Workshop5: Data Safety Monitoring Board
May 11 2014 8:30AM - May 11 2014 5:30PM | Shanghai International Convention Center
No. 2727, Riverside Avenue
The DIA Data Safety Monitoring Board workshop will be led by Harvard Multi-Regional Clinical Trials Center and DIA. Faculty from Harvard, CFDA and representatives from industry will discuss various aspects of how clinical data can be monitored by an independent board – the DMC or DSMB. The format will be a workshop including lectures, discussion and case studies.
Who Should Attend
Registration is open to attendees from industry, academia and government. Clinicians, biostatisticians, principal investigators, study coordinators, project managers, regulatory o"cers, bioethicists, and research nurses with clinical trial experience are welcome.
- To gain understanding on what types of trial requires a DSMB to monitor safety
- To understand the roles and responsibilities of the DSMB members
- To understand the regulatory guidance pertaining to monitoring trials using a DSMB
- Gain knowledge on how trials may be stopped for futility or efficacy
- Understand how multi-regional clinical trials are monitored for safety