2017 BreakingtheMoldClinicalTrialsDa

• (Williams & Oliva, 2017) ⇒ T Williams, and A Oliva. (2017). “Breaking the Mold: Clinical Trials Data As RDF.” In: Proceedings of the PhUSE Annual Conference.

Subject Headings: CDISC SDTM, Clinical Trial Data Standard, Clinical Trials Ontology, Clinical Trials Data Exchange.

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• http://scholar.google.com/scholar?q=%222017%22+Breaking+the+Mold%3A+Clinical+Trials+Data+As+RDF

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Abstract

After more than a decade since the implementation of CDISC SDTM as the standard for clinical trials data exchange, our industry continues to struggle with significant implementation challenges:

• [ a ] standards non-conformance resulting in a high incidence of rejection criteria for submissions (1).
• [ b ] Costs converting between versions.
• [ c ] Limitations of the two-dimensional format and lack of intrinsic metadata.
• [ d ] Challenges linking to other standards and data.

This paper outlines the philosophy, ontology, and methods adopted by the PhUSE project "Clinical Trials Data as RDF". By modeling to the data instead of to a specific standard, Resource Description Framework (RDF) supports a future-proof, multi-dimensional data store for clinical trials data while enabling strong compliance to past, present, and future submission standards. Linked Data is uniquely positioned to bring together multiple standards including SDTM, CDISC Terminology, WHO Drug, MedDRA, and others. High-quality, standards-conformant, validated SDTM domains can be created using SPARQL rules (SPIN).

References

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	Author	volume	Date Value	title	type	journal	titleUrl	doi	note	year
2017 BreakingtheMoldClinicalTrialsDa	T Williams A Oliva			Breaking the Mold: Clinical Trials Data As RDF						2017