initiative for an etmf exchange mechanism from the tmf reference model
Post on 22-Jul-2015
629 Views
Preview:
TRANSCRIPT
Paul Fenton
CEO Montrium Inc.
Initiative for an eTMF Exchange Mechanism from the TMF Reference Model
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.
© 2015 DIA, Inc. All rights reserved.
What are we trying to solve
© 2015 DIA, Inc. All rights reserved.
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
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 eCTDand CDISC as inspiration
Different approach to OASIS which would focus on content transfer rather than real-time interoperability
Work in Progress….
© 2015 DIA, Inc. All rights reserved.
How it works
© 2015 DIA, Inc. All rights reserved.
Study #
Process Zone
Section
Section
Section
Artifact
Artifact
Content Export XML Inventory
Exchange XML Files
© 2015 DIA, Inc. All rights reserved.
content.xml metadata.xml
+
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.
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
© 2015 DIA, Inc. All rights reserved.
Example File – Content.xml
© 2015 DIA, Inc. All rights reserved.
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
© 2015 DIA, Inc. All rights reserved.
Example File – Metadata.xml
© 2015 DIA, Inc. All rights reserved.
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.
Secret of Success
Try and keep the mechanism as flexible and simple as possible
Ensure that all stakeholdersare involved (sponsors, CROs, vendors + others)
Ensure direct alignment with the TMF RM – natural evolution
Make it easy for vendors to implement and maintain
© 2015 DIA, Inc. All rights reserved.
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
© 2015 DIA, Inc. All rights reserved.
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.
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.
Want to get involved?
Interested in participating?
© 2015 DIA, Inc. All rights reserved.
Contact Details
DIA
Paul Fenton
pfenton@montrium.com
www.montrium.com
Twitter: @paulkfenton
North America507 Place d’Armes
Suite 1050Montreal (QC) H2Y 2W8
CanadaTel. +1-514-223-9153 ext.206
Europe2A Rue Adolphe Diederich
5820 FentangeLuxembourg
Tel. +352.20.88.01.30 ext.206
Ask
top related