Development of data validation rules for therapeutic area standard data elements in four mental health domains to improve the quality of FDA submissions

Maryam Garza, Emel Seker, Meredith Zozus

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Data standards are now required for many submissions to the United States Food and Drug Administration (FDA). The required standard for submission of clinical data is the Clinical Data Interchange Standards Consortium (CDISC) Submission Data Tabulation Model (SDTM). Currently, 45 business rules and 115 associated validation rules exist for SDTM data. However, such rules have not yet been developed for therapeutic area data standards developed under the last reauthorization of the Prescription Drug User Fee Act (PDUFA V). The objective of this effort was to develop data validation rules for new therapeutic area data standards in four mental health domains, assess the metadata required to associate such rules with standard data elements, and assess the level of data validation possible for therapeutic area data elements.

Original languageEnglish (US)
Title of host publicationImproving Usability, Safety and Patient Outcomes with Health Information Technology
Subtitle of host publicationFrom Research to Practice
EditorsAlex Mu-Hsing Kuo, Andre Kushniruk, Francis Lau, Elizabeth M. Borycki, Gerry Bliss, Helen Monkman, Abdul Vahabpour Roudsari, John A. Bartle-Clar, Karen L. Courtney
PublisherIOS Press
Pages125-132
Number of pages8
ISBN (Electronic)9781614999508
DOIs
StatePublished - Jan 1 2019
Externally publishedYes

Publication series

NameStudies in Health Technology and Informatics
Volume257
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365

Keywords

  • CDISC SDTM
  • data standards
  • regulatory submissions
  • therapeutic area standards
  • validation rules

ASJC Scopus subject areas

  • Biomedical Engineering
  • Health Informatics
  • Health Information Management

Fingerprint Dive into the research topics of 'Development of data validation rules for therapeutic area standard data elements in four mental health domains to improve the quality of FDA submissions'. Together they form a unique fingerprint.

  • Cite this

    Garza, M., Seker, E., & Zozus, M. (2019). Development of data validation rules for therapeutic area standard data elements in four mental health domains to improve the quality of FDA submissions. In A. M-H. Kuo, A. Kushniruk, F. Lau, E. M. Borycki, G. Bliss, H. Monkman, A. V. Roudsari, J. A. Bartle-Clar, & K. L. Courtney (Eds.), Improving Usability, Safety and Patient Outcomes with Health Information Technology: From Research to Practice (pp. 125-132). (Studies in Health Technology and Informatics; Vol. 257). IOS Press. https://doi.org/10.3233/978-1-61499-951-5-125