OASIS Mailing List ArchivesView the OASIS mailing list archive below
or browse/search using MarkMail.

 


Help: OASIS Mailing Lists Help | MarkMail Help

dita-pharma message

[Date Prev] | [Thread Prev] | [Thread Next] | [Date Next] -- [Date Index] | [Thread Index] | [List Home]


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

----

Joel Finkle

Director, Regulatory Informatics

http://www.imagesolutions.com/Portals/0/images/emailsig/isilogo.gif

 

Image Solutions, Inc.

100 South Jefferson Road

Whippany, NJ 07981

T: 847.989.6028

joel.finkle@imagesolutions.com

 


The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from all computers.


[Date Prev] | [Thread Prev] | [Thread Next] | [Date Next] -- [Date Index] | [Thread Index] | [List Home]