Re: [dita-pharma] RE: More thinking about Pharmaceutical Documentsand DI

Hi Joel and Jim,

DITA has significant capabilities for conditional processing. I will put some resources together and post them tomorrow.

Regards,

Michael

All,

I agree with Joel’s specific concepts outlined below as being essential in pharma documentation.

Having said that, I don’t believe the capability of having content which is optionally included, document specific or of a repeatable nature depends upon the DITA standard or specifically on the concept of a topic map.

These capabilities are at least equally dependent upon the toolset with which one generates each topic map.

As long as a topic map can be created for any single document, the question then becomes what does one have to do in order to create the correct topic map for the document in question.

I see this view as one that clearly must distinguish the topic map from the more static concept of a traditional template as we have used for authoring content in MS Word.

As I see it, there is still a need in DITA for libraries of commonly used topic map components (or sub-maps) which can be dynamically combined to generate the right instance of a topic map as needed.

In this way, there is consistency in the structure while allowing a dynamic assembly of the specific structure needed for any given document.

Having put forth this view that topic maps are dynamically assembled, I would also say in practice pharma documentation will “re-use” many topic maps (of course with updated topic binding).

A key assumption here, if we are thinking about clinical studies, is that while there are many different designs for clinical studies, good designs do tend to be re-used and while the specific content may vary for each study (i.e., there will be no two studies that are exactly alike) there will be a high degree of re-usable topic map components (i.e., sub-maps).

Thoughts?

-- Jim

From: Brennan, Michael [CNTUS] [mailto:MBrenna3@its.jnj.com]
Sent: Monday, November 08, 2010 1:36 PM
To: Joel Finkle; dita-pharma@lists.oasis-open.org
Cc: Laura.Zupko@gsk.com; Martin.Sjoholm@astrazeneca.com; David.H.Brown@astrazeneca.com; thomas.brunner@novartis.com; janet.stoltenborg@astrazeneca.com; peter_civitarese@merck.com; Monica.Mehta@genzyme.com; Brooke.Hinkson@genzyme.com; averbacj@ls-integration-partners.com
Subject: RE: More thinking about Pharmaceutical Documents and DITA: Maps versus Templates

Joel:

Good questions.

Adding to your questions – I am not sure that I would call inclusion/exclusion criteria as “repeating components” . It depends whether you view inclusion/exclusion criteria as a section vs a collection of criteria. Some criteria will be shared across protocol while others will be revised or new criteria created.

Other point that we need to consider is whether a given element (topic) will be referenced by another file. How critical is it to have “persistent meta-data” that will help define “authoritative sources” of information.

Michael

From: Joel Finkle [mailto:Joel.Finkle@imagesolutions.com]
Sent: Monday, November 08, 2010 12:42 PM
To: dita-pharma@lists.oasis-open.org
Cc: Brennan, Michael [CNTUS]; Laura.Zupko@gsk.com; Martin.Sjoholm@astrazeneca.com; David.H.Brown@astrazeneca.com; thomas.brunner@novartis.com; janet.stoltenborg@astrazeneca.com; peter_civitarese@merck.com; Monica.Mehta@genzyme.com; Brooke.Hinkson@genzyme.com; averbacj@ls-integration-partners.com
Subject: More thinking about Pharmaceutical Documents and DITA: Maps versus Templates

I've come across another topic that's worth thinking about in terms of the DITA standard and extensions needed for Pharmaceutical Regulatory documents: The DITA Map specification is pretty darn slim.

The DITA Map is how topics are collected into documents, and they are listed as sequential, tabular, etc.

This is sufficient to describe the output document that has been created from topics, but I don't think it's enough to be a template for a lot of regulatory documents.

Specifically, the DITA Map concept does not seem to include concepts such as:

· Optional components (e.g. a pediatric safety statement in a protocol)

· Selection from a choice (taking the protocol again, a standard, versus pediatric versus geriatric template, all based on a single set of topics)

· Repeating components (e.g. adding another objective, inclusion criteria, study event, etc.)

In my mind, a system that is capable of storing templates for creating regulatory documents, should be able to handle these concepts, and create (from templates) the needed topics as you make your choices and add to lists of items.

This doesn't seem to be part of the DITA standard. I don't have much experience with DITA tools, so it's possible that this has already been implemented. I need to look at more of the commercial tools and the Open Toolkit.

Joel

----

Joel Finkle
Director, Regulatory Informatics

		Image Solutions, Inc.
		100 South Jefferson Road
		Whippany, NJ 07981
		T: 847.989.6028
		joel.finkle@imagesolutions.com

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