This page details training and education opportunities available to U-M Principal Investigators and Study Teams:
- Orientation for Clinical Investigators
- Navigating Clinical Research: PI Responsibilities module
- Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials (IMPACT)
- Good Clinical Practice (GCP) Training
- Research Basics for Study Teams
On February 1, 2017, OnCore went live for all CTSUs excluding oncology. The OnCore Central Support Team provides 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 & 2017 sessions, the Clinical Trial Support Office, in partnership with MICHR, are offering April and October 2018 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.
When: April 23rd, 2018
Time: 1 p.m. – 4:30 p.m.
Where: 2901 Taubman Health Science Library
Register now for the April 23rd session.
MICHR, in partnership with the CTSO, developed a short, choose-your-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. Please note that the module presents materials to get started, but does not replace PEERRS or other required training. Register and access the module HERE. The module is available to anyone with a unique name & level 1 password.
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
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
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
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 firstname.lastname@example.org or 734.763.1748 if you have questions. Register for the course here.
The Research Basics workshop series presents 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.
- Fundamentals of Data Management (March 8)
- Essential Documents and Good Clinical Practice (March 15)
- Conducting and Obtaining Valid Informed Consent (April 2)
Time: 2 p.m. – 4:30 p.m.
Where: Danto Auditorium
Watch for more information and registration at the MICHR Events page.