Abstract
The final, clinical study report (CSR) of a clinical trial arguably may be the most important aspect of a clinical trial. However, the basis for estimating the time required to prepare a CSR (ie, the work rate) has been based on time-honored estimates. The following metrics analysis, based on recent experience at a large pharmaceutical firm, may provide an objective measure for planning CSR development. The metrics for this analysis come from a small sampling of 10 clinical study reports from 10 medical writers. Word count and elapsed time metrics were collected using features built into MS Word. The statistical relationships of data were checked to verify their significance (their reliability) in making an accurate prediction. Based on the sample data collected and analyzed, meaningful metrics need to be constantly obtained, maintained, and analyzed to produce timely CSRs.
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