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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
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Problem
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RACT FRAMEWORK
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MONITORING PLAN
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Problem
RACT IQRMP RISK INDICATORS
• WEAK LINKS / LOOSELY CONTROLLED
• NO EFFECTIVE CHANGE MANAGEMENT
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Solution
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Practical Examples
RACT IQRMP RISK INDICATORS
• Example 1: Subject Safety
• Example 2: Data Integrity
• Example 3: Regulatory Compliance
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Subject Safety
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Subject Safety
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Subject Safety
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Subject Safety
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Subject Safety
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Subject Safety
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Data Integrity
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Data Integrity
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Data Integrity
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Data Integrity
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Data Integrity
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Data Integrity
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Regulatory Compliance
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Regulatory Compliance
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Regulatory Compliance
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Regulatory Compliance
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Regulatory Compliance
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Summary
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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