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A metadata schema for data objects in clinical research.

Steve Canham1, Christian Ohmann2

  • 1European Clinical Research Infrastructure Network (ECRIN), Kings Avenue, Redhill, RH16QH, UK.

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Summary
This summary is machine-generated.

A consistent metadata scheme is crucial for maximizing the utility of clinical research data repositories. This proposal extends the DataCite standard to enhance transparency and data sharing in clinical studies.

Keywords:
Data repositoriesData sharingECRINEuropean Clinical Research Infrastructure NetworkIdentifiersMetadataStandardsTransparency

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Area of Science:

  • Clinical research informatics
  • Data science in healthcare

Background:

  • Growing need for transparency in clinical research.
  • Development of diverse repositories for clinical study data objects.
  • Necessity for a standardized metadata scheme to utilize data repositories effectively.

Purpose of the Study:

  • To identify metadata requirements for effective clinical research data sharing.
  • To explore issues related to persistent identifiers for studies and data objects.
  • To propose a metadata scheme for clinical research data.

Main Methods:

  • Described relevant data objects and their storage.
  • Identified metadata requirements for data sharing.
  • Explored persistent identifier issues for studies and data objects.

Main Results:

  • Proposed a metadata scheme based on the DataCite standard with clinical research extensions.
  • The scheme includes study identification, data object characteristics, and access information.
  • Detailed the components of the proposed metadata scheme.

Conclusions:

  • The proposed metadata schema extends a widely accepted standard to address unmet needs in clinical research data management.
  • It fills a gap not covered by existing standards like CDISC and BRIDG.
  • The schema can be integrated with other data structuring initiatives in clinical research.