Impact of monitoring approaches on data quality in clinical trials.
British journal of clinical pharmacology(2022)
摘要
These empirical data, directly comparing RBM with CM, suggest that RBM improves data quality regarding data-points of major importance to trial outcomes, efficacy and major safety. Overall, the RBM approach showed a correlation to reduced amount of data collection errors with major relevance for interpretation of study results and subject safety as well as reducing on-site monitoring and data cleaning resources.
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关键词
clinical trial monitoring,cost-benefit,data error analysis,risk-based monitoring,source data verification
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