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Updated: Aug 14, 2026

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
Data monitoring committees and capturing relevant information of high quality
1Department of Biostatistics, University of Washington, Seattle 98195.
Abstract:
The integrity and credibility of randomized clinical trials, designed to provide a definitive evaluation of therapeutic interventions, can be substantially enhanced if periodic review of results on the relative efficacy of treatments is conducted by a data monitoring committee (DMC). The role of the DMC can include some important activities which promote obtaining relevant information of high quality. In the final stage of study development, these include review of protocol-specified study objectives and design, and review of procedures planned for capturing high-quality data and for reporting to the DMC. At analyses during the trial, these include careful review of data completeness and accuracy to assist in early detection and resolution of evolving problems.
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