SAE Reporting

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 KHP CTO by fax 020 7188 8330 or email: jcto.pharmacovigilance@kcl.ac.uk

The KHP CTO will acknowledge receipt of the SAE Report using the KHP CTO SAE Form Receipt Form. If the CI has not received receipt within 24hrs of sending the report (during office hours), the SAE Report Form should be re-sent to the KHP CTO by email or fax.

Additional information, as it becomes available, will also be reported on the SAE report form and returned to the KHP CTO by email or fax 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:

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