An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units
Abstract Background Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-...
Main Authors: | , |
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Format: | Article |
Language: | English |
Published: |
BMC
2019-09-01
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Series: | Trials |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s13063-019-3619-6 |