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

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 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.

Introduction

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, ...

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, ...)

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