Dataset CDISC StudyDataSet-XML Leaving the Stone Age of data - - PowerPoint PPT Presentation

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Dataset CDISC StudyDataSet-XML Leaving the Stone Age of data - - PowerPoint PPT Presentation

Jan 28, 2023 377 likes •532 views

Dataset CDISC StudyDataSet-XML Leaving the Stone Age of data transmission PhUSE SDE Copenhagen, 11th June 2014 Sven Greiner Statistical Programming, Accovion GmbH 1 Sven Greiner CDISC Dataset-XML, 11 th June 2014, PhUSE SDE Copenhagen 2014

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 1

CDISC StudyDataSet-XML

Leaving the Stone Age of data transmission

PhUSE SDE Copenhagen, 11th June 2014 Sven Greiner Statistical Programming, Accovion GmbH

Dataset

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 2

Contents

I. Dataset-XML – what and why?

  • II. Introduction to XML & ODM
  • III. Implementing Dataset-XML
  • IV. Dataset-XML Tools
  • V. Next Steps
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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 3

  • I. Dataset-XML – what and why?

What is Dataset-XML?

  • Defines format for transporting datasets in XML
  • Based on the Operational Data Model (ODM)
  • Supports ADaM, SDTM, SEND and other data
  • Transport of datasets in FDA submissions
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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 4

  • I. Dataset-XML – what and why?

Why Dataset-XML?

  • FDA recommends SAS Transport v5 in 1999
  • Limitations:
  • 8 char variable names, 200 char variable length, 40 char

label length

  • Huge dataset sizes
  • …
  • FDA in November 2012: Dataset-XML an

alternative for consideration

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 5

  • II. Introduction to XML & ODM

The Extensible Markup Language (XML)

  • Open standard produced by the W3C
  • XML is a textual data format
  • Data has to conform to an XML schema

<svg xmlns="http://www.w3.org/2000/svg" version="1.1“ width="500" height="400"> <rect x="0" y="210" width="300" height="240" fill="blue" /> <ellipse cx="280" cy="230" rx="190" ry="120" fill="yellow"/> <path d="M150 200 L50 400 L250 400 Z" stroke="black" fill="lime" /> <text x=“180" y="240" font-family="Arial" font-size="30"> Hi Copenhagen </text> </svg>

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 6

  • II. Introduction to XML & ODM

The Operational Data Model (ODM)

  • Format for the interchange and archival of clinicial

study data using XML

  • Includes:
  • Clinical data, associated metadata, administrative data,

reference data and audit information

  • Covers all aspects of clinical reasearch data
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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 7

  • III. Implementing Dataset-XML

Features of Dataset-XML

  • Dataset-XML is an extension of ODM
  • One XML-file per dataset
  • Metadata stored outside the dataset (Define.xml)

ae.xml dm.xml cm.xml Define.xml

Data Metadata

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 8

  • III. Implementing Dataset-XML

ItemData ItemGroupData ClinicalData or ReferenceData ODM XML Header

Dataset-XML elements

  • Contains value for one variable

within an item group (record)

  • Contains data for an item group

(record)

  • CD: subject data for one dataset
  • RD: non-subject data for one dataset
  • Root element including document-

wide attributes

  • Indicates beginning of an XML file
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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 9

  • III. Implementing Dataset-XML

CM example

The example file is part of the „CDISC Dataset-XML Specification Version 1.0“ package.

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 10

  • IV. Dataset-XML Tools

Overview

Tool Description EZ Convert ü Converts Dataset-XML files into SAS datasets SAS Clinical Standards Toolkit ü Dataset-XML support will be part of the next release of CST OpenCDISC v1.5 ü OpenCDISC v1.5 works with Dataset-XML files and Define-XML v2.0 XPT2DatasetXML ü Transforms XPT datasets into Dataset-XML datasets Smart Dataset-XML Viewer ü Shows Dataset-XML files as tabular datasets

Source: http://wiki.cdisc.org/display/PUB/CDISC+Dataset-XML+Resources

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 11

  • IV. Dataset-XML Tools

Smart Dataset-XML Viewer (1)

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 12

  • IV. Dataset-XML Tools

Smart Dataset-XML Viewer (2)

<ItemGroupData ItemGroupOID="IG.CM" data:ItemGroupDataSeq="1"> <ItemData ItemOID="IT.STUDYID" Value="CDISC01"/> <ItemData ItemOID="IT.CM.DOMAIN" Value="CM"/> <ItemData ItemOID="IT.USUBJID" Value="CDISC01.100008"/> <ItemData ItemOID="IT.CM.CMSEQ" Value="1"/> <ItemData ItemOID="IT.CM.CMTRT" Value="PROCARDIA XL"/> <ItemData ItemOID="IT.CM.CMDECOD" Value="NIFEDIPINE"/> <ItemData ItemOID="IT.CM.CMCAT" Value="CONCOMITANT MEDICATIONS"/> <ItemData ItemOID="IT.CM.CMINDC" Value="HYPERTENSION"/> <ItemData ItemOID="IT.CM.CMCLAS" Value="CALCIUM CHANNEL BLOCKERS"/> <ItemData ItemOID="IT.CM.CMCLASCD" Value="C08"/> <ItemData ItemOID="IT.CM.CMDOSTXT" Value="60"/> <ItemData ItemOID="IT.CM.CMDOSU" Value="mg"/> … </ItemGroupData>

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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 13

  • V. Next Steps

What is next for Dataset-XML?

  • FDA
  • Complete the pilot project (January 2015?)
  • Create infrastructure
  • Allow Dataset-XML for submissions
  • Industry
  • Wait for FDA decision
  • Staff training
  • Adjust processes
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Sven Greiner – CDISC Dataset-XML, 11th June 2014, PhUSE SDE Copenhagen 2014 14

Questions?

Beate Hientzsch

Director, Statiscal Programming

Accovion GmbH Helfmann-Park 10 D-65760 Eschborn, Germany

  • Tel. +49 6196 7709-288

sven.greiner@accovion.com www.accovion.com Senior Statistical Programmer

Sven Greiner