The regulation state all SAEs should be reported to the sponsor within 24 Hours. If the sponsor delegate this task to a third party, does third party still obliged to report these SAE to the sponsor?
What mechanism should be in place to ensure sponsor has the oversight on safety reporting.
Information that I have come across:-
The 24 hours is the time to get the SAE report to the Sponsor performing SAE/SUSAR reception and evaluation. If the Sponsor has set up a system where that notification has to go to the CRO first, then they need a robust process to ensure that the CRO passes it on immediately to the sponsor to meet that requirement.
There could be a scenario where a Sponsor outsources almost everything (but obviously not the oversight of the CROs by the sponsor,- that always remains a sponsor responsibility). This would mean that the reception and evaluation of SAE/SUSARs will be performed by a legally contracted vendor/CRO. In that scenario it would be expected that the investigator report in 24 hours to the CRO – essentially the timeline is there to make sure that the information gets quickly to those that need to report it, and of course within the legislative timelines to the Regulatory Authorities
With regard to "oversight" I suggest that you look at the MHRA blog on GCP oversight. Also the EMA TMF guidance (on the EMA Inspectors Working Group website) has information about contacts and oversight with CROs that perform TMF tasks, this could be useful when deciding what might be useful for oversight of other duties.
Thank you, the reception and evaluation task has been assigned to CTU who will QC check and conduct expectedness. However I was trying to establish if it is okay that CTU report these SAE data every two months in a report format to the sponsor?Originally Posted by a123456
I asked a similar question and got a reply from MHRA Inspector G. Francis 01 July 2019:-
A: The 24 hours is to get to the Sponsor. If the Sponsor has set up a system where that notification has to go to the CRO first, then they need a robust process to ensure that the CRO passes it on immediately to the sponsor to meet that requirement.
Follow-up Q: If the Sponsor outsources almost everything (but obviously not the oversight of the CROs by the sponsor, which remains a sponsor responsibility) this means that the reception and evaluation of SAE/SUSARs will be performed by a contracted CRO. In that case I assume that the 24 hours timing is from the investigators first awareness to reporting to the CRO with SAE/SUSAR evaluation and reporting responsibilities. Is that right?
A: Yes, in that scenario we would expect the investigator to report in 24 hours to the CRO – essentially the timeline is there to make sure that the information gets quickly to those that need to report it, and of course within the legislative timelines to the Regulatory Authorities
Documenting Oversight is usually a function of your Risk Assessment to determine. The EMA IWG gives some slight guidance in their Q & A :- " The sponsor/CRO should determine the extent of monitoring of each party, within the context of GCP, under particular circumstances. This should be justifiable, and ensure GCP compliance, in the context of the clinical site organisation and the nature of the product and protocol being studied. "
Thank you for this information, really helpful
At last we managed have access to database system. As soon as sit reports a SAE, we will be notified by an email and now we can go in o the system and see the details.
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