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Subject: Thinking about Pharma/Regulatory documents: Synopsis
After looking at the Business Documents stuff for a bit, I
started looking over a couple of Clinical Protocols our customers have passed
my way when a document needs repair (I'm not a medical/regulatory writer, just
a toolsmith). The first thing that started worrying me is the Synopsis:
it's a highly structured, abbreviated version of much of the entire document. A
lot of it, but not all of it, is metadata from other components. So later in the day, I had a thought: HYPOTHESIS: A study report
Synopsis is not a topic or component, rather it is a different view of the (protocol
or report) components. In DITA terms, that would probably mean a different topic
map onto most of the same components that make up the protocol or report. To make that work, though, there would
need to be appropriate metadata on those components, and possibly abbreviated
text of the particular topic, (objectives, conclusions etc. etc.) that would be
used for the Synopsis and probably not appear in the body. Example with crude XML: <objective><title>Study
Objectives</objective> <objectivebody > <shortdesc> <list> <item>to determine the safety
and efficacy of three doses of nosuchacin vs. wonderdrug in pediatric subjects
with acute hiccups</item> <item>to determine time to
loss of disease control and ability to regain response upon retreatment</item> <item>to examine the
pharmacokinetics and immunogenicity of nosuchacin following oral administration
in this subject population</item> </list> </shortdesc > <details>The objectives of
this study are to determine the safety and efficacy of three doses of nosuchacin
versus wonderdrug in pediatric subjects with acute hiccups, to determine the
time to loss of disease control and the ability to regain response upon
retreatment, and to examine the pharmacokinetics and immunogenicity of nosuchacin
following administration in this subject population.</details> </objectivebody> </objective> In this case, the text is nearly identical, they're shown in
two forms because the Objectives section of the protocol used one long
sentence, versus the synopsis which has a bullet list. A style sheet might be able to construct
the details version from the list version, if it knew that the study objectives
needed that. Tricky but not
impossible. (Note: More than likely, each objective would be a separate topic…
but how do you construct that one narrative sentence cleanly?) <task><title>Subject
Selection</title> <shortdesc>Male or female pediatric
subjects including children (age 4 to 11 years) and adolescents (age 12 through
17 years)</shortdesc> <taskbody>Pediatric subjects
who are eligible for enrollment will be male or female subjects including
children (age 4 to 11 years) and adolescents (age 12 through 17 years) who meet
all of the inclusion criteria and none of the exclusion criteria specified in
Section 5.2.1
and Section 5.2.2
of this protocol.</taskbody> <related-links><link>Section
5.2.1</link><link>Section 5.2.2</link> // Yes, I know that's not how references
are done, I'm lazy </task> Here, the text is still somewhat similar, but I'm not sure
that a style sheet could construct the "Pediatric subjects who are
eligible for enrollment will be" (possibly if "Pediatric" were not
needed) and "who meet all of the inclusion criteria and none of the
exclusion criteria". The more
I look at this, not having separate versions might cause writers to become
anxious about the lack of control over the synopsis text. Does this make sense? Joel ----
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