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. Document PV001 Pharmacovigilance: Receipt, Onward Reporting and Follow-Up of Safety Reports v10.0 (920.79 KB / 0) Document PV001-F01 SAE Summary Sheet v7.0 (169.46 KB / 0) Document PV001-T01 CIOMS Form SAR SUSAR Report v2.0 (157.79 KB / 0) PV002 Pharmacovigilance: Sponsor Overview and Trend Analysis Document PV002 Pharmacovigilance: Sponsor Overview and Trend Analysis v5.0 (878.51 KB / 0) PV003 Pharmacovigilance Reference Safety Information and Drug Alerts Document PV003 Pharmacovigilance Reference Safety Information and Drug Alerts v5.0 (871.87 KB / 0) PV004 Pharmacovigilance: MedDRA coding SAEs for DSURs Document PV004 Pharmacovigilance: MedDRA coding SAEs for DSURs v4.0 (447.37 KB / PDF) PV005 Receipt, Onward Reporting And Follow-Up Of Safety Reporting For Regulated Medical Device Studies Document PV005 Receipt, Onward Reporting And Follow-Up Of Safety Reporting For Regulated Medical Device Studies v4.0 (876.72 KB / 0) Document PV005-F01 SAE Summary Sheet CIMD v3.0 (169.21 KB / 0) This article was published on 2024-11-07
