This form must be completed in the event of an SAE or SUSAR occurring in a Clinical trial which falls within the remit of the Medicines for Human Use (Clinical Trial) Regulations 2004 and where the Sponsor responsibility of Pharmacovigilance has been accepted by King’s College London, Guy’s & St Thomas’ NHS Foundation Trust, or King’s College Hospital NHS Foundation Trust.
This form is to be completed as soon as possible after the clinical trial staff have been made aware of the event and sent immediately to the KHPCTO
by email: jcto.pharmacovigilance@kcl.ac.uk
The KHP CTO will acknowledge receipt of the SAE Report using the KHP CTO SAE Receipt Form. If a receipt is not received within 24hrs of sending the report (during office hours), the SAE Report Form should be re-sent.
As of the 23rd of April 2018, KHPCTO will be applying MedDRA coding to all SAE reports. If you are familiar with MedDRA terminology, please use it to describe the event. If not, you may be contacted by a representative of the CTO to confirm the correct terminology for the event.
Additional information, as it becomes available, will also be reported on the SAE report form and returned to the KHP CTO by email as above. The original SAE Report Form will be filed in the Trial Master File, with copies filed in the patient’s hospital notes, the case record form, the Investigator Site File (if applicable) and the Sponsor file.
For more information on completing the SAE form and submission requirements, please see the SAE From completion guidelines below:
Serious Adverse Event Reporting Form (650KB)
Serious Adverse Event Form Completion Guideline V3 (350KB)
