Study Report | PharmaBharat Tools

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Study Report | PharmaBharat Tools

Categories

Aggregate Reporting(35)

AI & ML in Pharmacovigilance(21)

Audit & Inspection Readiness(30)

Audits & Inspections(20)

Case Intake & Triage(42)

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)

Case Processing & Data Entry(49)

India CDSCO & PvPI(20)

Data Privacy & Masking(21)

GVP & ICH Updates 2026(9)

Medical Review(26)

Quality Review(46)

Real-World Data & RWE(21)

Regulatory Harmonization(12)

Regulatory Reporting(83)

Risk Management(68)

Seriousness & Causality Assessment(34)

Signal Detection & Validation(43)

Signal Management(20)

Progress

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PV Case Intake & TriageStudy Report

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Regulatory Report Literature Case

Study Report

Case Intake & Triage

Definition

Report from a clinical trial or non-interventional study.

Example

AE from Phase III trial—study report.

Regulatory source

ICH E2D

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