© CDISC 2014 Asthma TAUG Metadata Bundle Review – Experimental Content PhUSE Computational Science Symposium March th, 2015 Sam Hume 1

© CDISC 2014 Asthma TAUG Metadata Bundle Review Seeking new ways to deliver content developed by the CFAST TA standards development projects. As a result of this review we hope to:  Send new content requirements to the standards development teams.  Create Jira issues for the SHARE team to communicate new requirements for formatting the package.  The purpose of the review is not to QC the content (though we're happy to create Jira issues related to content issues) 2

© CDISC 2014 TAUG Metadata Bundle The intent is to provide a bundle that includes all the metadata needed to implement a TA within a study. The objective is to make the TAUG content easier to apply and more useful. The content in the Asthma TAUG Metadata bundle  Is "Experimental"  Some content is programmatically generated from SHARE  Some content was manually created because content is not available as part of the standard  None of the content has been QC'd  Content is Excel based only now, but other formats are planned 3

© CDISC 2014 Review: Content Perspective Given the files that are present in the metadata bundle, how well does this content meet your needs? Are additional sources of content needed? Given the content in the files, are there additional metadata elements / attributes needed? Given the files that are present, is the content organized in a manner that suits your needs? 4

© CDISC 2014 Review: Technical Perspective Is the content organized in a manner that suits your needs? What would improve the machine-readability of the content? Is additional metadata needed to use this content in your applications? What additional formats would be useful?  Currently planning to include XML and RDF 5

© CDISC 2014 Additional food for thought… Versioning  Planning to publish v1.0 TAUG domains and use these within existing standards such as SDTM IG 3.2  Submissions will be based on a baseline standard version + overrides for specific new domains Value Level Metadata (VLM)  Planning to add VLM as part of the standard  What does an ideal VLM library look like?  How will you apply this content? 6

© CDISC 2014 Additional food for thought… Codelist subsetting  Standard re-usable subset (e.g. units in VLM)  Codelist versioning? Datatypes  Define-XML and RDF datatypes based on XML Schema Examples  Would publishing examples as metadata be useful (on a scale of 1- 5)? Rules  Would publishing validation rules be useful (on a scale of 1-5)? 7

© CDISC 2014 TAUG Metadata Bundle Content Package Contents for Asthma-TAUG-v1-0-Draft.zip:  sdtm-ta-asthma-taug.xls  sdtm-ta-asthma-routine.xls  sdtm-ta-asthma-medical-device.xls  cdash-ta-asthma.xls  ct-sdtm-ta-asthma.xls  ct-cdash-ta-asthma.xls  FATEST Listing.xslx  HbA1c and Glucose SHARE Metadata.xslx  SuppQual Listing.xls  taug_asthma_v1.0_single.pdf  taug_asthma-readme.pdf 8

© CDISC 2014 Your feedback… Enter issues into Jira located on the CDISC wiki  SHARE project Version R3  Component eSHARE  Fix version R3  Epic eSHARE content (173) Or, capture as text and to  Subject: PhUSE CSS TAUG Review 9

© CDISC 2014 Wrap Up… Thank you for you review efforts A summary of the findings will be posted on the CDISC wiki, and I will make it available for posting to the PhUSE wiki All actionable items will be loaded into Jira (if they're not already there) Questions? 10

© CDISC Thanks!

© CDISC 2014 Strength through collaboration. 12