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OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda

OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda. January 6, 2014 9:00 – 10:00 AM PST. Agenda. Roll Call. Meeting Etiquette. Announce your name prior to making comments or suggestions Keep your phone on mute when not speaking (#6)

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OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda

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  1. OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda January 6, 2014 9:00 – 10:00 AM PST

  2. Agenda

  3. Roll Call

  4. Meeting Etiquette • Announce your name prior to making comments or suggestions • Keep your phone on mute when not speaking (#6) • Do not put your phone on hold • Hang up and dial in again when finished with your other call • Hold = Elevator Music = very frustrated speakers and participants • Meetings will be recorded and posted • Another reason to keep your phone on mute when not speaking! • Use the join.me “Chat” feature for questions / comments / Votes • We will follow Robert’s Rules of Order From eTMF Std TC to Participants: Hi everyone: remember to keep your phone on mute  NOTE: This meeting is being recorded and minutes will be posted on TC page after the meeting

  5. Oasis Overview TC Process & Administration OASIS eTMF TC Inaugural Meeting16 December 2013

  6. TC Process Overview • TC Process is created by OASIS Board, carried out by TC Adminstration • Job of TC Administration • Support activities of OASIS members • Turn TC Process guidelines into practical rules • Communicate procedures & best practices to TCs • Represent TC interests to Board • Improve tools & support for members • Recommend improvements to process itself OASIS Presentation to eTMF TC

  7. Work Product Lifecycle OASIS Presentation to eTMF TC

  8. Work Product Lifecycle • Your work products will progress through the following stages for a Standards Track Work Product: • Working draft (no official standing) • Committee Specification Draft • Committee Specification Public Review Draft • Committee Specification • Candidate OASIS Standard • OASIS Standard • Approved Errata OASIS Presentation to eTMF TC

  9. TC Process Overview Some other things to know: • TCs run on Roberts Rules of Order, including its requirements for quorum • To vote, you must maintain meeting attendance OASIS Presentation to eTMF TC

  10. Outreach Subcommittee • Status • Timeline • In parallel with other Tech work from charter

  11. 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)

  12. Content Model and Data Model Content Model • Content Model = eTMF Domain Classification • Conceptual model • Supports vocabulary, relationships • Includes core metatadata, 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

  13. 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 BioMedical Ontology, 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

  14. 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)

  15. 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.

  16. Draft Agenda: Next Meeting • Roll call • Reports • Outreach, Technical • OASIS process discussion – Part II, Chet Ensign • Tech Discussion: Content Classification System (Charter item 2, p.2) • New business

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