*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 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 [email protected] or (734) 763-1748 if you have questions.

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” plan but if not, you can search for it using the search bar. For questions, email [email protected].  

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:

1. Log in to the portal through https://michmed.csod.com/samldefault.aspx
2. Click the magnifying glass to search
3. Enter “priv” (the beginning of the ‘code’ for the HIPAA modules) or HIPAA

All human research at U-M 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(link is external).

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.

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. 

Visit the CTSO event page to see upcoming sessions. 

Clinical Trials Academy: Protocol Development (CTA1) 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 and behavioral trials. 

The curriculum is designed to construct the most pertinent hypotheses, teach the fundamentals of clinical trial design, and develop scientifically rigorous and practical protocols for a broad landscape of clinical trials. Trainees will also receive practical tips for successful collaborations among investigators with complementary expertise across divisions and departments, and industry partners. CTA1 is free for trainees and departments. 
 

2025 Cohort Information

Duration: January 2025 - June 2025 
When: Afternoon on third Thursday of each month
Time Commitment: 2-3 hours of lectures, plus 2 hours of hands-on small group work with assigned faculty mentors and expert statisticians. 

Course Content:
Trainees in both tracks will attend lectures covering basic principles of clinical and behavioral trials together, and then break out for lectures specific to each track. Trainees are expected to work on their protocols throughout the entire duration of the academy, meet with their respective faculty mentors and statisticians between these sessions to enhance and solidify the training, and be able to complete their trial protocol by the end of the program. 

Attendance for all in-person and virtual sessions, small group meetings, as well as the timely completion of all homework assignments are mandatory for successful graduation.

To Apply:
Each application should contain the following: 

1. Letter of Support from the Division Chief/Department Chair/Associate Dean for Research outlining the candidate’s skills and qualifications. For faculty with clinical responsibilities, letters of support should also specify the division/department commitment to allow candidates to close clinical activities one afternoon a month for the duration of the academy and have enough additional time to finalize all homework and assignments as outlined above.
2. NIH Biosketch preferred. NSF Biosketch and Curriculum Vitae also acceptable. 
3. A clinical trial proposal including the main scientific question and its significance, and an outline of the study that they plan to work on during the program (No more than 5 pages including references) 
4. Please indicate your preference for which track you are applying to attend (drug and device trials or behavioral trials) and a brief rationale. Our team reserves the right to place you in the track that is considered most appropriate based on your proposed study. Note that content of both tracks, including reading materials and lecture slides, will be available to all trainees.

Applications can be submitted via email to [email protected] with the subject line 2025 CTA1: Protocol Development Application. 

Deadline to Apply: Friday, October 18, 2024

For questions, contact Johanna Carroll ([email protected]), Project Coordinator.

Clinical Trials Academy: Protocol Execution (CTA2) is designed to help investigators successfully and efficiently execute a well-designed protocol.

The course covers trial activities necessary to conduct a study with consistency and scientific rigor, from study start-up, to conduct, and close-out. Students learn to apply the concepts covered in lectures through hands-on exercises where an instructor will coach student investigators and their clinical research coordinators on developing essential trial tools, such as building a database, writing a manual of procedures, registering a trial in clinicaltrials.gov, preparing a trial budget, monitoring trial progress, and executing closeout activities. 

Qualifications
Qualified students will have completed Clinical Trials Academy: Protocol Development (CTA1), or have equivalent training or practical experience in designing or conducting investigator-initiated clinical trials. Ideally, students will have a protocol in hand, ready for the launch of an investigator-initiated clinical trial.

The 2024-2025 cohort begins November 2024. Application and course information for next year's cohort will be shared late summer/early fall. 

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.

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. 

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

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 presents materials to get started but does not replace PEERRS or other required training.

Offered in the fall, 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.

For questions, email [email protected]. 

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. 

For questions, email [email protected]. Visit the CTSO event page to see upcoming sessions. 

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. 

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. 

The Conducting and Obtaining Valid Informed Consent 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.

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. 

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.

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)
• Best Practices in Clinical Research (Online)

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