Welcome to the Webinar Understanding The OASIS eTMF Specification… · Welcome to the Webinar "Understanding The OASIS eTMF Specification: An Overview For TMF RM Members” MODERATOR:

Welcome to the Webinar

"Understanding The OASIS eTMF

Specification: An Overview

For TMF RM Members”

MODERATOR: Dee Schur – OASIS [email protected]

SPEAKERS:

Jennifer Alpert Palchak, OASIS eTMF Technical Committee Co-Chair and CEO, CareLex

Fran Ross, OASIS eTMF Technical Committee Member and Associate Director, Paragon Solutions

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

• Leading global standards organization

• 600 organizations and over 5,000 members worldwide

• Global document management vendors such as

Alfresco, EMC, Fujitsu, IBM, Microsoft, Oracle and many

others are contributors and members of OASIS

OASIS Open

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?

• Create A Technical Standard Based on Standards

• Use Open Systems Approach – Operating system independent

– Software application independent

– Computer language independent

• Remain Open Source & Independent Resource

• 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

• Seamless exchange of digital data/content between

various collaborator systems – Sponsor, Sponsor Partners, Auditors, Regulatory agencies

• Define formatting for eTMF documents and records

export and exchange between electronic systems

• Facilitate quality and compliance

• Maintain search, reporting, archival, and audit trail

data of clinical trial documents

Goal of OASIS eTMF Standard

• A standard based upon standards for M2M interoperability (aka Data Portability)

• Detailed specification for application developers that serve the clinical trials industry

• “Technical road map for data portability within systems”

– Content model, data model, content model instance

– Machine code in RDF/XML

– Controlled vocabulary with unique identifying codes for ontology (essential to interoperability!)

What IS the OASIS eTMF Standard?

• Not the introduction of a new TMF model for content

organization

• Not a set of rules dictating the document names as

viewed by users – Is market driven and will be determined by Vendor applications

• Not restrictive regarding media types (document format) – Is based on IANA standard = 1,080 MT at present – http://www.iana.org/assignments/media-types/media-types.xhtml

• Not restrictive in system approach – Is conducive to off line, networked and cloud-based systems

What OASIS eTMF Standard Is Not

.JPEG .GIF

Where Does TMF RM Fit?

CRO 3 System

eTMF Standard RDF/XML

Code

TMF en Español

eTMF Standard RDF/XML

Code

TMF RM adapted

CRO 2 System

Sponsor System

eTMF Standard RDF/XML

Code

TMF RM terms

CRO 1 System

eTMF Standard RDF/XML

Code

TMF RM terms

OASIS eTMF Standard Specification offers flexibility for TMF RM to be supported on a standards-based platform (mapping may be required)

• Two Valuable Purposes: – TMF RM taxonomy used in and by clinical opps (‘end user’)

– eTMF Standard codes, taxonomy and ontology used by vendors

for software development to ensure interoperability/data

portability (does not dictate ‘end user’ views)

• OASIS eTMF Standard supports TMF RM taxonomy

while allowing software applications (vendors) to

tailor their products to their clinical customer needs

eTMF Standard/TMF RM Alignment

• 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?

• 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 OWL file with RDF/XML code

• Metadata Vocabulary Spreadsheet

eTMF Committee Specification Draft

OASIS Presentation to eTMF TC 13

OASIS Work Product Lifecycle

eTMF TC:

45 days

(6/24 – 8/8)

eTMF TC

start: 12/13

• Developing a Standard is an evolving process

• Need for on-going collaboration between TMF

RM and OASIS eTMF Standard (e.g. mapping)

• 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

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

How To Participate

• In reviewing the OASIS eTMF Specification metadata

vocab:

– Are terms used accurately mapped to TMF RM?

– If not, what needs to be fixed?

– Anything with terms that would create errors or

compliance issues?

– Any terms missing? If so, which one(s) and how do

they relate to other terms?

– Are there terms for documents which are not

contained in a TMF?

Questions for Non-Technical Reviewers

• Focus on Goal develop standard for interoperability

of eTMF

• Provide solutions, not criticisms

– Poor: “Why is 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

1. Subscribe to the comment list by sending a blank email message to:[email protected]

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: [email protected]

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

“ZIP distribution file (complete):

For your convenience, OASIS provides a complete package of the

prose document and related files in a ZIP distribution file. You can

download the ZIP file here:

http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/etmf-v1.0-

csprd01.zip”

OASIS Links: Zip File Is Easiest

Questions