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 TopicPresenter 9:00-9:05 Call to Order & Roll Call Zack Schmidt 9:05-9:10 Approval of Minutes https://www.oasis- open.org/committees/documents.php?wg_abbrev=etmf https://www.oasis- open.org/committees/documents.php?wg_abbrev=etmf All 9:10-9:15 OASIS policy review: member/observer roles Chet Ensign 2 9:15-9:25 Tech pres – Metadata, Content Model Components; Esig/Dsig Intro Z. Schmidt 9:30-9:50 Tech Discussion – Content Classification Layer All 9:50-9:55 Outreach Committee / New BusinessJennifer Alpert All 9:55-10:00 Next meeting agenda / Date Z. Schmidt

3. NameCompanyVoting StatusPresent? Jennifer Alpert PalchakCareLexMember/VoterY Aliaa BadrCareLexMember/VoterY Oleksiy (Alex) PalinkashCareLexMember/VoterY Troy JacobsonForte ResearchMember/VoterY Mead WalkerHL7Member/HL7 LiasonY Lou ChappuieIndividualMember/VoterY Lisa MulcahyIndividualMember/N Sharon ElcombeMayo ClinicMember/ (2 nd mtg )Y Robert GehrkeMayo ClinicMember/(np last mtg)N Tom JohnsonMayo ClinicMember/(1st mtg )N Rich LustigOracleMember/VoterY Michael AgardParagon SolutionsMember/VoterY Christopher McSpirittParagon SolutionsMember/VoterN Jamie O’KeefeParagon SolutionsMember/(np last 2 mtgs)N Fran RossParagon SolutionsMember/VoterY Eldin RammellRammell ConsultingMember/(1st mtg )Y Peter AltermanSAFE-BioPharmaMember/Voter (Leave till 3-3)N Catherine SchmidtSterlingBioMember/VoterY Zack SchmidtSureClinicalMember/VoterY Trish WhetzelSureClinicalMember/VoterN Peter JungeBeijing SursenObserverN Steve ScribnerEMCObserverY Laura HiltyForte ResearchObserverN Tony O’HareForte ResearchObserverN Chet EnsignOASISStaffY 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 NOTE: This meeting is being recorded and minutes will be posted on TC page after the meeting From eTMF Std TC to Participants: Hi everyone: remember to keep your phone on mute 4

5. 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 Tech Presentation

6. –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 Metadata Component - Recap

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

8. Term Sourcing Concepts: Terms adopted by standards bodies should be used first in eTMF model Primary Term Sources for eTMF Metadata: –Internet Standards Dev Orgs : W3C, IETF, ISO, etc. »Required for interoperability of machine code –NIH NCIthesaurus: Term database for FDA, CDISC, HL7, other orgs »Required for interoperability of clinical / health sciences data Secondary, Tertiary Term Sources for eTMF Metadata: Medical & Published Standards metadata: Dicom (med imaging); Dublin Core Industry sources – widely used terms in enterprise content mgmt software, TMF RM Metadata – Term Sources - Recap *Spec, Table 6, p21

9. Based on comments re: Doc Version support, a new 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 C93816C93484C93816 –Follows industry standard ‘Major.Minor’ numbering: »Major =1.0, Minor = 1.1 Document Version management is an application- specific / implementation specific task Core Metadata – Document Version Numbering

10. Core Metadata – Document Version Numbering Policy Document Version number text formatting Major Version.Minor Version Version numbering text are integer values separated by a period, without leading zeros. 1. 0 Major version – Changes to document/content items. Minor version – Changes to any metadata for the document/content item. Version Numbering Policies (based on NCI/CDISC/FDA/BRIDG def: C93816) C93816

11. Core Metadata – Document Version Numbering VersionCreated ByModified ByDateDescription 3.03.0 DBROWN2/16/2014 8:30PMDocument modification 2.02.0 JLENO2/16/2014 7:30PMDocument modification 1.11.1 RJONES2/15/2014 5:30PMMetadata only modification 1.01.0 SSMITH2/14/2014 4:30PMOriginal Item Major Version Content Item change New Content Item Any change to doc/content item is major change Minor Version Metadata change for a content item Any change to doc/content item’s metadata values or attributes represent minor change Implementation Example – Version History for Doc/Content Item* * Example only. Application-dependent.

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

13. Core Metadata Terms TermDefinitionSource File Properties * Created The date and time at which the resource is created. For a digital file, this need not match a file-system creation time. For a freshly created resource, it should be close to that time. Later file transfer, copying, etc., may make the file-system time arbitrarily different. NIH/NCI * ModifiedThe date and time the resource was last modified. NIH/NCI * Content Identifier The unique identifier for a content item, such as a document, image, or other media in a specified context. (Document name.) NIH/NCI * URI The unique uniform resource Identifier or path (URI) for a content item such as a document, image, or other media in a specified context. NIH/NCI * Format Content Item File Format, e.g., PDF, JPG, GIF, XLS, DOC, DOCX, XLSX, PPT, PPTX. It uses a filename extension as the format value. NIH/NCI *Document Version Per NCI/NIH/BRIDG, a Document version is a ‘Representation of a particular edition or snapshot of a document as it exists at a particular point in time.’ The term document version applies to documents as well as to content items. Synonym : Content Item Version (document or any other electronic file in eTMF)document version NIH/NCI Basic Audit Trail * Created ByIndicates the username of the person who brought the item into existence. NIH/NCI * Modified ByIndicates the username of the person who changed an item. NIH/NCI Classification * Content Type NameThe name of the Content Type such as 'CV.' A Content Type is a reusable collection of metadata, workflow, behavior, and other settings for a category of items in electronic content material. NIH/NCI Note: Core metadata terms should be included for each content item. Required Terms - must have data values = * *For additional info, see Spec, Appendix 8 Proposed Adopted New Core MD Term:

