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Core Tech Architecture Discussion

Core Tech Architecture Discussion. Key Foundational Layers Classification, Vocab, Web Stds Classification Content Model (Taxonomy) Web Std Tech Requirements W3C, cloud, online, offline Digital Signing - PKI x.509 Business Process model support Export / Import format

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Core Tech Architecture Discussion

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  1. Core Tech Architecture Discussion Key Foundational Layers • Classification, Vocab, Web Stds • Classification • Content Model (Taxonomy) • Web Std Tech Requirements • W3C, cloud, online, offline • Digital Signing - PKI x.509 • Business Process model support • Export / Import format • (XML, RDF/XML)

  2. Content Model and Data Model Content Model • Content Model = eTMF Domain Classification • Conceptual model • Supports vocabulary, relationships • Includes core metadata, domain metadata • W3C RDF/XML • Data Model = eTMF Instance for a Study • Instance of digital content for a single study • Includes content model in use • Pointers to content resources • W3C XML eTMF Domain Classification Metadata Data Model eTMF Instance for Study Study Digital Content

  3. Proposed use of Ontology for eTMF Domain • Ontology’s are used to define conceptual models for a domain • Related Domains using ontology and W3C RDF/XML to define their domain model: • CDISC/FDA PhUSE project – Interoperable data standards initiative • NCI Thesaurus – Published semantic concepts, vocabulary in National Center for BioMedicalOntology (NCBO) • HL7Model Interchange Format — RIM, data types, and HL7 vocabulary • Propose use of ontology and W3C RDF/XML to represent eTMF domain • eTMF Content Model can be edited, validated with free open source editor, Protégé • eTMF Data Model can be edited, validated with XML editors

  4. Proposed eTMF Data Model • Data model is used to define an instance of the content model • Data model defines a single clinical trial study / archive • Contains content model in use, metadata in use, links to content resources • Can be used online / offline • Supports viewing of data model in web browser • Universally exchangeable, interoperable • W3C XML format proposed (V1.0 encoding = UTF-8)

  5. Resources - Content Model, Arch • Use of Semantic technologies for representation of interoperable content models in Health Sciences: • HL7 Semantic Tech: http://www.genomeweb.com/informatics/qa-io-informatics-charles-mead-efforts-adopt-semantic-web-translational-medicine • CDISC / FDA PhUSE: http://www.prweb.com/releases/PhUSECDISC/SemanticTechnology/prweb11065477.htm • NCI Thesaurus: http://purl.bioontology.org/ontology/NCIT -- CareLex – eTMF Content Model: http://purl.bioontology.org/ontology/CareLex/ • Proposed OASIS eTMF Standard Architecture: • http://carelex.org/downloads/CareLex Content Model Spec – V1.03 • Architecture isoutlined in Section 2, Pg 4.

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