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 |
||
