For serious adverse events (SAEs) occurring in the investigator’s institution, the investigator is to notify the JPEC Chairperson within 24 hours of its notification to the investigator.

Investigator is to report (cc. local investigator) the fatal/life-threatening SUSAR to JPEC within 7 calendar days from first knowledge. If there is additional information, this should be submitted within 8 calendar days.

Those that are non-fatal/life-threatening SUSARs, to submit to JPEC within 15 calendar days from first knowledge.