Why are we Seeing More Independent Data Safety Monitoring 2017

Topics

• The purpose of the Data and Safety monitoring plan
• The historical background of why Data and Safety monitoring is essential
• Studies requiring a formal Safety Monitoring Committee
• The Regulatory requirements for safety monitoring
• What is the composition and function of a DMC?
• What does the "Charter" of a DMC compose of?
• Importance of avoiding a Conflict of interest in the DMC members
• What types of studies "require" a DMC?

Who should Attend

• Principal Investigators and sub investigators
• Biological, Pharmaceutical and medical device companies
• Research Managers
• Clinical Research Scientists
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Safety Nurses
• QA / QC Auditors and staff
• Recruiting Staff
• Clinical Research Data managers
• Study Monitors