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Subject: RE: [etmf] Groups - eTMF TC Jan 20 2014 meeting tech discussion uploaded


A couple of thoughts about terminology:

 

1.       It may be helpful to maintain continuity to the TMF Reference Model terminology along with the terminology being proposed for OASIS. 

a.       Primary Category = Zone

b.      Sub Category = Section

c.       Content Types = Artifact

2.       The term  Content Type as shown in the diagram below may cause some confusion.  I view a content type as a group of related Artifacts or Documents that have the same metadata properties.  For example, all Site level artifacts would be in a Content Type that need to have the country name and site number  metadata properties assigned.  One of the metadata properties of the artifact can be the template or form to use to create the document, for example the Form 1572.  However, the Form 1572 template metadata property would not apply to all the artifacts in the Site level Content Type.  I perceive that more clinical people will relate to a term of “Document Name” rather than “Content Type”.

 

“A content type is a collection of settings and metadata that describe how an item created with that type is identified, and how it will behave within your system. A content type could apply to a document, a folder, or a variety other objects. - See more at: http://www.aiim.org/community/wiki/view/Content-Types-and-Metadata#sthash.sWl14tWR.dpuf

 

Screen shot of slide 6 from the deck for Jan 20 meeting

 

3.       I see that the OASIS eTMF Model is fairly consistent to the DIA TMF Reference Model, but not exactly.  Is there any documentation about the differences between the two models and rationale, or is this something the group should develop?  If I was a vendor for eTMF systems that has implemented the DIA Reference Model, then I would want to know the delta between the two models.

 

Michael Agard | Principal Consultant | Paragon Solutions | www.consultparagon.com

email:  magard@consultparagon.com  phone:  610.832.8110 | fax:  610.832.8115 | cell:  484.889.7136

 

 

** Confidential **

 

From: etmf@lists.oasis-open.org [mailto:etmf@lists.oasis-open.org] On Behalf Of Zack Schmidt
Sent: Tuesday, January 14, 2014 7:03 PM
To: etmf@lists.oasis-open.org
Subject: [etmf] Groups - eTMF TC Jan 20 2014 meeting tech discussion uploaded

 

Submitter's message
Meeting preparation materials for Jan 20 '14 meeting.

- Please review this if possible prior to meeting.

Thanks,
Zack Schmidt
-- Mr. Zack Schmidt

Document Name: eTMF TC Jan 20 2014 meeting tech discussion


Description
Meeting preparation materials for Jan 20 '14 meeting.

- Please review this if possible prior to meeting.

Thanks,
Zack Schmidt
Download Latest Revision
Public Download Link


Submitter: Mr. Zack Schmidt
Group: OASIS Electronic Trial Master File (eTMF) Standard TC
Folder: Documents
Date submitted: 2014-01-14 16:02:34

 

PNG image



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