FAIR Principles and Clinical Research Data

The FAIR principles state that data should be findable, accessible, interoperable, and reusable [@wilkinson2016fair]. FAIR does not mean open without restriction. Clinical research data often contain personal or sensitive health information and must be governed carefully. A dataset can be FAIR within a controlled-access environment if metadata are clear, access procedures are defined, and reuse conditions are documented. Findable means that data and metadata can be discovered. This may involve a repository record, persistent identifier, title, keywords, creators, and study description. Accessible means that authorized users can obtain data under defined conditions. Interoperable means that data use standard formats, vocabularies, and structures where possible. Reusable means that documentation is sufficient for appropriate future use.

Metadata standards such as DataCite support dataset citation and discovery [@datacite2024metadata]. Clinical datasets may also require domain standards such as CDISC, depending on sponsor, regulatory, or collaboration requirements [@cdisc2024cdash; @cdisc2024odm].