One area where the DITA Pharma group has a leg up is that
there is already a taxonomy of Regulatory -- and now Drug/Substance Master File
-- documents, in the DIA EDM Reference Model.
However, a thought just occurred to me:
It's obvious that the EDM Reference Model does not have the
entire taxonomy for component-based authoring, since it deals with documents
that are -- even in their most granular form -- collections of what should be
components.
What I hadn't thought about until this morning, though, is
that the Reference Model taxonomy creates a strict tree structure* based on the
Common Technical Document. However, with a component-based system, there will
be components that are re-used or re-purposed across several branches of the
tree (or at least we hope so, or this whole process is of limited value,
right?).
This is not a fatal flaw, but it's something we'll need to
consider when decomposing the larger document types, and if there is any
collaboration with the EDM Reference Model team. We need to make sure we have a
way of mapping a component into several places in the CTD hierarchy, and not
pin it to just one place. This also
might lead to changes in the Reference Model.
Joel
*
Somewhat -- there's a fuzzy region for things like study reports, where there
are a fist-full of places a study report can go
----
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Joel Finkle |
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Director, Regulatory
Informatics |
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Image Solutions, Inc. |
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100 South Jefferson
Road |
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Whippany, NJ 07981 |
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T: 847.989.6028 |
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