Clinical Data Interchange Standards Consortium (CDISC) Standards and Their Implementation in a Clinical Data Management System

The Submission Data Standards Group of the Clinical Data Interchange Standards Consortium (CDISC) has developed metadata standards for electronic submissions. These standards have been defined to guide the organization, content, and form of submission datasets for the 12 safety-related domains speci...

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Bibliographic Details
Published in:Drug information journal 2001, Vol.35 (3), p.853-862
Main Authors: Wood, Frederick E., Fitzsimmons, Michael J.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical trial. Drug monitoring
Consortia
Data management
Data structures
Demographic variables
Demography
Domains
General pharmacology
Medical sciences
Metadata
Modelling
Pharmacology. Drug treatments
Regulatory agencies
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Description
Summary:The Submission Data Standards Group of the Clinical Data Interchange Standards Consortium (CDISC) has developed metadata standards for electronic submissions. These standards have been defined to guide the organization, content, and form of submission datasets for the 12 safety-related domains specified in the Food and Drug Administration (FDA) guidance documents for electronic submissions. Although the CDISC model provides consistency for variable names and data structures, it is also flexible, allowing for differences in what data sponsors collect and how they collect them. This paper is divided into two major parts. The first includes the background of CDISC and an overview of the CDISC model. The scope of the current CDISC effort, the elements of the metadata model, and the variables common to all domains are discussed, using the “Demographics” domain as an example. The second part uses the “Physical Exam” domain to illustrate the model's flexibility, as well as to show the practical application of the model in a clinical data management system. The benefits and disadvantages of several modeling approaches are discussed. While much of the focus is on modeling the “Physical Exam” domain in Oracle Clinical, the ultimate solution described herein could be implemented in any clinical data management system. CONCLUSIONS
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286150103500323