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Welcome to the
"Understanding the OASIS eTMF
Specification for Non-Technical Professionals”
Webinar
MODERATOR: Dee Schur – OASIS dee.schur@oasis-open.org
SPEAKERS:
Jennifer Alpert Palchak, OASIS eTMF Technical Committee Co-Chair and CEO, CareLex
Sharon Ames, OASIS eTMF Technical Committee Member and Director of Enterprise Solutions, NextDocs
• Leading global standards organization
• 600 organizations and over 5,000 members worldwide
• Global document management vendors are contributors
and members
• OASIS eTMF TC is open to all: contact join@oasis-
open.org for more information
OASIS Open
CareLex, EMC, Forte Research Systems, Health Level 7, Mayo Clinic,
NextDocs, Oracle, Paragon Solutions, Phlexglobal Ltd., Safe Biopharma
Association, SterlingBio, SureClinical, University of Michigan
• Open processes: open to public observation & input
Technical Committee Members
Oracle:
“Interoperability reduces or eliminates the problems of
islands of automation. It enables business processes to
flow from one application to another. Interoperability
enables one system to work with another, in near real-time
fashion, to share critical business information.”
Why eTMF Interoperability?
• Clinical trials are transitioning from
paper to electronic systems:
Opportunity: Increased productivity, time
savings
Problem: No Interoperability = organizations
cannot share clinical TMF information easily
due to the lack of data standards
Problem Being Solved?
• Proprietary, non-standardized vendor solutions – Limit data management approach
– Prevent seamless data exchange
• Data standards allow information to be easily shared, regardless of the eTMF system
• Standards offer flexibility, productivity and new capabilities
Why is This Important?
• Seamless exchange of digital records (content)
between collaborator systems – Sponsor, Partners, Auditors, Regulatory agencies
• Define formatting for eTMF records export and
exchange between electronic systems
• Facilitate quality and compliance
• Efficient search, report, and audit of clinical trial data
and their associated records
• Reduce trial times
Goal of OASIS eTMF Standard
• Create A Standard Based on Standards (Technical)
• Use Open Systems Approach – Operating system independent
– Software application independent
– Computer language independent
• Remain Open Source & Independent
• EVERY company Has Unique Needs…
• Allow for Flexibility to Add or Edit – Org-specific metadata terms
– Org-specific content items
• Published rules (draft) for metadata editing [essential!]
OASIS eTMF TC Guiding Principles
Application Architecture Overview
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
Regulatory Guidelines:
• EMA
• FDA
• ICH
Technology Standards:
• Business Process Modeling
• CMIS
• Digital Certificate Signing
(PKI x.509)
Vocabulary References:
• BRIDG (CDISC)
• CareLex
• Dublin Core
• HL7
• NCI Thesaurus
• TMF Reference Model
• Cross references to TMF RM
and HL7 RPS (future)
A Standard Based On Standards
Specification Inputs
• 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
Controlled Vocabulary Overview
Safari Browser Firefox Browser
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
Enabling Communication Regardless of Display Labels
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 System CRO System
View
able
by u
sers
Invisib
le to
use
rs
• Vendors – Greatest immediate impact. Standard to implement company-
specific solutions for clinical trials industry that incorporate data portability (interoperability)
• Sponsors – Data portability between multiple CROs/Vendors who implement
Oasis eTMF Standard
• CROs – Data portability between CRO/Sponsors who use standard;
could use same system for work with all sponsors in spite of vendor
• Sites – Very limited impact. Vendor-designed ‘permissions’ would enable
usage.
How Will This Impact Me?
OASIS Presentation to eTMF TC 14
OASIS Work Product Timeline
eTMF TC:
45 days
(6/24 – 8/8)
eTMF TC
start: 12/13
• Specification Draft document – 40 page document with details regarding:
• Background on standard, Core Technology Architecture, Content
Classification System, Web Standard Technology, Conformance
requirements, Versioning, Rules, etc. (incomplete list!)
• eTMF RDF/XML machine code file
• Metadata Vocabulary Spreadsheet
eTMF Committee Specification Draft
Join the OASIS eTMF Standard Technical Committee: https://www.oasis-open.org/join
View & comment on eTMF Committee Specification Draft
(Zip file): http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/etmf-v1.0-csprd01.zip
Comments may be submitted by any person via the
OASIS TC Comment URL: https://www.oasis-open.org/committees/comments/index.php?wg_abbrev=etmf
AUGUST 8 DEADLINE!
How To Participate
1. Subscribe to the comment list by sending a blank email message to:etmf-comment-subscribe@lists.oasis-open.org
2. Confirm your subscription request by replying to the confirmation email message you will receive from OASIS. Your subscription will not be complete until you respond to this message.
3. Watch your inbox for a Welcome message indicating that your subscription is now active.
4. Send your comment to: etmf-comment@lists.oasis-open.org
5. http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/etmf-v1.0-csprd01-COMMENT-TAGS.html
6. Note: If you are a member of the OASIS Electronic Trial Master File (eTMF) Standard TC, please post to the TC mailing list directly.
How To Submit A Comment
• Focus on Goal develop standard for interoperability
of eTMF
• Provide solutions, not criticisms
– Poor: “Why is only an FDA specific regulation cited?”
– Useful: “Add EMA and CFDA regulations…., which are
applicable here.”
• Be Specific
– Poor: “Use of specific field ‘Digital Signature’ is not understood.”
Useful: “Section 2, replace ‘Enterprise’ with ‘Electronic’”
• Focus on Your Area of Expertise
Impactful Comments
• Developing a Standard is an evolving process
• Need for on-going collaboration and input from
diverse industry groups and experts
• Future versions of Standard will be generated
• Education and Implementation Training will be
essential upon Standard release
• Support changing industry needs on-going
Future Implications
Sharon Ames Member, OASIS eTMF Standard TC
Director of Enterprise Solutions, NextDocs
Jennifer Alpert Palchak
Co-chair, OASIS eTMF Standard TC
CEO, CareLex
Questions
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