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Computer-Assisted Method for Adaptive, Risk-Based Monitoring of Clinical Studies
Computer-Assisted Method for Adaptive, Risk-Based Monitoring of Clinical Studies
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机译:基于计算机辅助方法的适应性,基于风险的临床研究监测
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摘要
A computer-assisted method is described for continuously assessing the quality of field data in a clinical study, identifying areas of weakness and specific sites where performance may be less than desirable, and flexibly allocating resources to address the problems, including the need to travel to the site to either check data or address problem areas. This method involves specification of key performance indicators that include elements that, preferentially, can be measured from a central location and do not require physical presence at the site to be checked. Such indicators can be continuously evaluated for correlation with desired performance levels, and modified accordingly. This approach thus is both risk-based and adaptive, and specifically enables clinical trial managers to address quality issues without the need to travel to the sites.
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