Serious Adverse Event (SAE) Reporting
This page provides the SAE reporting form, guidance, and related documents for trials where King’s Health Partners holds pharmacovigilance responsibility. Use these resources to report and manage Serious Adverse Events (SAEs) and SUSARs (Suspected Unexpected Serious Adverse Reaction).
Report and manage adverse events in clinical trials
This page provides the SAE Reporting Form, guidance, and supporting documents required when reporting Serious Adverse Events (SAEs) or SUSARs (Suspected Unexpected Serious Adverse Reaction) in trials where pharmacovigilance responsibilities lie with King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust or South London and Maudsley NHS Foundation Trust.
You must complete his form as soon as possible after clinical trial staff have been made aware of the event. Please email the completed form immediately to us: jcto.pharmacovigilance@kcl.ac.uk
We will acknowledge receipt of the SAE Report. If a receipt is not received within 24hrs of sending the report (during office hours), the SAE Report Form should be re-sent.
Please ensure reports are submitted promptly and in accordance with the guidance provided.
Forms and guidance
SAE Reporting Form V2.8
SAE Report Form
SAE IMP & Con Med Extra Page V2.8
SAE IMP & Con Med extra form (if needed)
SAE Reporting Form Guide V3.2
Guide for completing the paper SAE Reporting Form
SAE Dundee User Guide V1.0
Step-by-step guide to creating, reviewing and signing off safety reports in SAE Dundee
Useful links
KHP CTO Pharmacovigilance Policy (v10.0)
Policy V10.0 is to be used with the ‘paper based’ SAE reporting system.
KHP CTO Pharmacovigilance Policy (v11.0)
Policy V11.0 is to be used with the new SAE Dundee system when implemented.