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