Using Vulnerable Populations in Clinical Research.

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Human Subject Protection in Clinical Research

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Subject Recruitment in Clinical Trials

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Risk Based Monitoring in Clinical Trials.

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Advance Monitoring in Clinical Trials.

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Signal Detection in Pharmacovigilance

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De-challenge and Rechallenge

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Causality Assessment in Pharmacovigilance

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Narrative Writing

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Medical Coding

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Types of Adverse Drug Reactions (severity)

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Collection, Processing and Reporting of ICSR

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Audit and Inspection in Clinical Research

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Introduction to ATC Coding

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ICSR (individual case safety report)

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Reporting of ICSR (individual case safety report)

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Good Pharmacovigilance Practices and Guidelines

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Causality Assessment

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