SUSAR Reporting to Investigators

It is exciting to have recently seen a few companies and vendors embracing the idea of sending SUSAR linelistings to investigators in lieu of individual CIOMS.

This has been allowed per ICH, EU, Australia and now the UK, but companies were hesitant to implement. When there was no longer a legal requirement to distribute six month linelistings, I advised clients to stop - if they were sending individual CIOMS it was redundant.

I am now excited to advise the opposite – send linelistings in lieu of CIOMS! However for companies with a very low SUSAR volume, take care that you are not creating more work by requiring yourself to send something out every six months, even if you have no SUSARs...

Reference:  ICH E6 (R3) (see 1.13.2.d), the EU CTR (EU) 536/2014 Q&A Version 7.2 (see Question 7.31), MHRA Guidance on Clinical Trials for Medicines (see Reporting SUSARs – legal basis), and Australia’s Safety Monitoring and Reporting In Clinical Trials Involving Therapeutic Goods.