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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Автори:	Gwenllian Moody, Katy Addison, Rebecca Cannings-John, Julia Sanders, Carolyn Wallace, Michael Robling
Формат:	Artigo
Мова:	Inglês
Опубліковано:	BMC 2019-12-01
Серія:	Trials
Предмети:	Safety monitoring Adverse event Serious adverse event Public health Clinical trials Home visiting
Онлайн доступ:	https://doi.org/10.1186/s13063-019-3961-8
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