1. Why the Industry Needs an EDM Reference Model
DIA Webinar: EDM Reference Model
Why the Industry Needs an EDM Reference Model
DIA Document and Records Management SIAC

2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
Change to: In addition to DIA’s continued presence in North America, Europe, and Japan, DIA also serves the following regions:
India (remove italics from Mumbai, India, October 16-18, 2006)
Middle East (7th Annual Middle East Regulatory Conference, Dubai, UNITED ARAB EMIRATES, November 14-16, 2006)
China
Remove Central and Eastern Europe since it’s referenced at the top.
Latin America 2

3. Speakers and Panel Members
Domain
Michelle Herrera Foster
Quality (CMC)
Ken VanLuvanee
Nonclinical
John Aitken
Clinical
Lisa Mulcahy
Trial Master File
Sean Healey
Administrative
Jim Averback
Cross-domain Features

4. Charter / Scope / Deliverables
Project Chartered February 2007
Initial scope limited to documents intended for submission to regulatory agencies
Deliverables From Charter:
Guidelines and a preliminary model for a technology neutral electronic document management repository
Applicable to creation and storage of documents
Support the (e-)CTD and be open to future expansion
Identify a minimum set of metadata

5. We Are Not Suggesting
That this hasn’t been done already, many times by many companies
Many solutions do exist
Vendors have created solutions
Companies have created their own solutions
Like the “X” Files….solutions are “out there” but not always accessible , compatible and/or interoperable, i.e., content is not easily exchanged between systems

6. Beyond EDM – the TMF Reference Model
Project Chartered March 2009
Scope: The full TMF with all applicable functional areas involved in clinical research. Not to include the preclinical, non-clinical, and chemical, manufacturing & controls functional areas.
Deliverables From Charter:
Definition of the TMF content by dividing into zones
Defining standard nomenclature of the contents
Defining options for TMF structure
Integrate the TMF into EDM reference Model and definition of minimum metadata, including definition of new metadata, required for TMF contents

7. TMF Reference Model Global Reach
European and USA co-chairs
Pharma, Biotech, CRO, Health Service, IT companies
Involving many functions: Clinical, document management, business development, regulatory, quality and compliance, data management, statistics, medical writing, pharmacovigilance, supplies and archiving
Involving other Associations – QA, GCP, Clinical, Archiving, Data Management, Regulatory, other DIA SIACs
Involving Regulatory Agencies
The Need:
People from any discipline that are passionate about the TMF and want to contribute to a global standard model

8. Why a Common Model? Economics / Technology
Healthcare, Government, e-Health initiatives
Integration of content from pharmaceuticals and healthcare
Industry Mergers & Acquisitions
Integration of content from different companies
Externalization of Business Processes
Exchange of content between companies
Standards & Emerging Solutions
CDISC, HL7 driving toward “computable” content
CTD / e-CTD / NeeS / RPS

9. Why a Common Model? Industry
Content taxonomy, i.e., the organization of content, is not a competitive advantage or a secret

10. Impact of Document Management
Discovery to Post-Marketed Support
Multitude of information sources
“All roads lead to documents”
EDM = expensive proposition if we constantly “re-invent the wheel”
Lack of “throw away” models
We have an opportunity to simplify and standardize EDM
Save money, time and resources
Leverage existing and emerging standards
Ensure long term “findability” and Records Management

11. A Reference Model
Not a requirement, but it does make life simpler and it is not hard if we work together

12. Freedom to Exchange Content
Documents have multiple authors, contributors, and reviewers and increasingly from multiple companies
Documents may be used in more than one way, by more than one organization
Multiple submissions
Possibly by multiple companies
Multiple locations within a submission
Due diligence for company or compound valuation

13. Efficiency and Cost-Savings
Standardization for Contract Services Providers:
Contract Research, Labs and Manufacturing
Increased collaboration within and across industry
Greater need than ever to share documents
Compound in- and out-licensing
Joint ventures
Mergers and acquisitions
Joint compound development and marketing

14. Submission-Ready Documents
Documents can be organized and stored in ways that ease consumption and use
Common, needed metadata can be associated with each document type
Eases searching and inclusion in metadata-heavy formats
Can assist Regulatory in initial assembly of commonly used submission formats
…and can be extended for uncommon formats, as well

15. Adoption of Regulatory Standards
Transition to eCTD
The model provides recommendations on granularity for life cycle management
RPS, NeeS and other CTD-based submission standards
The model provides a stable core on which other standards can be layered
Speed to adoption of new standards is facilitated by having a common model across the industry

16. Thank You to the Working Group Members
Antoinette Azevedo
Bonnie A Neuhardt
Bridget Brayman
Craig L Barrila
Donald Palmer
Edsel David
Eric Makovsky
Erick Gaussens
Harv Martens
JD Liddil
Kimberly Ann Somermeyer
Karen Roy
Laura Sherman
Lisa Grim
Peggy Zorn
Sean Healey
Shuyen Huang
Sophie Daniel
Susan Landis
Steve Scribner
Thomas Altenwerth
Tom Moore

17. Special Thank You
The EDM Reference Model would not exist today were it not for the foresight and leadership of:
Nancie Celini (CAB)
John Aitken (Gilead Sciences)
Dimitri Stamatiadis (Merck-Sorono)

18. Contact Persons Speaker Domain email Michelle Herrera Foster
Quality (CMC)
Ken VanLuvanee
Nonclinical
John Aitken
Clinical
Lisa Mulcahy
Trial Master File
Sean Healey
Administrative
Jim Averback
Cross-domain Features
Leander Fontaine
Labeling

19. How We Measure Success And Your Involvement! Your feedback
Ongoing improvements
Track record of implementation
And Your Involvement!