All Serious Adverse Reactions (SARs) MUST be reported to bsctusafety@bsms.ac.uk within 24 hours of the research team being aware of the event.

SARs are Serious Events that are Definitely, Probably or Possibly related to the Intervention. Causality Assessmentmust be made by a medically qualified doctor on the delegation log.

In the interests of timely reporting, it is acceptable to submit an initial report without full details or a PI/Co-Investigator signature.

If the initial report is submitted without a PI/ co-investigator signature, it must be followed up with a signed copy reporting expectedness and causality ASAP within 2 working days of the initial form being submitted.

Once a signed initial report is received a follow up should be submitted as soon as there are any updates to the SAR. If the patient is still an inpatient or there is an unavoidable delay in the provision of further information, inform the BSCTU as soon as possible.

Should there be a requirement for clarification or further information required an email detailing the request will be sent. Response to the request is required as per the timelines dictated in the email.

The minimum acceptable information for an initial SAR report is:

- Patient Study ID

- SAR term- ideally this should be an overall diagnosis however if not known at the time of reporting, presenting symptoms can be listed instead. The CTCAE Version 4.03 Grading Scale should be used.

- Intervention details

- The seriousness criteria 

All supporting documentation must have all patient identifiable data removed. The documents MUST only be identified with the addition of the patient study ID and initials.

If you have queries regarding your SAR submission, please contact bsctusafety@bsms.ac.uk or the REDUCe2 Trial Manager, Alison Porges, on 07721 860469.