Basics - Part 14 - SUSAR Suspected Unexpected Serious Adverse Reaction

[@fredrikh9299]

Thank you!

[@dongwang1801]

Thanks!

[@okellomaurice6073]

Given the timelines for reporting of the SUSARs by the sponsor, how long should it take for the sites to report to the sponsor? Especially those sites which are multinational.

[@varunsharma7521]

Well explained, thank you 👍

[@GCPMindset]

Glad you liked it

[@Lamp141]

What are the requirements for cross reporting of foreign SUSAR?

[@dheerajkanoj7066]

What is casuality for SUSAR?

[@vivekrakha5295]

Good video

[@GCPMindset]

Thanks

[@sindhusetty2724]

Can you pls tell me like if a serious adverse event was unexpected as per IB and expected as per ccds or rsi can we consider as susar, pls tell me

[@GCPMindset]

The reference safety information should be defined before the start of the study. Usually, the reference safety information is a specific section in the IB. If the event is not listed in this section, the event is considered unexpected.