Serious Adverse Event (SAE) Reporting
This page provides SAE reporting 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), Suspected Unexpected Serious Adverse Reactions (SUSARs), Important Medical Events (IMEs) and pregnancies.
Report and manage adverse events in clinical trials
This page provides SAE reporting 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), Suspected Unexpected Serious Adverse Reactions (SUSARs), Important Medical Events (IMEs) and pregnancies.
SAEs must be reported as soon as possible after clinical trial staff have been made aware of the event.
If you have been advised that SAEs for your trial should be reported via SAE Dundee (the KHP-CTO’s new pharmacovigilance reporting system), please click here to log in to SAE Dundee. If you do not have a login for SAE Dundee, please click here to request your login. For any issues procuring your login, please email: KHPCTO.CommercialData@kcl.ac.uk
If you have not been advised that SAEs for your trial should be reported via SAE Dundee, please email a completed SAE Reporting Form to: jcto.pharmacovigilance@kcl.ac.uk and the KHP-CTO will acknowledge receipt within 24hrs.
Please ensure SAE 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 V1.1
Step-by-step guide to creating, reviewing and signing off safety reports in SAE Dundee
Introduction to SAE Dundee Video Handout V1.3
This handout contains the slides presented in the SAE Dundee introductory video.
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.