CDISC SHARE, a Global, Cloud-based Resource of Machine-Readable CDISC Standards for Clinical and Translational Research

The Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit standards development organization that creates consensus-based standards for clinical and translational research. Several of these standards are now required by regulators for electronic submissions of regulated clinical trials’ data and by government funding agencies. These standards are free and open, available for download on the CDISC Website as PDFs. While these documents are human readable, they are not amenable to ready use by electronic systems. CDISC launched the CDISC Shared Health And Research Electronic library (SHARE) to provide the standards metadata in machine-readable formats to facilitate the automated management and implementation of the standards. This paper describes how CDISC SHARE’S standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis; and its role as a central resource providing information systems with metadata that drives process automation including study setup and data pipelining.

• Publication year

  2018

• Venue

  AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science

• Publication date

  2018-05-18

• Fields of study

  Medicine, Computer Science

• Identifiers
  PMID 29888049PMCID 5961771
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Specific toxicologist/pathologist responses for Standard for Exchange of Nonclinical Data (SEND)

  2017cited by this paper
• A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM

  2017cited by this paper
• Visualizing and Validating Metadata Traceability within the CDISC Standards

  2017cited by this paper
• Automated Import of Clinical Data from HL7 Messages into OpenClinica and tranSMART Using Mirth Connect

  2016cited by this paper
• 1,500 scientists lift the lid on reproducibility

  2016cited by this paper
• Current applications and future directions for the CDISC Operational Data Model standard: A methodological review

  2016cited by this paper
• Why Most Clinical Research Is Not Useful

  2016cited by this paper
• BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciences

  2016cited by this paper
• A Global, Neutral Platform for Sharing Trial Data.

  2016cited by this paper
• Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation

  2016cited by this paper
• The Process of Installing REDCap, a Web Based Database Supporting Biomedical Research

  2014cited by this paper
• Implementing interoperable provenance in biomedical research

  2014cited by this paper
• Possible Combinations of Electronic Data Capture and Randomization Systems

  2014cited by this paper
• The Use of Research Electronic Data Capture (REDCap) Software to Create a Database of Librarian-Mediated Literature Searches

  2014cited by this paper
• Procurement of shared data instruments for Research Electronic Data Capture (REDCap)

  2013cited by this paper
• BioPortal: enhanced functionality via new Web services from the National Center for Biomedical Ontology to access and use ontologies in software applications

  2011cited by this paper
• Clinical Data Interchange Standards Consortium

  2010cited by this paper
• Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support

  2009cited by this paper
• Documentation

  2006cited by this paper
• CmapTools: A Knowledge Modeling and Sharing Environment

  2004cited by this paper
• Drug approvals taking too long?

  2002cited by this paper
• NATIONAL CANCER INSTITUTE

  1993cited by this paper
• Center for the Study of Drug Development

  1988cited by this paper

• The systematic assessment of completeness of public metadata accompanying omics studies in the Gene Expression Omnibus data repository

  2025cites this paper
• Perceptual and technical barriers in sharing and formatting metadata accompanying omics studies

  2025cites this paper
• The development and analysis of a Japanese modern comprehensive clinical data management training program

  2024cites this paper
• Data standards in drug discovery: a long way to go.

  2024cites this paper
• Perceptual and technical barriers in sharing and formatting metadata accompanying omics studies

  2023cites this paper
• Investigating the Secondary Use of Clinical Research Data: Protocol for a Mixed Methods Study

  2022cites this paper
• Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports

  2022cites this paper
• The systematic assessment of completeness of public metadata accompanying omics studies in the Gene Expression Omnibus

  2021cites this paper
• The Collaborative Metadata Repository (CoMetaR) Web App: Quantitative and Qualitative Usability Evaluation

  2021cites this paper
• Introducing an Ontology-Driven Pipeline for the Identification of Common Data Elements.

  2020cites this paper
• A Linked Data Model and Hypermedia API for CDISC SHARE 2 . 0

  2019cites this paper
• Mouse model systems of autism spectrum disorder: Replicability and informatics signature

  2019cites this paper
• Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms using a CDISC ODM API

  2018cites this paper
• Visualizing and Validating Metadata Traceability within the CDISC Standards

  2017cites this paper