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De-identifying Clinical Trial Data

In: Principles and Practice of Clinical Trials

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  • Jimmy Le

    (National Eye Institute)

Abstract

Conducting clinical trials involves collecting detailed health information about participants. Privacy of individual participants is important and must be protected especially when individual participant data are shared broadly. De-identification refers to the process of removing or obscuring identifiable information in data. The resulting “de-identified” clinical trial dataset minimizes the risk of unintended disclosure of the identity of participants and information about them. This chapter presents different types of identifiers that may be present in clinical trial data and outlines two commonly used approaches to de-identifying data that are provided in the Privacy Rule of the United States Health Insurance Portability and Accountability Act as examples.

Suggested Citation

  • Jimmy Le, 2022. "De-identifying Clinical Trial Data," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 107, pages 2115-2136, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_191
    DOI: 10.1007/978-3-319-52636-2_191
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