OASIS Electronic Trial Master File Standard Technical Committee

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1 OASIS Electronic Trial Master File Standard Technical Committee Content Classification Layer Tech Discussion Preview January 20, :00 10:00 AM PST

2 Agenda Topic Presenter 9:00-9:05 Call to Order & Roll Call Zack Schmidt 9:05-9:10 Approval of Minutes TC Process and Administration (deferred) All Chet Ensign 9:10-9:20 Outreach Subcommittee - All Jennifer Alpert 9:20-9:50 Tech presentation Content Classification Layer Z. Schmidt/Aliaa 9:50-9:55 New Business All 9:55-10:00 Next meeting agenda / Date Z. Schmidt 2

3 Content Classification System Discussion Classification System Components: Classification Categories Taxonomy, hierarchy Metadata ( Tags ) Characterizes content Content Model Published set of classifications, metadata for a domain (e.g., etmf)

4 Classification Categories Component Classification Categories Component Hierarchy of categories Categories, subcategories, content types Classification Categories Hierarchy Defined relationships with rules: Parent-Child All categories, content types required to have unique names and machine codes Each content type is associated with Metadata Properties (includes core and domain-specific) Content items are linked to content types. Unique classification and term codes based on Universal Decimal Classification System (UDC) numbering, widely used in libraries worldwide. Human and machine readable; infinitely expandable Can be described, edited and validated using OWL editor (like open source editor Protégé ) Supports any simple text vocabulary, including TMF Ref Model and other vocabularies W3C OWL2 and RDF/XML supported Study Digital Content

5 Metadata Component Metadata Component Used to tag or index digital content items Core Metadata Example File Properties: Metadata Classes: Core - Comprised of four areas: File Properties, Classification, Audit Trail Business Process Domain-specific -- Metadata for a domain in life sciences such as etmf, finance, legal administration, or others. Uses standards-based terms from groups like NCI Org Specific Metadata that meets organizations needs not standards based General obtained from public standards-based vocabulary terminology resources like dublin core Annotation Properties Metadata about classification categories and metadata: Core, Org-Specific metadata

6 Content Model Component Content Model Component Contains classification hierarchy, metadata in machine readable format:

7 Classification Categories Component Classification Categories Component Classification Categories Hierarchy and Numbering [1]: Classification hierarchy and numbering is based on UDC library numbering standard and XML naming Digital dot notation Designed for human and machine readability Each number is also a unique code for naming and ordering in the hierarchy Primary Categories (PC): Three digit. etmf: Subcategories (SC): Two digit: Content Types (CT): : Two digit: Maximum number of Sub- Category divisions is 5, excluding the 3-digits for the Primary Category [1] Per spec section 2.1.1; 6.0 Hierarchy Numbering/Naming Considerations: Flexible, standards-based approach (W3C XML compliant naming*) Ability to add multiple hierarchy divisions / levels Proposed: 5 divisions = [100*90 5 ) = 5.9x10 11 Content Types Uniqueness of numbers usable as machine code identifiers Machine readable, human readable No sorting issues, no need for leading zeros*, no special chars *Leading zeros in XML syntax are ignored:

8 Classification Categories Component Numbering and Naming Scheme Numbering Primary Categories and Sub-Categories : Category Code number Content Type: Example: Classification Categories Hierarchy, Naming, Numbering Naming Content Type ID Primary Categories and Sub-Categories Simple text-based names Unique name, 64 char limit Abbreviation 16 char limit suggested Compatible with W3C XML naming standards : No special characters : ( ) < >? / %

9 Classification Categories Component Modifying Classification Category Entities General Editing Rules Domain Specific Classifications cannot be deleted > Reserve/Unreserve Modifications allowed to some annotation properties (see spec) Codes (Category Codes, CT Type ID) cannot be generated Organization Specific Classification Category, Content Type Editing Rules* Type Import Terms Generate Code Domain Specific Organization Specific **Annotation metadata Add/Modify Delete/Reserve Yes No No/Yes** Reserve/Unreserve Yes Yes Yes/Yes Delete Classifications can be deleted Modifications allowed for classification metadata, annotations Codes (Category Codes, CT Type ID) can be generated *Spec, Table 6, p21

10 Classification Editing Tool Free, Open Source Protégé (From Stanford University: ) Protégé Editor: -Edit Classification Taxonomy and Metadata Terms -Validate Taxonomy and Term name compliance -Create valid RDF/XML Ontology *Spec, Table 6, p21

11 Classification Categories - Summary Proposed Classification System has following Properties: Based on Naming and Numbering that is W3C XML compliant No special characters: ( ) & / etc. No leading zeros in classification numbers Based on Universal Decimal Classification (UDC) system for content classification: : etmf Domain UDC system used in 170+ countries worldwide; expandable, human and machine readable, sortable Flexible and customizable for organizations, yet interoperable Domain classifications Standardized; Organization-specific classifications Editable Defined set of rules for Editing, modifying Taxonomy Any Organization can Modify/Edit taxonomy using open source editors like Protégé *Spec, Table 6, p21

12 Draft Agenda: Next Meeting Roll call Reports Outreach Tech Discussion: Classification Layer: Core Metadata (Charter item 2, p.2) New business

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