Safety assessment and reporting

Ensuring the safety of participants in clinical trials is an ethical requirement, while it is necessary to also characterise the safety profile of a drug by the time of its marketing authorisation application (and beyond). In practical terms at the investigational site, safety monitoring involves the prevention, identification, management, assessment, and reporting of adverse events/adverse drug reactions. This procedure describes a standardised procedure as such suitable for antimalarial drug efficacy trials but may be adapted for other trial designs and specific protocols.