Risk-based Monitoring of Clinical Trials: An Integrative Approach.
Sign Up to like & getrecommendations! Published in 2018 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2018.04.020
Abstract: PURPOSE Clinical trial monitoring is an essential component of drug development aimed at safeguarding subject safety, data quality, and protocol compliance by focusing sponsor oversight on the most important aspects of study conduct. In recent… read more here.
Keywords: risk; based monitoring; monitoring clinical; risk based ... See more keywords
Remote digital monitoring in clinical trials in the time of COVID-19
Sign Up to like & getrecommendations! Published in 2020 at "Nature Reviews Drug Discovery"
DOI: 10.1038/d41573-020-00094-0
Abstract: can be used in clinical trials to evaluate novel end points that provide information that was previously difficult or impossible to obtain. These technologies could also make trials more efficient and less burdensome to participants… read more here.
Keywords: monitoring clinical; clinical trials; remote digital; digital monitoring ... See more keywords
On-site monitoring of clinical trials by an Ethics Committee in India: a road less travelled
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DOI: 10.1177/1747016120933923
Abstract: Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics… read more here.
Keywords: ethics committee; monitoring clinical; site monitoring; trials ethics ... See more keywords
Factors that interfere with the response of nurses in the monitoring of clinical alarms.
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DOI: 10.1590/0034-7167-2015-0092
Abstract: Objective: The objective of the present study was to identify and synthesize the best empirical evidence found on factors that influence the response of nurses regarding clinical alarms. Method: An integrative literature review was conducted… read more here.
Keywords: interfere response; clinical alarms; monitoring clinical; nurses monitoring ... See more keywords