Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting

Abstract Background Although adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of m...

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Hlavní autoři:	Gwenllian Moody, Katy Addison, Rebecca Cannings-John, Julia Sanders, Carolyn Wallace, Michael Robling
Médium:	Artigo
Jazyk:	Inglês
Vydáno:	BMC 2019-12-01
Edice:	Trials
Témata:	Safety monitoring Adverse event Serious adverse event Public health Clinical trials Home visiting
On-line přístup:	https://doi.org/10.1186/s13063-019-3961-8
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