OASIS Electronic Trial Master File Standard

Technical Committee

Meeting AgendaJanuary 6, 2014

9:00 – 10:00 AM PST

AgendaTopic Presenter

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

Group

9:10-9:20 TC Process and Administration Chet Ensign

2

9:20-9:30 Outreach Subcommittee Report Jennifer Alpert9:30-9:55 New Business Zack Schmidt

9:55-10:00 Next meeting agenda / Date All

Name Company Voting Status Present?Jennifer Alpert Palchak CareLex Voter y

Aliaa Badr CareLex Voter yOleksiy (Alex) Palinkash CareLex Voter nTroy Jacobson Forte Research Voter yLou Chappuie Individual Voter yLisa Mulcahy Individual Non-Voter nRobert Gehrke Mayo Clinic Voter n

Michael Agard Paragon Solutions Non-Voter yChristopher McSpiritt Paragon Solutions Non-Voter y

Jamie O’Keefe Paragon Solutions Non-Voter nFran Ross Paragon Solutions Non-Voter YPeter Alterman SAFE-BioPharma Voter nCatherine Schmidt SterlingBio Voter yZack Schmidt SureClinical Voter yTrish Whetzel, PhD SureClinical Non-Voter yPeter Junge Beijing Sursen Observer nLaura Hilty Forte Research Observer yTony O’Hare Forte Research Observer nEldin Rammell Rammell Consulting Observer nRich Lustig Oracle Observer yRobin Cover OASIS staff Non-Voter nChet Ensign OASIS staff Non-Voter y

Roll Call

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 OrderNOTE: 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

OASIS eTMF TC Inaugural Meeting16 December 2013

Oasis OverviewTC Process & Administration

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

OASIS Presentation to eTMF TC 7

Work Product Lifecycle

OASIS Presentation to eTMF TC 8

Work Product LifecycleYour work products will progress through

the following stages for a Standards Track Work Product:

1. Working draft (no official standing) 2. Committee Specification Draft3. Committee Specification Public Review Draft 4. Committee Specification 5. Candidate OASIS Standard 6. OASIS Standard7. Approved Errata

OASIS Presentation to eTMF TC 9

TC Process OverviewSome other things to know:• TCs run on Roberts Rules of Order,

including its requirements for quorum• To vote, you must maintain meeting

attendance

• Status• Timeline• In parallel with other Tech work from charter

Outreach Subcommittee

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

• 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 ModelContent Model

Data Model

Metadata

StudyDigital Content

eTMF Domain Classification

eTMF Instance for Study

• 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)

• HL7 Model 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

Proposed use of Ontology for eTMF Domain

• 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

• 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 is outlined in Section 2, Pg 4.

Resources - Content Model, Arch

• 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