De-identifying Clinical Trial Data

Jimmy Le ()
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Jimmy Le: National Eye Institute

Chapter 107 in Principles and Practice of Clinical Trials, 2022, pp 2115-2136 from Springer

Abstract: 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.

Keywords: Data de-identification; Good clinical practice; Metadata; Individual Participant Data; Data sharing; HIPAA; Data use agreements; Clinical trials (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_191

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