Full course description
LIVE SESSION: Wednesday, November 17, 2021 @10:00am - 11:00am, Zoom
REd Synchronous classes are taught by subject matter experts, and provide both fundamental and advanced skills training in flipped classroom format. These classes are offered live (currently, via Zoom), wherein participants will attend and participate in the 1-hour live lecture/presentation. Participants will be required to work pre-class and post-class activities outside the classroom. These activities can include: readings, videos, etc.
Class Description: Data Monitoring plans are required for all human subject research projects at the University of Utah while Safety Monitoring plans are required for all greater than minimal risk human subject research. Studies that do not have an industry sponsor often require the investigator to create the data and safety monitoring plans. Additionally, if an industry sponsor does not provide a local data monitoring plan, the investigator must create one. These plans are required as part of the IRB approval process.
Objectives: At the conclusion of this class, you should be able to:
- Describe the differences between and components of data monitoring and safety monitoring
- Determine the need for a data and safety monitoring plan, board, or committee
- Demonstrate how to complete IRB application Data Monitoring and Safety Monitoring pages
Class Duration: Total duration for synchronous classes are approximately 2 hours. Those two (2) hours will be broken down into:
- A live session which will take approximately 1 hour (45-minute presentation and 15-minute Q&A) and;
- Pre and Post-work activities which will take approximately 1 hour, in total.