Pharmacovigilance

Processes for identifying, documenting, and reporting adverse events and safety concerns to protect participants and maintain compliance.

PV001 Pharmacovigilance: Receipt, Onward Reporting and Follow-Up of Safety Reports

Guidelines for the reporting of adverse events in clinical trials.

SOP v10.0 (920.79 KB / 0)

PV002 Pharmacovigilance: Sponsor Overview and Trend Analysis

SOP v5.0 (878.51 KB / 0)

PV003 Pharmacovigilance Reference Safety Information and Drug Alerts

SOP v5.0 (871.87 KB / 0)

PV004 Pharmacovigilance: MedDRA coding SAEs for DSURs

SOP v4.0 (447.37 KB / PDF)

PV005 Receipt, Onward Reporting And Follow-Up Of Safety Reporting For Regulated Medical Device Studies v1.0

SOP v4.0 (876.72 KB / 0)

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