Summary

Data that has a level of confidence, validity, and reliability is crucial to the success of a clinical trial and to bringing the investigational medicinal product (IMP) to market. Throughout the course of a clinical trial, the project team, site staff, and sponsor representatives work diligently to ensure that all data is “cleaned” and captured accurately in the study databases. Such efforts may be sufficient to ensure scientifically sound data, but could more be done to improve the quality?

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