Disability Significant | PharmaBharat Tools

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Disability Significant | PharmaBharat Tools

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PV Seriousness & Causality AssessmentDisability Significant

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Hospitalization Prolonged Temporal Relationship

Disability Significant

Seriousness & Causality Assessment

Definition

Seriousness: substantial disruption of ability to conduct normal life functions.

Example

Permanent hearing loss—disability.

Regulatory source

ICH E2D

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