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ERIC Number: ED550850
Record Type: Non-Journal
Publication Date: 2013
Pages: 143
Abstractor: As Provided
Reference Count: N/A
ISBN: 978-1-2679-6684-1
Information Model for Reusability in Clinical Trial Documentation
Bahl, Bhanu
ProQuest LLC, Ph.D. Dissertation, University of Medicine and Dentistry of New Jersey
In clinical research, New Drug Application (NDA) to health agencies requires generation of a large number of documents throughout the clinical development life cycle, many of which are also submitted to public databases and external partners. Current processes to assemble the information, author, review and approve the clinical research documents, and publish them into submissions formats are complex and expensive. Additionally, due to disjointed processes and tools to produce the documents, there are increased risks related to the consistency and quality of content used across documents. In the absence of a standard methodology or enabling technology for content collection & aggregation the information is buried in documents and document management systems. Clinical documents are matrixed under a hierarchical and rigid document--centric structure that does not follow any content specific standard. In order to achieve higher levels of efficiencies, consistency and quality of information across the clinical planning and documentation processes, I have developed a topic based information design to facilitate reuse of the clinical trial content. The downstream goal is to deliver a structured library of clinical research-specific content for intelligent reuse that can be leveraged by the wider enterprise for supporting hypothesis based research. Storing the information in a contextual or intelligent form will facilitate content retrieval when needed. Appropriate metadata tagging of the content, alignment with standards that govern submission will be proposed. Methods for implementation and evaluation of benefits were Agile and lean six sigma respectively. The information design establishes reuse across clinical trial submission documents. I have found a 100% reuse of information from Extended Synopsis to Protocol document and at least 30% reuse from Protocol to Clinical Study Report. This reuse was realized after the information has been broken down or "chunked" up in Darwin Information Typing Architecture (DITA) topics and appropriate metadata is subscribed to facilitate the content retrieval. DITA is used to define the topic-sizing of information and the maps to generate the document outputs. The formatting or presentation of output will be handled by Extensible Stylesheet Language Transformations (XSLT) style sheets. Categories of reuse like conditional reuse; substitution reuse, component reuse and referential reuse will be discussed. Organizational impacts in terms of new roles definition for moving to a structured content based information management approach is presented--namely Information Architect; Content Designers; Metadata Stewards & Content Stewards besides the Author and Reviewer roles. [The dissertation citations contained here are published with the permission of ProQuest LLC. Further reproduction is prohibited without permission. Copies of dissertations may be obtained by Telephone (800) 1-800-521-0600. Web page:]
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Publication Type: Dissertations/Theses - Doctoral Dissertations
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A