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Protocol Deviation Handling
Omar Hamidi, Clinical Project Data Manager
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Protocol Deviation Handling
Process Define list of important PDs Identify, classify and document PDs Process PDs Review and update Root cause analysis, if applicable Trending
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Protocol Deviation Handling
Define list of important PDs Trial-specific list Template from SOP Defined by clinical trial team
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Protocol Deviation Handling
Identify, classify and document PDs Monitor identifies PDs Automatic checks identify potential PDs PDs identified by others are communicated to monitor Classify as important or non-important Document in PD log
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Protocol Deviation Handling
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Protocol Deviation Handling
Auto Monitor Auto
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Protocol Deviation Handling
Process PDs Process PDs Review and update Root cause analysis, if applicable Trending
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Protocol Deviation Handling
Trial Manager
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Protocol Deviation Handling
Process PDs Print Individual – PDF Complete log - Excel
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Protocol Deviation Handling
Process PDs - Trending
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Protocol Deviation Handling
Process PDs - Trending
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