Initiative for an eTMF Exchange Mechanism from the TMF Reference Model

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.

What are we trying to solve


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….


How it works


Study #

Process Zone

Section

Section

Section

Artifact

Artifact

Content Export XML Inventory

Exchange XML Files


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


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


Example File – Content.xml


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


Example File – Metadata.xml


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


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


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


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….


Want to get involved?

Interested in participating?


Contact Details

DIA

Paul Fenton

[email protected]

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

mailto:[email protected]

http://www.montrium.com

Initiative for an eTMF Exchange Mechanism from the TMF Reference Model

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