Seriousness Reclassification | PharmaBharat Tools

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Seriousness Reclassification | PharmaBharat Tools

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PV Case Processing & Data EntrySeriousness Reclassification

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Pending Follow-Up Verbatim Term

Seriousness Reclassification

Case Processing & Data Entry

Definition

Change from non-serious to serious (or vice versa) based on new information; may create new Day 0.

Example

Follow-up reveals hospitalization—reclassify as serious; new Day 0.

Regulatory source

ICH E2D, GVP VI

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