February 17, 2014 9:00 – 10:00 AM PST

1. OASIS Electronic Trial Master File Standard Technical Committee Metadata Component Content Model Component February 17, 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. Outreach Subcommittee • Status – New Members: • Outreach Activity summary / Milestones • Joined: Tom Johnson, Sharon Elcombe /Mayo Clinic • In Progress: Shire • Deliverable – Summary Industry outreach / Comments report

6. Tech Presentation Content Classification Layer • Metadata component Recap • Address comments regarding: • Document Versioning, Country, Sponsor • Content Model component Recap / RDF/XML • Address comments regarding Content Model versioning • Summarize Content Classification Layer • Discussion

7. Metadata Component - Recap • Metadata Component: • Metadata (‘Tags’) • Characterizes content • Allows users to precisely search for information, create reports, share data online • Use of standards-based terms is critical for interoperability between systems

8. Metadata Component - Recap Metadata Component Example • Each Content Type contains metadata that describes it: Metadata Tagging:

9. Core Metadata – Document Version Numbering • Based on comments re: Doc Version support, anew metadata term is proposed: Document Version (applies to eTMF Document or Content Item) • Based on NCI/CDISC/FDA/HL7/BRIDG term definitions: • Per NCI/NIH/BRIDG: a ‘Representation of a particular edition or snapshot of a document as it exists at a particular point in time.’ • NCI Code C93484, NCI Code C93816 • Follows industry standard ‘Major.Minor’ numbering: • Major =1.0, Minor = 1.1 • Document Version management is an application-specific / implementation specific task

10. Core Metadata – Document Version Numbering Implementation Example – Version History for Doc/Content Item* • Minor • Version • Metadata change for a content item • Any change to doc/content item’s metadata values or attributes represent minor change • Major • Version • Content Item change • New Content Item • Any change to doc/content item is major change *Example only. Application-dependent.

11. Core Metadata – Document Version Numbering Policy Document Version number text formatting In the eTMF Standard, the document version text values follow the same formatting that is familiar and commonly implemented in software and in other health science standards: Major Version.Minor Version. Version numbering text are integer values separated by a period, without leading zeros. There can be a new Major version every time the document/content item changes. There can be a new Minor version every time the metadata changes. Version Numbering Policies (based on NCI/CDISC/FDA/BRIDG def: C93816) Within eTMF archives, document / content item version management shall be application specific to provide for application flexibility. However, for consistent content item exchange, version number text formatting should be implemented using eTMF document version numbering policies: Each document Major version number is an integer starting at '1' and incrementing by 1. The first instance or original document should always be valued as '1'. The version number value must be incremented by one when a document is replaced, but can also be incremented more often to meet application specific requirements. Different versions of the same document belong to the same Content Type group. The document Minor version number would be an integer starting at ‘0' and incrementing by 1. The first instance of an original document with no minor version should always be valued as ‘1.0’, where ‘0‘ indicates that no minor version exists. Documents with a change to the metadata values would require a minor version. The first minor version for a 1.0 document would be indicated as 1.1. Successive changes to any of the document’s metadata would increment the Minor version by 1, for example 1.2 indicates major version 1 and minor version 2. The Minor version number value must be incremented by one when a document’s metadata is changed, but can also be incremented more often to meet application specific requirements.

12. Core Metadata Terms Created By From last meeting – Created By is published by NCI and has the following definition. Aliaa investigated CDISC BRIDG, has not discovered any conflict by CDISC BRIDG on the use of Created By. *For additional info, see Spec, Appendix 8

13. Core Metadata Terms Note: Core metadata terms should be included for each content item. Terms with required Data values = * Proposed New Core MD Term: *For additional info, see Spec, Appendix 8

14. Core Metadata Terms, Continued *For additional info, see Spec, Appendix 8

15. eTMF Domain Metadata Terms Note: Study ID , Country and Clinical Study Sponsor metadata terms should be included for each content item in the eTMF Domain. Required Terms are marked * All other terms assigned to content types based on the published domain content model. For example ‘Site ID’ is assigned to content types within the ‘Site Management’ category. See published eTMF content model for details. All other terms are optional. Additional eTMF Domain Metadata terms may be added as needed in ‘Phase 2’ of the eTMF TC project Proposed New Core eTMF MD Term: *For additional info, see Spec, Appendix 8