14. Core Metadata Terms, Continued *For additional info, see Spec, Appendix 8 TermDefinitionSource Business Process Metadata (includes Digital Signatures) Date Date of task or event, or date in the context of document or Content Type. Date can be different from date created. NIH/NCI Process A sequence or flow of activities in an organization with the objective of carrying out work. Source: BPMN V2.0 Spec (4). Tasks are atomic activities. They are included within a Process. NIH/NCI Task A single activity that has occurred within a business process. Generally, an end-user, an application, or both will perform the Task. Concept derives from BPMN V2.0. Example task values are: Submitted, Approved, Reviewed, Signed, etc., indicating that a task has been completed. Each task is date stamped and captured in a single record of the business process metadata history log. NIH/NCI Source Where the content item is from or its origin. Example values: Import, Scan, Fax, email, system, and other. NIH/NCI Person The full name of the person who performed the workflow action (e.g., approved or submitted a document) or the person to whom this document is linked. NIH/NCI Person Role The role of the person who is responsible for or linked to a content item, such as Principal Investigator, Sub-Investigator, Study Coordinator, Sponsor Project Manager, CRO Project Manager, or Data Manager. NIH/NCI Subject Identifier Subject Identifier is a unique sequence of characters used to identify, name, or characterize the study subject individual in a clinical trial study. NIH/NCI * Organization The full name of the Organization linked to the resource. NIH/NCI Organization Role Denotes the role of the organization, which is responsible for or linked to the Content Item. Values include Sponsor, Site, CRO, and Vendor. NIH/NCI UsernameThe account name used by a person to access a computer system (used for system generated tasks). NIH/NCI Digital Signature Extra data embedded in a document or metadata linked to a document. It identifies and authenticates the signer of a document using public-key encryption. May be a URI or path to digital signature resource or certificate. NIH/NCI Digital Signature StatusSpecifies whether a document or content item has been digitally signed. If no signature is required, status = null. Values: Signed, Not Signed, Null NIH/NCI

15. eTMF Domain Metadata Terms *For additional info, see Spec, Appendix 8 TermDefinitionSource eTMF Domain Metadata *Study ID Organization specific value, assigned and defined by the study sponsor. A sequence of characters used to identify, name, or characterize the study. NIH/NCI CountryName of country using ISO 3166-1 alpha-3 country codes- Example: USA.NIH/NCI *Clinical Study Sponsor ‘An entity that is responsible for the initiation, management, and/or financing of a clinical study; organization that initiates a study and that specifies the Study ID’ (check on NCI definition C48355) NIH/NCI Site IDA unique symbol that establishes the identity of the study site.NIH/NCI Credential Professional credential of Person for study - MD, RN, PhD or other for Person linked to a content item / document; EX: MD, RN, PhD, MS, MA, BA, MBA NIH/NCI Visit NumberThe numerical identifier of the visit.NIH/NCI 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 Adopted New Required eTMF MD Term:

16. General Metadata TermDefinitionCode General Metadata DescriptionAn account of the resource or content item.Dublin Core LocationA spatial region or named place.Dublin Core TitleA name given to the resource or content item.Dublin Core TypeThe nature or genre of the resource or content item.Dublin Core Note: General Metadata is not required, but is obtained from published standards organizations such as Dublin Core, DICOM, and other standards organizations

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

18. What are 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, search of data across domains Possibility to link to other semantic models in future like CDISC, HL7, etc Industry moving to Semantic web: –CDISC/FDA/PHuse project –HL7, NIH/NCI, many more Content Models Recap: What and Why

19. Content Model Format / Exchange Content Model Profile for the eTMF domain represented as W3C OWL2 classesW3C OWL2 –Allows for easy editing, sharing by anyone –Allows for limited validation Content Model Instances expressed as W3C RDF/XML (eTMF study specific)W3C RDF/XML 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 Content Models Recap : Content Model Format / Exchange *Per W3C

20. 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 Profile for eTMF Contains Content Model Instance for Study CM File Naming The.OWL filename extension is used for RDF/XML files. Example: etmf.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 Content Models Recap : Content Model Format ; Naming Example W3C RDF/XML Content Model File Snippet: XML V1.0 RDF/OWL

21. 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 Content Models Recap: How Used Study ID Site Management CVFDCentral FilesProtocol Content Model Profile for eTMF Domain -Core Classes Study ID Site Management CVFDCentral FilesProtocol MyCorp SubCategory Org-specific Content Model

22. Content Model Versioning Versioning of Content Models is supported through W3C OWL Versioning PoliciesVersioning 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.Minor numbering –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:versionInfo in RDF/XML for content model categories, annotation and data properties – 1.0.0 Content Models CM Versioning OWL/RDF/XML Study ID Site Management CVFDCentral FilesProtocol Study ID Site Management CVFDCentral FilesProtocol MyCorp SubCategory Org-specific Content Model Major Number = Content Model Profile for eTMF Domain – Published Version # Minor number = Content Model Profile for eTMF, Minor change to metadata, annotation props, data props Content Model Profile for eTMF Domain -Core Classes V1.0 V1.1 V1.1.company.com.123 Sub-Minor Number = Org-specific versioning – app specific Sub-Minor Number = Org-specific/app specific Two types of Versioning: Content Item Versioning, Content Model Versioning:

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

24. Status – New Members: –Outreach Activity summary / Milestones –Joined: Tom Johnson, Sharon Elcombe /Mayo Clinic In Progress: Shire –Active Prospects –Deliverable – Summary Industry outreach / Comments report Outreach Subcommittee

25. 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)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.