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Using Independent Data Safety Monitoring in Clinical Research Date: Tuesday, May 28, 2013 Duration:
90 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Charles H Pierce
Overview: All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
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The historical background of why Data and Safety monitoring is essential The purpose of the Data and Safety monitoring plan The Regulatory requirements for safety monitoring Studies requiring a formal Safety monitoring plan What does the "Charter" of a DSMB compose of? What is the composition and function of a DSMB? What types of studies "require" a DSMB? Conflict of interest and the DSMB
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Principal Investigators and sub investigators, Clinical Research Scientists Safety Nurses Clinicl Research Associates (CRAs) and Cordinators (CRCs) Recruiting staff QA / QC auditors and staff Clinical Research Data managers
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About Speaker Charles H Pierce Consultant, Clinical Research / Drug-Device Development Charles H Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, ... more
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