SUSAR and SAE Reporting

All adverse drug reactions (ADRs), which are both serious and/or unexpected, are to be reported to JPEC. In the case of 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, using the JPEC Serious Adverse Event Report.

For SAEs outside of the investigator’s institution (applicable in multicentre trials):

a) Only Suspected, Unexpected and Serious Adverse Reaction (SUSAR) are to be submitted to JPEC

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

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

d) Only protocol specific investigational product(s) SUSARs are to be submitted to JPEC.

e)All periodic SUSAR reporting (line listing) are to be accompanied by a brief report by sponsor highlighting main points of concern, if any.

f)Annual Safety Report is expected on an annual basis throughout the whole clinical trial course. This report will describe concisely all new safety information relevant for the trial and to assess the safety conditions of subjects in the trial.