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RE: [COI] Following up on your comment re "underlying model" in your reviewing the functional requirements spreadsheet

From: Kashyap, Vipul <VKASHYAP1@PARTNERS.ORG>
Date: Mon, 29 Oct 2007 13:28:13 -0400
Message-ID: <DBA3C02EAD0DC14BBB667C345EE2D124010F04F8@PHSXMB20.partners.org>
To: "Forsberg, Kerstin L" <Kerstin.L.Forsberg@astrazeneca.com>, <alanruttenberg@gmail.com>
Cc: <public-semweb-lifesci@w3.org>

> my comment was about the need for a "underlying model". While the issue I
> raised is about our current focus on the mappings between specific terms
> in different terminologies. Instead I would like us to move beyond the
> mappings and focus more on how to specify different types/classes/kinds of
> clinical observations.

[VK] This is exactly, which I have divided the functional requirements
spreadsheet into three parts now:
- Information Models
- Terminologies
- Data Types and Units

> SDTM's information
> model assumes a flat file structure of variables for information
> interchange/submissions to FDA (see slide 7 and 8).

[VK] Yes, that might be an issue when it comes to map "flat constructs" in SDTM
to "nested constructs" in DCM and other Healthcare models. 

>       So far, CDISC do not provide a common model to specify the different
> types/classes/kinds of observation descriptions: what observations of
> "real-world phenomenon" they describe using different terminologies, the
> contextual information required to interpret the observation results,
> alternative classifications and formats for the observation results etc..
> Instead sets of terms / codes / "submission values" are published as
> CDISC's own controlled terminologies using terms such as "ALT", "CRP" and
> "DIABP" 2] defined in NCI Thesaurus (see slide 5).

[VK] This is exactly what we will figure out how to handle when we do the
mapping exercise.

>       CDISC SDTM include a trial design variable for inclusion/exclusion
> criterion rules "in computer-executable form" (see slide 3). This is very
> good, but as long as we lack a common way to specify, and identify, the
> different types/classes/kinds of clinical observations, I think it will be
> hard to express such rules.

[VK] Absolutely agree with the above! The key issue is getting the underlying
information models right. Specifying rules/axioms to express the protocols will
follow easily. It is interesting to note that most of the BRMS engines focus on
building a robust Business Object Model which is the vocabulary for specifying
these business rules.

Nice to see the meeting of the minds!


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Received on Monday, 29 October 2007 17:28:38 UTC

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