship, regardless of internal or external support. More information is available here.
The Responsible Conduct of Research and Scholarship (RCRS) course and Research Administration course are required for all individuals listed on a Proposal Approval Form (PAF) or Award (AWD) for sponsored funding in any investigator role.
Faculty Education
Ask the Expert
The Clinical Trials Support Office's "Ask the Expert" sessions allow faculty, study teams, and staff to drop in during the hour to ask questions about their individual study or workflow needs. While pre-registration is not required, you will be asked to complete the registration form to enter the Zoom room.
These sessions are designed for faculty to meet statisticians and experts from the IRB, Office of Research Compliance & Review, MICHR’s IND and IDE team, Investigational Drug Service, and more. Each 60-minute Zoom session will include a 5 to 10-minute overview of the research unit by each expert. The rest of the time is reserved for general discussion and answering questions. The goal of these sessions is to share information that helps you navigate the U-M research landscape and to provide a forum where you can ask questions that need answers now.
Upcoming Sessions
Regulatory and Operational Experts from IRBMED, MICHR Clinical Research Management Team, Office of Research Compliance & Review
When: October 30
Time: 12:00 PM - 1:00 PM
Click here to register.
Biostatistics Experts from SABER (Statistical Analysis of Biomedical and Education Research Group) and MICHR
When: October 31
Time: 12:00 PM - 1:00 PM
Click here to register.
Drug & Device Study Experts from the MICHR IND/IDE Investigator Assistance Program (MIAP) and the Michigan Medicine Investigational Drug Service (IDS)
When: November 1
Time: 12:00 PM - 1:00 PM
Click here to register.
Data Experts from MiChart for Research and the Data Office for Clinical and Translational Research
When: November 2
Time: 12:00 PM - 1:00 PM
Click here to register.
Clinical Trials Academy - Early Career
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.
Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT) - Early Career
The Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT) workshop series is designed for study team members who are ready for an intermediate level of training. Participants will learn critical clinical research skills through a group learning environment and hands-on skills practice. Visit the MICHR event page to see upcoming sessions.
Investigational New Drug and Investigational Device Exemption Training
This self-guided course offered through MICHR is designed to introduce faculty to regulatory responsibilities of sponsors and investigators of drug and device studies.
This course will:
- Walkthrough the regulatory responsibilities of sponsors and investigators
- Highlight the ways that MIAP can help with your IND or IDE application
- Provide important contact information and resources
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. Uniqname and level 1 password required.
CTMS Support & Training for PIs
The Clinical Trials Management Systems (CTMS) team provides support and training to the clinical research community.
Training requirements are based on the roles approved by your Portfolio Manager:
CLICK HERE to request an OnCore account.
CLICK HERE to request an eReg account.
Questions? Please submit a ticket to the CTMS team.
Orientation for Clinical Investigators
Orientation for Clinical Investigators provides faculty with an overview of information, resources, and tools necessary to comply with regulations related to clinical research and will help efficiently navigate the University’s research enterprise. This seminar is for faculty new to the institution or new to clinical research, and there is no charge to the participant or department for participation.
Upcoming Session
When: October 23
Time: 7:30 AM to 9:00 AM
Where: Hybrid Event - Zoom and Med Sci I, Rm 6311
Learn More
Past Sessions
Session One:
2021:
View recording
View presentation slides
2022:
View recording
Session Two:
2021:
View recording
View presentation slides
2022:
View recording
For questions, email CTSOgroup@umich.edu.
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
- An overview of virtual clinical research
- 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.
Responsible Conduct of Research for K Awardees (RCR4K)
Responsible Conduct of Research for K Awardees (RCR4K) is a seminar series offered through MICHR designed to guide participants in identifying and managing ethics and integrity issues. It offers structured exploration of common research ethics and integrity dilemmas, and regulations.
Staff Education
C3RG-Sponsored Seminar Series
The Frankel Cardiovascular Center Clinical Research Group (C3RG) is a group of research professionals formed in June 2009. C3RG provides monthly seminars regarding a wide range of clinical research topics to research staff and coordinators of the entire University. Each session is held on the second Tuesday of each month from 12:00 PM to 1:00 PM.
More information on the C3RG website. To view details on the upcoming session, click here.
Conducting and Obtaining Valid Informed Consent
This workshop outlines the process of obtaining valid informed consent and will give you the opportunity to demonstrate the necessary language and communication skills when interacting with potential study participants and their families. This session is not about writing the informed consent document or specific U-M IRB requirements. Attendees of the workshop should come prepared for active participation.
Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT)
The Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT) workshop series is designed for study team members who are ready for an intermediate level of training. Participants will learn critical clinical research skills through a group learning environment and hands-on skills practice. Visit the MICHR event page to see upcoming sessions.
CTMS Support & Training
The Clinical Trials Management Systems (CTMS) team provides support and training to the clinical research community.
Training requirements are based on the roles approved by your Portfolio Manager:
CLICK HERE to request an OnCore account.
CLICK HERE to request an eReg account.
Questions? Please submit a ticket to the CTMS team.
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:
Sign in to My LINC with a Level 1 password to access the training.
Resources
ClinicalTrials.gov
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
- Clinical Trial Registration Requirements and Decision Trees - View this page for an overview of the steps researchers must take to register their clinical trials on ClinicalTrials.gov.
- UMOR Research Ethics & Compliance - Clinical Trials Registration & Results Reporting - The webpage offers useful information on what U-M investigator-initiated clinical trials need to register, who must register clinical trials, and how to register and report results on ClinicalTrials.gov. The webpage also includes contact information for U-M offices that offer ClinicalTrials.gov support and resources.
- MICHR ClinicalTrials.gov Support - This service offered through the Michigan Institute for Clinical & Health Research (MICHR) supports the registration of clinical trials on the ClinicalTrials.gov website.
MiChart Research Resources
A knowledgebase and resource repository for clinical users of Michigan Medicine's electronic health record system, MiChart. The site contains MiChart tip sheets, reference documents, training videos, information regarding updates and upgrades to the system, and much more.
NIH Clinical Trials Resources
The National Institute of Health provides in-depth guidance for investigators and staff of clinical trials, including several protocol templates, NIH definition decision tree & FAQ, enrollment guidance, and more. Click here to view NIH Clinical Research Toolkit & Educational Materials.
Research Faculty Development Wizard
The Research Faculty Development Wizard is a resource for all faculty to easily access Michigan Medicine research-related resources based on their career stage and interest.
Research Pharmacy
The U-M Research Pharmacy is a service provided by the Department of Pharmacy Services and supported by Michigan Medicine, to assist investigators in the handling of drugs used in clinical research studies.
Taubman Library
The Taubman Library offers Research Guides on a wide variety of information focusing on health sciences.
- Data Management Guide - This site offers tips on managing data and creating a data management/sharing plan.
The Michigan Diabetes Research Center (MDRC)
The MDRC Recruitment Service facilitates the identification of potential subjects with diabetes for clinical studies/trials at the University of Michigan by using the MDRC Diabetes Research Registry, MiChart Recruitment Alerts, and the Blue Cross Network. The MDRC Diabetes Research Registry consists of over 7800 of Michigan Medicine’s ambulatory care clinics’ diabetes patients interested in participating in clinical research. For more information about the Michigan Diabetes Research Center and how to use their services contact diabetesresearchregistry@umich.edu.
U-M Nutrition Obesity Research Center (NORC)
The mission of UM Nutrition Obesity Research Center (NORC) is to identify improved methods for the prevention and treatment of obesity, supporting a continuum of care from primary, secondary, tertiary prevention.