Table 1 Summary of safety reporting responsibilities[7]

Report serious adverse events to the sponsor as per the protocol

Keep detailed records of all adverse events which are reported by the investigator or investigators

Report certain non-serious adverse events and/or laboratory abnormalities to the sponsor as per the protocol

Report suspected unexpected serious adverse reactions (SUSARs) to the national competent authority and the Ethics Committee

Inform investigators of SUSARs

Submit an annual safety report to the national competent authority and the Ethics Committee

Continuously weigh anticipated benefits and risks of the clinical trial which includes ongoing safety evaluation of IMPs