Abstract
The main components of a typical modern study data system are described, together with a discussion of associated workflows and the options for deployment, such as PaaS (platform as a Service) and SaaS (software as a service), and their implications for data management. A series of recommendations are made about how to create a study specific system, by developing a specification from the study protocol within a multidisciplinary framework, obtaining formal approval of that specification, building prototypes, and then carrying out a detailed and systematic validation of the system before releasing it for use. The use of data standards is described and strongly encouraged, and the need for distinct development, test, and production environments is discussed. Longer term aspects of system management are then considered, including change management of the study data system and preparing the data for analysis, and managing data in the long term.
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Canham, S. (2020). Design and Development of the Study Data System. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_36-1
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DOI: https://doi.org/10.1007/978-3-319-52677-5_36-1
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