OASIS

Electronic Trial Master File Standard

Technical Committee

Meeting Agenda

May 5, 2014

9:00 – 10:30 AM PDT

Agenda Topic Presenter

9:00-9:05 Call to Order & Roll Call Jennifer Alpert

9:05-9:10 Approval of Minutes All

9:10-9:15 Secretary Duties All

2

9:15-9:45 Metadata Vocabulary Layer Overview Jennifer

9:45-9:50 New Business All

9:50-10:00 Next Meeting Agenda / Date Jennifer

Roll Call Last Name Company Voting Status Present?Jenni fer Alpert Pa lchak, Co-Chair CareLex Member/VoterAl iaa Badr CareLex Member/VoterOleks iy (Alex) Pa l inkash CareLex Member/VoterBeau Grignon Forte Research Systems MemberTroy Jacobson Forte Research Systems Member/VoterMead Walker, HL7 Lia ison Health Level Seven (HL7) Member/ 2nd mtngLou Chappuie Individual Member/VoterLisa Mulcahy Individual MemberSharon Elcombe Mayo Cl inic Member/VoterRobert Gehrke Mayo Cl inic MemberTom Johnson Mayo Cl inic MemberSharon Ames NextDocs Member/2

nd mtng

Prabhat Vatsa l NextDocs Member/1st

mtngRobin Cover OASIS OASIS Staff ContactChet Ens ign OASIS OASIS Staff ContactRich Lustig Oracle Member/VoterMichael Agard Paragon Solutions Member/VoterChris McSpiri tt Paragon Solutions Member/VoterJamie O'Keefe Paragon Solutions Member/VoterFran Ross Paragon Solutions Member/VoterPeter McNaney Phlexglobal Ltd. Member/ 2nd mtngPeter Al terman SAFE-BioPharma Assn Member/VoterCatherine Schmidt Sterl ingBio Member/VoterAyrat Sadreev SureCl inica l Member/ 1st mtngZack Schmidt, Co-Chair SureCl inica l Member/VoterTrish Whetzel SureCl inica l Member/VoterStephen Scribner EMC ObserverLaura Hi l ty Forte Research Systems ObserverTony O'Hare Forte Research Systems ObserverDee Schur OASIS Observer

Meeting Etiquette • Announce your name prior to making comments or suggestions

• Keep your phone on mute when not speaking

• 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

• We will follow Robert’s Rules of Order

NOTE: This meeting is being recorded and will be posted on the project Wiki page after the

meeting

From eTMF Std TC to Participants: Hi everyone: remember to keep your phone on mute

4

Phase II Architecture Discussion

© CareLex 2014

Application Architecture Context

Display Labels

Presentation Layer

Fields Forms

Application Services Layer

RDF/XML Metadata Vocab

Digital Signature Bus. Process Mgt

Persistent Data Storage Interoperable Data Exchange

Data Services Layer

© CareLex 2014

Phase I Work

Phase II Work

Presentation Layer = What User Sees

Display Labels

Presentation Layer

• Draw on existing, controlled vocabularies that are maintained,

curated, easily referenced, including CDISC (BRIDG), Dublin

Core, HL7, NCI

• Use industry-accepted terms: CareLex, TMF RM

• Allow organization-specific terms

Vocabulary Layer Concepts

‘Standard based on

standards’ approach:

• Interoperability is not

possible without a

standards-based

vocabulary ex: HTML interoperable vocabulary

for web viewing:

• National Cancer Institute Enterprise Vocabulary Services

is the standard for metadata vocabulary development,

publication and curation in health sciences

Why A Standards-based Vocabulary?

Safari Browser Firefox Browser

• Provides terminology content, tools, and services to accurately code, analyze and share cancer and biomedical research, clinical and public health information

• Rigorous assessment of metadata terms and definitions in a broader clinical trials and health research context to assure both applicability as well as mitigate conflicts with other domain vocabularies. (i.e. mole, mole, mole)

• Follows US Federal and international coding standards, supporting increasingly international nature of clinical trials

NCI Enterprise Vocabulary Services

NCI Controlled Vocabularies

NCI is the global repository for health sciences metadata vocabularies

• “Concept-based (one code for one meaning; may have

multiple terms or synonyms).

• Human (text) and computer-readable definitions.

• Logical parent-child hierarchies, with poly-hierarchy

• Unique, permanent, meaningless (machine readable )codes or

identifiers

• Concept history mechanism to track data over time

• Ontological structure (formal knowledge representation

as a set of concepts and the relationships among them) allowing

more and better use of data”

Source: NCI Enterprise Vocabulary Services

NCI EVS Vocabulary Standards

• Establish machine-readable, classification scheme with unique, machine-readable codes

• Terms must have unambiguous meaning

• Ontology with data properties, annotation properties, content items (Essential to interoperability)

• Support Major Version.Minor Version numbering policies

• Support 256 character limit on file paths imposed by some applications

• Support W3C Semantic Web standards

• Draw on NCIt-published terms (Dublin Core, BRIDG, HL7, NCIt)

• Support industry terms (CareLex, TMF RM)

• Publish eTMF Standard terms at NCIt

eTMF Standard Metadata Vocab Elements

• EVERY company has unique needs

• Flexibility to add or edit

– Org-specific metadata terms

– Org-specific content items

• Published rules (draft) for metadata editing essential to

interoperability!

• Easy, reliable intra- and inter-company data exchange

Addressing Organization Needs

Flexibility with Interoperability

© CareLex 2014

eTMF Standard Backend Architecture Components

eTMF Metadata Vocabulary

RDF/XML Code

SOP List Kickoff Meeting Material IRB-IEC Filenote Statistics Communication

BRIDG

NCI CareLex

TMF RM

Dublin Core HL7

Display Labels: End User Views

List of SOPs Current During Trial Kickoff Meeting Material General IRB-IEC Filenote Relevant Communications (stats)

SOPs Boot up Meeting Material Institutional Review Bd Notes Stats Correspondence

Digital Content

Digital Content

Sponsor CRO

View

able

by u

sers

Invisib

le to

use

rs

• Standards-based set of controlled metadata vocabulary is required

for interoperability

• Display labels allow use of ANY terms to describe a taxonomy while

supporting interoperability (i.e. TMF RM)

• Rules ensure interoperability, while allowing editing of terms and

taxonomy

• Public, standards-based controlled vocabulary accessible to all on

NCI Thesaurus

• Additional Oasis eTMF TC terms can be added via NCIt

• Proposal: Oasis eTMF Standard TC adopt NCI as the primary

standards-based vocabulary repository

Metadata Vocab Layer Summary

• Draft Agenda for May 19:

– Roll call

– Working Draft Spec discussion

– Metadata Vocabulary Layer

• Hierarchy (Categories, Subcategories, Content items)

• Editing Rules

– New business

New Business & Next Meeting