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Safety assessment and reporting

Author:
WWARN

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 authorization 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.

Safety assessment and reporting

zip
26 November 2018
Safety assessment and reporting
v1.0
zip
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