Long-Term Management of Data and Secondary Use

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.