Null Case | PharmaBharat Tools

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Null Case | PharmaBharat Tools

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Literature Screening Medical Information Request Stimulated Reporting Direct Patient Reporting Patient Support Programme(PSP)Lack of Efficacy Product Quality Complaint Medication Error Null Case Invalid Case Initial Report Awareness Date Receipt Date Report Source Regulatory Report Study Report Literature Case Company Representative PV Contact Intake Triage Urgent Report Local Literature Screening Awareness Date Clock Start Consumer Report Day Zero(D0)Duplicate Detection Follow-up Report(FU)Healthcare Professional(HCP)Identifiable Patient Identifiable Reporter Initial Report Literature Report Medical Information Request(MIR)Minimum Information(MI)Reporter Type Solicited Report Source Document Spontaneous Report Triage Valid Case Worldwide Safety Database(WWSD)

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PV Case Intake & TriageNull Case

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Medication Error Invalid Case

Null Case

Case Intake & Triage

Definition

Report that after assessment does not meet criteria for valid case or reportable case.

Example

No identifiable patient—null case; document and archive.

Regulatory source

ICH E2D

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