1. OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda January 6, 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 Group 9:10-9:20 TC Process and Administration Chet Ensign 2 9:20-9:30 Outreach Subcommittee ReportJennifer Alpert 9:30-9:55 New Business Zack Schmidt 9:55-10:00 Next meeting agenda / Date All

3. NameCompanyVoting StatusPresent? Jennifer Alpert Palchak CareLex Votery Aliaa BadrCareLexVotery Oleksiy (Alex) PalinkashCareLexVotern Troy JacobsonForte ResearchVotery Lou ChappuieIndividualVotery Lisa MulcahyIndividualNon-Votern Robert GehrkeMayo ClinicVotern Michael AgardParagon SolutionsNon-Votery Christopher McSpirittParagon SolutionsNon-Votery Jamie O’KeefeParagon SolutionsNon-Votern Fran RossParagon SolutionsNon-VoterY Peter AltermanSAFE-BioPharmaVotern Catherine SchmidtSterlingBioVotery Zack SchmidtSureClinicalVotery Trish Whetzel, PhDSureClinicalNon-Votery Peter JungeBeijing SursenObservern Laura HiltyForte ResearchObservery Tony O’HareForte ResearchObservern Eldin RammellRammell ConsultingObservern Rich LustigOracleObservery Robin CoverOASIS staffNon-Votern Chet EnsignOASIS staffNon-Votery 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. OASIS eTMF TC Inaugural Meeting 16 December 2013 Oasis Overview TC Process & Administration

6. OASIS Presentation to eTMF TC 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

7. OASIS Presentation to eTMF TC 7 Work Product Lifecycle

8. OASIS Presentation to eTMF TC 8 Work Product Lifecycle Your work products will progress through the following stages for a Standards Track Work Product: 1. Working draft (no official standing) 2. Committee Specification Draft 3. Committee Specification Public Review Draft 4. Committee Specification 5. Candidate OASIS Standard 6. OASIS Standard 7. Approved Errata

9. 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

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

11. 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) Core Tech Architecture Discussion

12. 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 Content Model and Data Model Content Model Data Model Metadata Study Digital Content eTMF Domain Classification eTMF Instance for Study

13. 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 initiativeCDISC/FDA PhUSE NCI Thesaurus – Published semantic concepts, vocabulary in (National Center for BioMedical Ontology, NCBO)NCI Thesaurus HL7 Model Interchange Format — RIM, data types, and HL7 vocabularyHL7 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 Proposed use of Ontology for eTMF Domain

14. 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) Proposed eTMF Data Model

15. 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 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 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/http://purl.bioontology.org/ontology/CareLex Proposed OASIS eTMF Standard Architecture: –http://carelex.org/downloads/ CareLex Content Model Spec – V1.03http://carelex.org/downloads/ Architecture is outlined in Section 2, Pg 4. Resources - Content Model, Arch

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