ECSafetyReporting object

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

Sponsor + Institutional Research Ethics Committees (IKEB)

Immediately (without delay)

Sponsor

Immediately
Within a max of 7d upon first knowledge (+ 8d for additional information)

Within a max of 15d upon first knowledge

Yes

Detailed information is available on OGYÉI website in section: AR reporting arising from clinical trials.

Section 21 & 22 Decree No 35/2005

• Sponsors of commercial studies shall immediately report any SUSAR from clinical trials via the EudraVigilance system to EMA (OGYÉI in case of non-commercial studies).

• Safety Notification Letters should be sent to NIP/ OGYÉI immediately but at latest 24 hours, if the new events affect the conduct of the trial or the safety of the subjects considerably.

• Sponsors should report only those SUSARs to NIPN/OGYÉI where the primary source country is Hungary.
The sponsor shall notify all investigators participating in the clinical trial on any SUSAR.

• NB! Recent changes regarding AE reporting:
Development Safety Update Report (DSUR) report is mandatory to be provided to CA and competent EC on CD.
SUSAR Line Listing must be sent only to investigators according to the guideline of European Commission ("Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use” (2011/C 172/01 section 7.10.).