16. General Metadata Note: General Metadata is not required, but is obtained from published standards organizations such as Dublin Core, DICOM, and other standards organizations

17. Content Models • Recap on Content Models • What and Why • Content Model Format / Exchange • How Used • Content Model Versioning under W3C OWL/RDF/XML

18. Content Models Recap: What and Why Whatare Content Models (CM): • Represent content classifications, relationships, metadata in a semantic web taxonomy or ‘Ontology’ • CM’s are created using the W3C OWL2 language and RDF/XML Why • Semantic web allows seamless sharing, linking of data across networks • Industry moving to Semantic web: • CDISC/FDA/PHuse project • HL7, NIH/NCI, many more

19. Content Models Recap: Content Model Format / Exchange Content Model Format / Exchange • Content Model Profile for the eTMF domain represented as W3C OWL2 classes • Allows for easy editing, sharing by anyone • Allows for limited validation • Content Model Instances expressed as W3C RDF/XML (eTMF study specific) • RDF/XML used as the syntax for content model exchange • Exchange CM’s using Serialized RDF/XML or RDF/XML as a file with .owl extension: • etmf.owl • Exchange Protocol: No specific protocol is specified by RDF/XML, nor is one required for content model exchange. • Any protocol which supports exchange of RDF/XML files or serialized data such as W3C http/s, REST, SOAP, RPS, CMIS, etc. • Application / implementation- specific *Per W3C

20. Content Models Recap: Content Model Format / Naming Example W3C RDF/XML Content Model File Snippet: XML V1.0 CM File Example • W3C RDF/XML used as the syntax for content model representation and exchange • Contains RDF and OWL in XML • Contains reference to Content Model Profilefor eTMF • Contains Content Model Instance for Study CM File Naming • The .OWLfilename extension is used for RDF/XML files. Example: filename.owl • Allowable filename characters: Filenames for content model exchange shall be similar to IETF URL naming as follows: • Alphanumeric characters • Special characters: • Only ‘– ’ (hyphen) may be used to ensure future compatibility RDF/OWL

21. Content Models Recap: How Used Content Model Profile for eTMF Domain -Core Classes How Used • For the eTMF Domain, a core standard set of categories (categories, subcategories, content types) and core metadata will be published: • Content Model Profile for eTMF Domain • Core set of categories is included with all Content Models (users can show/hide categories, but not delete them) • Enables interoperability • Content models easily downloadable Organization Specific • Includes Content Model Profile for eTMF Domain • Additionally, Orgs can create/add their own categories • Provides flexibility • Share, exchange CM’s through RDF/XML format • Share with published URL Org-specific Content Model

22. Content Models CM Versioning OWL/RDF/XML Two types of Versioning: Content Item Versioning, Content Model Versioning: Content Model Versioning • Versioning of Content Models is supported through W3C OWL Versioning Policies • W3C OWL supports granular level of versioning • Version management is an application-specific task • owl:versionInfo provides a hook suitable for use by versioning systems Content Model Version numbering text: • Major.Minornumbering • Major = Content Model Profile Vn # • Minor = Org Specific Version of CM. May be enhanced with org specific, application specific numbering within W3C OWL versioning policies • Use with owl:versionInfoin RDF/XML for content model categories, annotation and data properties • <owl:versionInfo>1.0.0</owl:versionInfo> Content Model Profile for eTMF Domain -Core Classes V1.0 Org-specific Content Model V1.1 Sub-Minor Number = Org-specific versioning – app specific V1.1.company.com.123 Minornumber = Content Model Profile for eTMF, Minor change to metadata, annotation props, data props Major Number = Content Model Profile for eTMF Domain – Published Version # Sub-MinorNumber = Org-specific/app specific

23. Summary: Content Classification Layer Standards-based Architecture: • Content Classification • Defined Rules, Policies for Naming, Numbering • Metadata (‘Tags’) • Rules to Characterize content • Controlled vocab • Content Models • WC3 RDF/XML