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.
Brought to you by the Michigan Institute for Clinical and Health Research (MICHR) and the Clinical Trial Support Office (CTSO).
- Understanding and Implementing a Protocol (May 3, 2017)
- Monitoring for Clinical Trials (May 11, 2017)
- Advanced Documentation for Clinical Trials (May 25, 2017)
REGISTRATION IS REQUIRED
Understanding and Implementing a Protocol
May 3, 2017 - 2:00 - 5:00 pm
This session will present best practices for interpreting and following a protocol for clinical trials research. Participants will learn how to utilize a protocol during a clinical trial and get tips for finding information quickly and efficiently within a protocol. Participants will also examine protocol examples to learn how to recognize frequently occurring problems and practice writing for clarity and feasibility.
Monitoring for Clinical Trials
May 11, 2017 - 2:00 - 5:00 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.
Advanced Documentation for Clinical Trials
May 25, 2017 - 2:00 - 5:00 pm
This session will introduce participants to best practices for creating, interpreting and using a manual of procedures (MOP) 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.
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Clinical and translational training has never been more exciting or accessible than it is today at the University of Michigan. The mission of MICHR's Education & Training programs is to provide engaging and effective multidisciplinary education, career development, and mentoring programs aimed at increasing the number of high-quality clinical and translational researchers across a broad career continuum.