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Safety reporting (adverse events)

Throughout the course of your study it is important to ensure appropriate reporting arrangements are in place for recording adverse and serious adverse events.

Adverse events

An adverse event is any untoward medical occurrence in a subject to whom a medicinal product/medical device/intervention has been administered, including occurrences which are not necessarily caused by or related to that product/device/intervention.

An event/reaction is serious if it:

  • results in death
  • is life threatening
  • results in persistent or significant disability/incapacity
  • requires hospitalisation
  • prolongs a current hospitalisation
  • results in a congenital anomaly or birth defect

Serious Adverse events

Once an event has been classified as serious (an SAE), an assessment needs to be made by the Principal Investigator (PI) or delegated individual in the PIs absence as to whether the event is related to the study treatment/intervention and an 'unexpected' event. If an event is both related and unexpected it becomes a SUSAR - Suspected Unexpected Serious Adverse Reaction. These events need to be reported to the Sponsor immediately and the provisions for reporting will be detailed in the Protocol (which should also contain a list of 'expected' events). Depending on whether an event is an SAE or SUSAR, there are specific reporting requirements with urgent timelines that must be met. More information on these can be found in our Standard Operating Procedure (SOP) 'Research Safety Reporting'. If you are still unsure of your requirements please contact the R&I office and ask to speak to a member of the monitoring team on 0117 34 20233.

Template forms which can be used to report adverse events can be found on the Templates and Guidance page. If UH Bristol is the Sponsor then use of these forms is mandatory.

Safety reporting process (SAEs) over the bank holiday period - (please also refer to the Research Safety Reporting SOP)

If you need to report an SAE, please email it to research@uhbristol.nhs.uk 

In this event, ensure one of the following is done:

1. Scan and attach to the email a hard copy of the SAE report which the PI has signed. OR

2. Send the SAE report from the PI's email address to confirm signature electronically. OR

3. Send an unsigned copy of the SAE report by email, followed up by a signed copy as soon as possible.

If the PI is unavailable and there is a delegated clinician, please send a copy of the SAE report signed by the delegated clinician, by email as described above (1&2).

Fatal/life threatening SUSARs will be reported onwards by R&I to the MHRA using the e-submission reporting function within 7 days. The research team should report the SUSAR to the REC within 7 days of the report to us. If a SUSAR is not fatal or life threatening the reporting period is 15 days.