SUSAR Reporting in the UK

[SYH]

Is there any guidance regarding when SUSARS can stop being sent to sites? Should they be sent until the site is closed? Or can this be at the discretion of the investigator if all patients are in long term follow up? I am thinking of situations such as oncology studies where all of the patients may be in long term follow up for some time, and the investigator may only wish to receive the 6 monthly and annual reports.

[PinkLady]

In our long-term follow-up studies we only expect Investigators to review Six-monthly Safety Reports, not individual SUSARs. Fortunately the regulations are vague enough to not specify the exact format of how Investigators should receive SUSARs (or when), so as long as you agree & define your own process in your own SOP and you follow it, I don't believe it matters how you send the SUSARs (either individually or in SSRs).