mapping protocol level risks to visual indicators and thresholds at the rbm planning stage, some...
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Mapping protocol level risks to visual indicators and thresholds at the RBM planning stage, some practical
examples
Nick Hargaden22nd October 2014
eCF US Conference 2014, Boston
Problem
RACT FRAMEWORK
MONITORING PLAN
Problem
RACT IQRMP RISK INDICATORS
• WEAK LINKS / LOOSELY CONTROLLED
• NO EFFECTIVE CHANGE MANAGEMENT
Solution
Practical Examples
RACT IQRMP RISK INDICATORS
• Example 1: Subject Safety
• Example 2: Data Integrity
• Example 3: Regulatory Compliance
Subject Safety
Subject Safety
Subject Safety
Subject Safety
Subject Safety
Subject Safety
Data Integrity
Data Integrity
Data Integrity
Data Integrity
Data Integrity
Data Integrity
Regulatory Compliance
Regulatory Compliance
Regulatory Compliance
Regulatory Compliance
Regulatory Compliance
Summary
Summary
RACT IQRMP RISK INDICATORS
• Process links can be effectively controlled by technology
• Any amendments in the protocol are tightly controlled with RACT and its associated plans and its associated alert or indicators
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