1. Paul Fenton
CEO Montrium Inc.
Initiative for an eTMF
Exchange Mechanism
from the TMF Reference
Model

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© 2015 DIA, Inc. All rights reserved.

3. What are we trying to solve
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More and more electronic systems are
being used to manage TMF
Most systems use the TMF RM to
organize artifacts
At the end of the study the TMF needs
to be transferred back to the sponsor
This often requires a significant
amount of mapping and manipulation
to be able to import the content
Solution: A transport protocol which
facilitates exchange of eTMF
content…The eTMF Exchange
mechanism

4. The Initiative
A technical sub-committee composed
of sponsors, CROs and vendors was
established
Objective: To define a standardized
and simple mechanism for transfer
of eTMF content
Used existing standards such as eCTD
and CDISC as inspiration
Different approach to OASIS which
would focus on content transfer rather
than real-time interoperability
Work in Progress….
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5. How it works
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Study #
Process Zone
Section
Section
Section
Artifact
Artifact
Content Export XML Inventory

6. Exchange XML Files
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content.xml metadata.xml
+

7. Metadata
The subgroup has defined a minimum number of
metadata as standard:
• Study OID
• SiteNo
• Country
• OrganizationName
• PersonName
• Language
Dublin Core is being used for file attributes
CDISC ODM used to define metadata for audit trail and
electronic signatures
All other metadata is user defined – standard should
accommodate any metadata
Over time more metadata may be standardized
© 2015 DIA, Inc. All rights reserved.

8. Content.xml
Is used to provide a listing of all files included in a
transfer
Usually One file would need to be generated per
transfer – Multiple files may be necessary for
large transfers
The receiving system should be able to read the
XML file and import content and metadata
automatically
Each object in the file is linked to the TMF RM
artifact ID
Each file has a checksum to be able to verify
integrity
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9. Example File – Content.xml
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10. Metadata.xml
Used to establish a metadata standard which
can be referenced from a content.xml file
This file is used to define all non-standard
metadata which could be used for content
Metadata data type and choices can be
defined
Can specify if metadata is mandatory
Ideally each content provider would establish
a clear standard
The content receiver would need to map the
metadata standard to their own standard
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11. Example File – Metadata.xml
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12. How could it be used?
Final eTMF transfer to sponsor from CRO for
archiving
Interim transfer of eTMF content to central
eTMF or other trial management system
Migration of eTMF content following merger
and acquisition
Migration of eTMF content following upgrade
or change of eTMF system
Long term archiving of eTMF content and
associated metadata
© 2015 DIA, Inc. All rights reserved.

13. Secret of Success
Try and keep the mechanism
as flexible and simple as
possible
Ensure that all stakeholders
are involved (sponsors,
CROs, vendors + others)
Ensure direct alignment with
the TMF RM – natural
evolution
Make it easy for vendors to
implement and maintain
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14. Evolution
Additional Metadata would be defined
overtime
eTMF Viewers could be developed to be able
to look at eTMF content without having a
system (XSL)
Additional record management tags could be
introduced i.e. retention periods etc.
Could eventually extend to data not just
documents
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15. Challenges
Work in progress with group of volunteers –
Everyone has a day job
Need to establish governance
Need to get vendors to invest in interfaces to
be able to generate and receive eTMF
Exchange files
Need to define some pilot programs to test
drive the initiative between vendors
© 2015 DIA, Inc. All rights reserved.

16. Conclusion
The TMF RM has been widely adopted by the
industry – we now need to extend this with an
eTMF Exchange mechanism
The mechanism needs to have significant
flexibility in relation to metadata
If vendors adopt this mechanism it will become
much simpler, faster and less expensive to
transfer eTMF content
The eTMF Exchange mechanism will evolve to
allow more information and more standardized
metadata over time
This initiative is the first step in a longer journey….
© 2015 DIA, Inc. All rights reserved.

17. Want to get involved?
Interested in participating?
© 2015 DIA, Inc. All rights reserved.

18. Contact Details
DIA
Paul Fenton
pfenton@montrium.com
www.montrium.com
Twitter: @paulkfenton
North America
507 Place d’Armes
Suite 1050
Montreal (QC) H2Y 2W8
Canada
Tel. +1-514-223-9153 ext.206
Europe
2A Rue Adolphe Diederich
5820 Fentange
Luxembourg
Tel. +352.20.88.01.30 ext.206

19. Ask