IngentaConnect The Submission Data File System: automating the creation of CDISC...

Authors: Bloom, Marcus¹; Edwards, David¹

Source: Pharmaceutical Programming, Volume 2, Number 1, August 2009 , pp. 41-52(12)

Abstract:

From its inception the SDF System was designed to tackle many of the difficulties that have plagued statistical programming ever since the first programs were developed to analyze clinical trial data. The system scope includes the following areas:

•Automating front-end and back-end data security

•Providing rapid access to raw and derived datasets to all sites within the organization

•Implementing large scale systems design and software engineering principles in the clinical trials programming domain to reduce the software development effort required for each statistical analysis

•Modeling the complex relationships inherent within clinical data to provide sophisticated impact analysis tools with the capability to manage and cascade change

•Implementing an object-oriented (OO) approach to the definition and reuse of clinical data standards

•Improving review and quality control processes by coupling the specification of a program together with it's source code to create one logical entity

•Reducing the validation burden (through large-scale reuse) while at the same time increasing overall quality

Keywords: APPLICATION DEVELOPMENT; CDISC STANDARDS; DATA TRANSFORMATION ENGINE; SAS CODE GENERATION; PROGRAM DEPENDENCY MANAGEMENT

Document Type: Research article

DOI: 10.1179/175709208X334687

Affiliations: 1: Amgen Inc., Thousand Oaks, CA, USA

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The Submission Data File System: automating the creation of CDISC SDTM and ADaM datasets