Live Webinar
on
Ensure the Safety of Clinical Trials: The Roles of Data Safety Monitoring Boards (DSMB) and Institutional Review Boards (IRB)
Date & Time: Thursday, December 1, 2011
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Alex Aptovcov
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Alex Aptovcov Senior Clinical Research Consultant,
This presentation will review the definition, purpose, composition, guiding documents, responsibilities of DSMB, its role in the Data and Safety Monitoring Plan, the role of IRBs and DSMBs in clinical studies, PI's responsibility of AE reporting, and finally discuss which studies would benefit from the DSMB's involvement.
Why you should attend: This presentation highlights the roles of DSMBs and IRBs in ensuring the safety of the clinical studies. Sponsors and CROs contemplating to conduct complex studies should consider the involvement of DSMB to ensure that the safety data is reviewed by an independent group. Investigator site need to be aware that the data reported from their site will be reviewed by an independent group (other than Sponsor or CRO).
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Alex Aptovcov MD, MBA, Senior Clinical Research Consultant based in Ontario, Canada. Alex holds the degrees of Doctor of Medicine from the National Medical University, Kiev, Ukraine and Masters of Business Administration, Victoria, British Columbia, Canada. Alex has more than fifteen years of clinical research experience - as sub-Investigator in Ukraine, Patient Recruitment Consultant in New York and as Clinical Research Consultant (Canada, USA). For the last four years, Alex has worked on complex studies which involved the data review from DSMBs. ...more
What is a DSMB? What is the purpose of DSMB? Composition of a DSMB. Guidelines (charter) of DSMBs Responsibilities of the DSMB Elements of Data and Safety Monitoring Plan (DSMP). The role of the DSMB and IRB in clinical studies The role of the IRB with regard to DSMB and DSMP. AE reporting - investigator's responsibility Why do I need a DSMB?
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