Abstract
The development of analysis-ready data for clinical trials is a complicated process that is often problematic. Not only are the data inherently complex, but also analytical and reporting requirements tend to evolve over a period of time. Additional difficulties arise because of the number of individuals working with the data and the varied uses of the data. A new approach is described that greatly facilitates the creation, maintenance, and documentation of these data. Results are encouraging and include contributing to high quality and improved productivity.
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Glaser, A. An Improved Process for the Creation, Maintenance, and Documentation of Analysis-ready Data. Ther Innov Regul Sci 40, 331–335 (2006). https://doi.org/10.1177/009286150604000311
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DOI: https://doi.org/10.1177/009286150604000311