RE: [etmf-comment] eTMF Vocabulary & NCI

Thanks Jennifer. This supports the reply I received earlier from OASIS (Paul Knight) and helps to clarify for the end-user community not so familiar with the TC where the terms in the draft vocabulary originate from.

Kind regards,

Eldin.

Eldin Rammell

Managing Director, RAMMELL Consulting Ltd

Office: +44 (0)844 8844926 Direct dial: +44 (0)1905 617 716 Mobile: +44 (0)7940 859721

IM Skype: eldin.rammell

Have you checked out our training courses at http://rmtrain.eventhq.co.uk ?

From: etmf-comment@lists.oasis-open.org [mailto:etmf-comment@lists.oasis-open.org] On Behalf Of Jennifer Alpert Palchak
Sent: 19 June 2014 14:06
To: 'Eldin Rammell'; etmf-comment@lists.oasis-open.org
Subject: RE: [etmf-comment] eTMF Vocabulary & NCI

Hi Eldin,

In response to your questions about the eTMF vocabulary as it relates to NCI and CareLex, you have some valid questions, but the questions infer several inaccurate assumptions. As is typical with many Technical Committees, members of the TC often contribute work to the TC as a starting point. Such is the case with the OASIS eTMF TC; CareLex contributed several bodies of work as a starting point for the eTMF TC to consider and work from if the TC found the contributions useful.

CareLex has spent hundreds of hours working with NCI over more than a year to develop a controlled vocabulary at NCI. This work began prior to the OASIS eTMF Standard TC’s formation and the body of work was first published at the Stanford National Center for Biomedical Ontology (Bioportal) for public review in 2012. View CareLex’s work here: http://bioportal.bioontology.org/ontologies/CARELEX?p=classes

Upon formation of the OASIS eTMF Standard TC, CareLex submitted—and contributed per the Non-Assertion Mode TC Requirements of the eTMF TC Charter—a set of Category Terms, Annotation Properties, and Data Properties (collectively called Terms in this email) as a body of work for the OASIS eTMF TC to consider as a starting point, just as we contributed the technical specification to the TC for use as a starting point.

CareLex has repeatedly informed the TC members that these terms were pulled together from a variety of sources and has noted such sources in our TC slides. Each source is also indicated in our work with the NCI, which publishes the terms for use by the global community. Information has also been provided to the TC about CareLex’s work with NCI and NCI’s assessment of terms submitted by organizations.

While CareLex submitted the set of terms as a possible starting point for the TC, it is completely up to the collective OASIS eTMF Standard TC to determine what the group will and will not use to achieve interoperability of the eTMF. The TC’s Metadata Workgroup spent time during three lengthy meetings reviewing and questioning the terms initially submitted and now seeks public comment regarding the list of terms as well as the technical specification. Of course, the multiple rounds of Public Review will further inform the TC about the approach with the broadest appeal and use. As part of the public review process, we anticipate additional terms and term modifications will be submitted for the TC to assess and adopt or reject with the ultimate goal being broad adoption of the standard.

CareLex’s work is open to public use and our aim is that the body of work resulting from OASIS eTMF Standard TC is widely applicable, free and open for industry use. The mission of CareLex is to improve information interoperability in health sciences to accelerate delivery of new therapies to patients at a lower cost and it is toward this goal that we have focused on interoperability of the electronic trial master file.

As a reminder, the OASIS eTMF TC is open to any and all who wish to join OASIS and the work of eTMF Standard TC in order to advance a global standard for interoperability of the electronic trial master file.

Kind regards,

Jennifer Alpert Palchak, CEO

CareLex

From: etmf-comment@lists.oasis-open.org [mailto:etmf-comment@lists.oasis-open.org] On Behalf Of Eldin Rammell
Sent: Tuesday, June 17, 2014 11:06 PM
To: etmf-comment@lists.oasis-open.org
Subject: [etmf-comment] eTMF Vocabulary & NCI

Would OASIS please explain:

(1) why DRAFT TMF vocabulary has been submitted to NCI for adoption into the NCI Thesaurus BEFORE the vocabulary has completed its formal review and approval process. The acceptance and publishing of these terms by NCI gives the impression that these are final terms, making the 45-day public review process redundant;

(2) why CareLex is acknowledged by NCI as the source of these terms rather than OASIS;

(3) why CareLex is identified on the OASIS vocabulary spreadsheet rather than OASIS.

It appears that this is a CareLex taxonomy that has been submitted to NCI and released for public review rather than a draft OASIS vocabulary.

Regards,
Eldin Rammell,
Managing Director, Rammell Consulting Ltd.

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