Safety assessment and reporting

A process for the identification, management, assessment, and reporting of adverse events/adverse drug reactions

 

 

Publication Version
v1.0
Publication Code
SAF01
Procedure Author
Mekong Molecular Surveillance Network

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.

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