Optimizing the Use of Data Standards Define-XML 2.0 Stylesheet - - PowerPoint PPT Presentation

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Optimizing the Use of Data Standards Define-XML 2.0 Stylesheet - - PowerPoint PPT Presentation

Nov 09, 2022 195 likes •273 views

Optimizing the Use of Data Standards Define-XML 2.0 Stylesheet Recommendations PhUSE Webinar 16 November 2016 Introduction Define-XML v2 is an XML based CDISC metadata standard used to describe any tabular dataset structure. The primary use

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Define-XML 2.0 Stylesheet Recommendations PhUSE Webinar 16 November 2016

Optimizing the Use of Data Standards

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Introduction

  • Define-XML v2 is an XML based CDISC metadata standard used to describe

any tabular dataset structure. The primary use case for Define-XML has been to describe CDISC SDTM, SEND and ADaM datasets for the purpose of submissions to the Regulatory AuthoriGes.

  • Regulatory reviewers can view the contents of a Define-XML document in a

browser through an HTML rendiGon created by a so-called XSL stylesheet.

  • CDISC publishes default XSL stylesheets as part of the Define-XML v2

publicaGon packages.

  • Currently, the XSL stylesheet is not part of the Define-XML standard.
  • The CDISC XSL Define-XML stylesheets are published under a MIT license.
  • Sponsors are free to use the stylesheet, adapt it, or create their own.
  • This leads to variaGons in what reviewers see when reviewing Define-XML

documents, and can even lead to issues because of sponsor customizaGons.

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Introduction

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Define-XML 2.0 Stylesheet Recommendations - Phase 1


  • Development of a Define-XML v2 stylesheet for regulatory

submissions, by reviewing and updaGng the exisGng CDISC stylesheet, and implemenGng most common requests.

  • The main goals are compaGbility with regulatory requirements,

stability, and completeness.

  • Join the (small) team:

– Help reviewing – Share stylesheet feedback you received – Other tasks, ...

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Define-XML 2.0 Stylesheet Recommendations - Phase 2


  • Phase 2 is assumed to be more experimental stage. In this stage we are

planning to use modern browser capabiliGes and external libraries to show Define-XML informaGon in a more interacGve way.

  • Demonstrate other uses of a stylesheet, without bothering too much about

current technical restricGons.

– Not limited to legacy browsers – HTML 5 / CSS 3 – Advanced funcGonality with JavaScript – Possible usage of a web library or framework (jQuery, Bootstrap, ...)

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Points of Contact


  • Dmitry Kolosov (Co-Lead), PAREXEL

dmitry.kolosov@parexel.com

  • Lex Jansen (CDISC Define-XML Team Liaison), SAS InsHtute Inc.

lex.Jansen@sas.com