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Workshop5: Data Safety Monitoring Board

May 11 2014 8:30AM - May 11 2014 5:30PM | Shanghai International Convention Center No. 2727, Riverside Avenue Pudong 200120 Shanghai China

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Overview 

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.

Learning Objectives 

  • 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

Contact Information 

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

For exhibiting, hosting, and advertising inquiries, contact
Ms. Jean XU
Phone: +86.10.5923.1096
jxu@kellencompany.com

To Register, click here.

Instructor(s) 

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