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 interactive skills practice. Sessions will be virtual and information will be emailed to registrants before the event. Note: all sessions will have separate registrations so you can choose which sessions to attend.
Brought to you by the Michigan Institute for Clinical & Health Research (MICHR) and the Clinical Trial Support Office (CTSO).
Avoiding Pitfalls in ClinicalTrials.gov Registration
- Part 1: Outcome Measures - Why Plain Language Matters in the Age of Transparency
Tuesday, November 14 - 2-3 p.m.
- Part 2: Individual Participant Data Sharing Plans: What, Why, and How to Write One
Thursday, November 16 - 2-3 p.m.
ClinicalTrials.gov requirements and publisher expectations are changing the way studies are designed and publicized. Policies encouraging transparency, and data sharing are affecting trial registration, updates, results reporting, and informed consent. Even if you have assistance with your ClinicalTrials.gov registration, you will save time and energy from grant application through the registration process if you understand ClinicalTrials.gov terminology and data sharing expectations.
Presentations, group exercises and discussions 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 at University of Michigan or affiliated organizations, 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.
**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.