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.

PV002 Pharmacovigilance: Sponsor Overview and Trend Analysis

PV003 Pharmacovigilance Reference Safety Information and Drug Alerts

PV004 Pharmacovigilance: MedDRA coding SAEs for DSURs

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