AE Narrative Template

Use this option to specify the template to use for your narrative.

The narrative document generation uses the Velocity Template Engine, an open-source project that is hosted by the Apache Software Foundation. The Velocity engine enables a clean separation between the presentation and organization of content and the data being presented. As such, an array of templates can be created, each customizing the narrative in a variety of layouts and/or styles. The templates are read by JMP Clinical at run time and available for selection when creating the final document. The result of this design enables very customizable output that can be altered and/or extended as appropriate for different types of studies or specific regulatory requests.

The template language itself has a simple syntax that not only supports substituting values for variables, but also supports conditional logic, looping constructs, and string manipulation and arithmetic functions. Refer to the Apache Velocity Project User Guide for the full details of the template syntax.

Specifically for JMP Clinical, the narrative generation report starts by first generating a table of metadata values and a table of the adverse event data. The selected template is then merged with these data sets to produce the narrative document. The template content is a mixture of the static sentence information and snippets of substitution variables and logic for controlling which sentences are displayed, the order in which they are displayed, and which specific words/phrases/tables/etc. should make up the narrative. This enables templates to be created that support any language and still conform to the appropriate grammar rules of that language.

Three VM files define a template: a header file, a footer file, and a content file. The content file has nothing appended to the name and this name is surfaced in the drop-down menu.. The _Header.vm and _Footer.vm suffixes must be appended to names of the header and footer files, respectively. For example, the default template files, included with JMP Clinical, are Default.vm, Default_Header.vm, and Default_Footer.vm.

Template files are located at **/user/clinical/narrativetemplates . The default location for this path is %APPDATA%\SAS\JMPClinical\14\JMPC\NarrativeTemplates. Adding additional, VM template files in this path will make those templates available for the users to select when generating the AE Narrative report.

Four templates are included with JMP Clinical. These templates can be modified to generate custom templates.

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Default - One event per page. All subject-level information is repeated for every event, on every page.

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DefaultByEvent - This template shows the subject's event records starting each event on a new page. The subject's demography and other header information is included for every event record. The collection of events may span multiple pages and are grouped by subject. This template also provides an example of watermarks.

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DefaultBySubject - All events are grouped by subject. The collection of events may span multiple pages. Different subjects will always start on a new page. The subject-level information is only listed at the beginning of the list of events. This template also provides an example of watermarks.

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DefaultBySubjectChinese - Same as DefaultBySubject, content is translated into Chinese. Note: edits to this template require an editor that can handle content with a UTF-8 encoding.

Note: If a template does any filtering of subjects, the number of subjects in the index document may differ from the number in any given file. The index file is based on the total number of subjects in the study, but the template may prevent some/all subjects from being surfaced in any given document.

To Specify the Narrative Template:

Select the desired template from the drop-down menu.

Note: If JMP Clinical detects a template that is older than the current configuration, you will be prompted (with the following window) to update the update the narratives using the Manage Configurations process