Clinical Data Interchange Standards Consortium (CDISC) Standards and Their Implementation in a Clinical Data Management
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0092-861512001 Copyright 0 2001 Drug Information Association Inc.
CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM (CDISC) STANDARDS AND THEIR IMPLEMENTATION IN A CLINICAL DATA MANAGEMENT SYSTEM FREDERICK E. WOOD,JR, PHD The F’rocter & Gamble Company, Health Care Research Center, Mason, Ohio
MICHAELJ. FITZSIMMONS, MA Aventis Pharmaceuticals Inc., Bridgewater, New Jersey
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? 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. Key Words: CDISC; Data standards; FDA guidance; Electronic submissions; Oracle Clinical
INTRODUCTION
mission, review, and archiving of clinical data. In order to manage its broad mission THE cLIMcAL DATA Interchange efficiently, CDISC established a number of dards Consortium, or CDISC, was founded working groups, each with a specific task in 1998. The goal of CDISC is to develop or area of focus. One of these groups, the data standards that could be adopted by reSubmissions Data Standards Group, has been viewing agencies, sponsors, and vendors to working to develop standards to facilitate the facilitate the acquisition, interchange, subsubmission and review of clinical data. The Submission Data Standards Group was esReprint Dr. Frederick E. Wood, The F’rocter g, tablished in late 1999, and consists of repreGamble company, 8700 Mason-Montgomery Road, sentatives from more than 15 pharmaceutical Mason, OH 45040-9462. and biotechnology companies, contract re853
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Frederick E. Wood, Jr. and Michael J. Fitzsimmons
search organizations, and technology vendors. This paper focuses on the Submission Metadata Model (1) developed by this group. Since the FDA is currently the only regulatory authority that requires data to be submitted, it has been considered the primary cust
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