Long-Term Management of Data and Secondary Use

Steve Canham ()
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Steve Canham: European Clinical Research Infrastructure Network (ECRIN)

Chapter 23 in Principles and Practice of Clinical Trials, 2022, pp 427-456 from Springer

Abstract: Abstract The reasons for retaining data after a study is finished are reviewed. The nature and implications of the legal obligations to keep data are explored, with a brief discussion around each of the main questions that need to be considered. The increased pressure to make individual-level data available to others is then examined. Some of the barriers to such secondary use, or “data sharing,” are described as well as some of the ways data re-use can be anticipated and thus facilitated. Practical issues such as data de-identification and data use agreements are discussed. The importance of promoting data inter-operability using standards and common vocabularies is stressed, followed by a brief discussion about data repositories and the selection of a suitable long-term home for data. Processes and systems to support the secondary re-use of data, from the point of view of a trials unit, are suggested. A recurrent theme is the need to consider and plan the long-term management of data from the very beginning of the study, because plans to store and, especially, to share data may have profound implications for data design and study costs.

Keywords: Data retention; Good clinical practice; Metadata; Secondary use; Data sharing; HIPAA; Data standards; Data repositories; Data use agreements (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_286

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