Join IRBMED for its Spring installment of its Seminar Series
on May 4, 2021:
A Comprehensive Look at Monitoring and Auditing of Human Participant Research
This seminar will provide a comprehensive overview of monitoring and auditing of human participant research. Topics to be presented will include identifying when a Data and Safety Monitoring Plan (DSMP) and/or a Data and Safety Monitoring Board (DSMB) is required and requirements for submitting DSMB reports, other monitoring reports and audit results to the IRB. A representative from the Office of Regulatory Affairs will present on FDA inspections as a form of audit and a representative from MICHR's Research Management team will discuss monitoring requirements, available monitoring services, and monitoring examples.