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Risk-Based Monitoring: Where We Are and Where We Are Headed
Session Chair(s)
Amita Malik, MS
Product Director
Oracle Health Sciences, United States
Risk-Based Monitoring: Overview of the Current State and Guidelines on How to Design and Execute a Risk-Based Monitoring Plan
Learning Objective : Define the critical steps to develop and implement guidelines for a successful risk-based monitoring (RBM) strategy; Discuss the challenges in implementing an RBM plan (from both a sponsor and site perspective); Identify methods to overcome the challenges encountered when deploying an RBM strategy; Determine ways to effectively utilize technology as part of an RBM strategy.
Speaker(s)
Risk-Based Monitoring: Overview of the Current State and Guidelines on How to Design and Execute a Risk-Based Monitoring Plan
Amita Malik, MS
Oracle Health Sciences, United States
Product Director
Addressing Key Aspects of the EMA Reflection Paper on Risk-Based Quality Monitoring: Quality Tolerance Limits and Quality Report
William Andrew Lawton
Risk Based Approach Ltd, United Kingdom
Director / Consultant
Experience Conducting Studies with Risk-Based Monitoring Strategies
Nycole Ramirez, BSN, MA, RN
ICON, United States
Sr. Manager Clincial Risk Management, Clinical Research Services
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