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).
There will only be one session of this IMPACT workshop this year, if you cannot make this date you can choose the ticket to me notified for future workshops.
REGISTRATION IS REQUIRED
Are you Ready? How ClinicalTrials.gov and Publisher Requirements Facilitate Transparency and Improve Science
November 16, 2022 - 2 - 4 p.m.
Session Description: ClinicalTrials.gov requirements and publisher expectations are changing the way studies are designed and implemented. Policies encouraging transparency and data sharing are affecting trial registration, updates, results reporting, and uploads of the protocol and informed consent. Group exercises and discussion with regulatory and data sharing specialists will help participants learn how to meet these requirements while strengthening scientific practices.
Primary audience: Investigators, senior study team members or anyone else involved in study design, grant writing, protocol development or any other aspect of planning Investigator-Initiated Studies that have not started enrolling. But anyone with a basic knowledge of 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.