Program Overview:
Have you completed basic instruction in clinical research but are looking for more? The Instruction in Monitoring, Procedures Documentation, and ClinicalTrials.gov (IMPACT) workshop series is designed for study team members who are ready for an intermediate level of training for clinical trials skills. Participants will learn critical clinical research skills through a group learning environment and hands-on skills practice. Sessions will be virtual and information will be emailed to registrants before the event. Note all sessions will have separate registrations.
Brought to you by the Michigan Institute for Clinical & Health Research (MICHR) and the Clinical Trial Support Office (CTSO).
REGISTRATION IS REQUIRED
*In 2022, we will only be holding this workshop in July and will not have a fall session. If you are interested in the training and cannot make the July 20 workshop, please sign up to be notified about future workshops.
Session Description:
Monitoring for Clinical Trials
Wednesday, July 20, 2022 - 11:00 am - 1:00 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.
The primary audience for this session is study team members who are involved with required monitoring visits for drug, device or biologic clinical trials but anyone interested in learning more about monitoring for clinical trials is welcome.
Due to confidentiality and U-M specific policies and procedures this session is only open to U-M employees, employees of officially affiliated health systems such as U-M Health West or Mid-Michigan, or persons who are directly working on a clinical trial with a U-M principal investigator.
**Our aim is to provide an outstanding experience for all attendees. If you require reasonable accommodations in order to attend, please contact the organizers two weeks prior to the event at michr.umich@gmail.com