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

doi:10.3233/978-1-61499-951-5-125

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 proceeding › Chapter

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 language	English (US)
Title of host publication	Improving Usability, Safety and Patient Outcomes with Health Information Technology
Subtitle of host publication	From Research to Practice
Editors	Alex Mu-Hsing Kuo, Andre Kushniruk, Francis Lau, Elizabeth M. Borycki, Gerry Bliss, Helen Monkman, Abdul Vahabpour Roudsari, John A. Bartle-Clar, Karen L. Courtney
Publisher	IOS Press
Pages	125-132
Number of pages	8
ISBN (Electronic)	9781614999508
DOIs	https://doi.org/10.3233/978-1-61499-951-5-125
State	Published - 2019
Externally published	Yes

Publication series

Name	Studies in Health Technology and Informatics
Volume	257
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

Access to Document

10.3233/978-1-61499-951-5-125

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

Development of data validation rules for therapeutic area standard data elements in four mental health domains to improve the quality of FDA submissions. / Garza, Maryam; Seker, Emel; Zozus, Meredith.
Improving Usability, Safety and Patient Outcomes with Health Information Technology: From Research to Practice. ed. / Alex Mu-Hsing Kuo; Andre Kushniruk; Francis Lau; Elizabeth M. Borycki; Gerry Bliss; Helen Monkman; Abdul Vahabpour Roudsari; John A. Bartle-Clar; Karen L. Courtney. IOS Press, 2019. p. 125-132 (Studies in Health Technology and Informatics; Vol. 257).

Research output: Chapter in Book/Report/Conference proceeding › Chapter

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 AM-H Kuo, A Kushniruk, F Lau, EM Borycki, G Bliss, H Monkman, AV Roudsari, JA Bartle-Clar & KL Courtney (eds), Improving Usability, Safety and Patient Outcomes with Health Information Technology: From Research to Practice. Studies in Health Technology and Informatics, vol. 257, IOS Press, pp. 125-132. https://doi.org/10.3233/978-1-61499-951-5-125

Garza M, Seker E, Zozus M. Development of data validation rules for therapeutic area standard data elements in four mental health domains to improve the quality of FDA submissions. In Kuo AMH, Kushniruk A, Lau F, Borycki EM, Bliss G, Monkman H, Roudsari AV, Bartle-Clar JA, Courtney KL, editors, Improving Usability, Safety and Patient Outcomes with Health Information Technology: From Research to Practice. IOS Press. 2019. p. 125-132. (Studies in Health Technology and Informatics). doi: 10.3233/978-1-61499-951-5-125

Garza, Maryam ; Seker, Emel ; Zozus, Meredith. / Development of data validation rules for therapeutic area standard data elements in four mental health domains to improve the quality of FDA submissions. Improving Usability, Safety and Patient Outcomes with Health Information Technology: From Research to Practice. editor / Alex Mu-Hsing Kuo ; Andre Kushniruk ; Francis Lau ; Elizabeth M. Borycki ; Gerry Bliss ; Helen Monkman ; Abdul Vahabpour Roudsari ; John A. Bartle-Clar ; Karen L. Courtney. IOS Press, 2019. pp. 125-132 (Studies in Health Technology and Informatics).

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

Abstract

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Keywords

ASJC Scopus subject areas

Access to Document

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