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 v11.0 (937.03 KB / 0) Document PV001-F01 SAE Summary Sheet v8.0 (170.57 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 Sponsor Overview and Trend Analysis v6.0 (915.76 KB / 0) PV003 Pharmacovigilance Reference Safety Information and Drug Alerts Document PV003 Pharmacovigilance - RSI and Safety Alerts v6.0 (897.62 KB / 0) PV004 Pharmacovigilance: MedDRA coding SAEs for DSURs Document PV004 Pharmacovigilance MedDRA Coding SAEs for DSURs v5.0 (865.14 KB / 0) Document PV004-T01 Line Listing Header template v2.0 (19.11 KB / 0) 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
