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Live Webinar on
Using Independent Data Safety Monitoring in Clinical Research – How and Why Date:
Tuesday, April 09, 2013
Time:
10:00 AM PDT | 01:00 PM EDT
Instructor: Charles H Pierce Duration
90 Minutes
Location:
Online
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... .more
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. Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices. Depending on the nature of the test agent, the vulnerability of the study population, the length of the study, or the number of sites conducting the clinical study. The "Plan" increasingly has the "Charter" of what is called a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB).
Areas Covered in the Session: l l l l l l l l
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 Committee What does the "Charter" of a DMC compose of? What is the composition and function of a DMC? What types of studies "require" a DMC? Importance of avoiding a Conflict of interest in the DMC members
Who Will Benefit: l
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Pharmaceutical, Biological and device companies with an active pipeline of products and planning on global studies Principal Investigators and sub investigators Clinical Research Scientists Research Managers
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Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs) Recruiting Staff QA / QC Auditors and staff Study Monitors
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Clinical Research Data managers
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