Adverse Event

Adverse Event • Is it Serious? • i.e. resulted in: • Death • Life Threatening • Hospitalisation (or prolongation of hospitalisation) • Disability • Congenital abnormality/birth defect • Important medical event/medical intervention Record in CRF if required by protocol No Yes Record SAE for inclusion in annual report Is it Related? i.e. Is there a causal relationship with the treatment No Yes Is it Unexpected? i.e. not previously documented in protocol or investigator brochure Record SAE for inclusion in annual report No Yes Is it Fatal or Life Threatening? No Yes Report SUSAR to MHRA and main REC within 15 days Report SUSAR to MHRA and main REC within 7 days The day on which the SAE is first reported is day zero and all timelines are calculated as calendar days i.e. weekends, bank holidays are included Follow up with detailed report within a further 8 days Copy of SAE report & related correspondence filed in TMF

Adverse Event

Adverse Event

Presentation Transcript

FDAH Adverse Event Report Re-analysis

New Adverse Event Reporting Policy

Serious Adverse Event and Reaction reporting

Adverse Event – Regulations Requirement of the IRB

DHS Adverse Event Reporting Requirements

Adverse Event Reports for External Defibrillators 2005 – 2010

Improving Patient Safety Through Adverse Event Reporting

Serious Adverse Event Reporting

Industry Adverse Event Subcommittee (*= SC member)

Adverse Event Reporting

Adverse Drug Event Reporting

RESCUE 4701 Adverse Event Reporting October 16, 2010

Adverse Event Management

Session 4 Adverse Event Reporting

Adverse Event reporting in clinical trials

Status of Adverse Event Public Reporting

Vaccine Adverse Event Reporting System (VAERS)

Adverse Event Reporting: Getting started

Adverse Event Reporting: Trials and Tribulations

Expedited Adverse Event Reporting Requirements

GCPs V Adverse Event Monitoring and Reporting