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Abstract

Activities performed in clinical monitoring and data management should ultimately lead to a final clinical database that is complete, accurate, free from implausible data, and substantiated by the source data at investigator sites and on case report forms (CRFs). This constitutes the basis for statistical analysis, which ultimately leads to the final study report.

Typically, clinical trials are described in a chronological manner: monitoring, data management, then statistics. Procedures for all clinical trial processes can be optimized, however, if not only trial statisticians but also clinical research associates (CRAs) responsible for monitoring the sites and data managers have a clear understanding of the critical variables of the study and the requirements of the clinical study report, right from the start. Applying an inverted perspective on the sequence of clinical processes leads to interesting insights and offers improvement potential.

Keywords

Monitoring Data management Statistics Process improvement Critical variables Clinical study report Clinical trials

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Getting Better Clinical Trial Data: An Inverted Viewpoint

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