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

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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Bibliographic Details
Main Authors: Gwenllian Moody, Katy Addison, Rebecca Cannings-John, Julia Sanders, Carolyn Wallace, Michael Robling
Format: Article
Language:English
Published: BMC 2019-12-01
Series:Trials
Subjects:
Safety monitoring
Adverse event
Serious adverse event
Public health
Clinical trials
Home visiting
Online Access:https://doi.org/10.1186/s13063-019-3961-8

Internet

https://doi.org/10.1186/s13063-019-3961-8

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