Introduction to Define-XML

Define-XML
CDISC Educational Materials
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Sharing, copying, recording or reselling any
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slides, quizzes, and all other materials provided as part of
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© CDISC 2012
Define-XML

© CDISC 2012
 Topics

Introduction
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

4
Class Materials
• Define-XML Course Folder:
 Define-XML Training.pdf (slides)
 Define-XML Exercises Folder
 Define-XML Specification (pdf file)

• Reference web sites

 http://www.CDISC.org
 http://www.cancer.gov/cancertopics/terminologyresource
s/CDISC (CDISC terminology/codelists)

© CDISC 2012
Course Objectives
• Learn how Define-XML fits with other CDISC models.
• Learn how to represent SDTM and AdaM metadata for
datasets, variables, controlled terminology using
Define-XML.
• Become familiar with Define-XML 2.0 capabilities for
representing value or parameter level metadata.
• Learn how to provide traceability for SDTM and ADaM
data
• Learn about Analysis Results Metadata in XML
• Learn how Dataset-XML can be used in place of SAS-
XPT datasets
• Learn about strategies for resolving common Define-
XML implementation issues.

© CDISC 2012
Notes

• Our goal is to provide comprehensive training for

individuals who are implementing Define-XML.
The process of building Define-XML involves
many disciplines. Individuals who need to work
with Define-XML come from diverse backgrounds
– with varying levels of technical experience.
• Please provide feedback.

© CDISC 2012
 About the Trainer
• Primary CDISC affliation
• Current position/organization
• How your work relates to CDISC XML Technology
Standards
• Other qualification (years experience in related field)

© CDISC 2012
Participant Introductions
• Organization

• Job function/role

• Experience with Define-XML

• XML background

• Other CDISC standards (SDTM, SEND, ADaM)

9
© CDISC 2012
 Topics

Introduction
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

10
 What is Define.XML?
• CDISC XML Technology standard.
• Provides machine readable metadata for SEND,
SDTM and ADaM datasets.
• Provides a table of contents for people who need to
use CDISC datasets.
• Formatting standard based on the CDISC ODM
• Required by US FDA for all CDISC submissions.

11
 Protocol CDASH SDTM ADaM

Study Design Lab SEND

Define-XML
SDM-XML
SDM-XML ODM
ODM Define-XML
Dataset-XML

Glossary
Therapeutic Areas
BRIDG

SHARE Questionnaires

Controlled Terminology Healthcare Link

© CDISC 2012
 SEND SDTM ADaM SEND SDTM ADaM
Metadata Metadata Metadata Data Data Data

Define- Dataset-
XML XML

ODM
13
© CDISC 2012
 Machine Readable Metadata
• What makes Define-XML ‘machine readable’?
 XML can be easily read by a wide variety of application programs
 Standard mapping of CDISC submission metadata into a
standard XML format enables content sharing
• How does machine readable metadata help data review?
 Enables automated loading and validation of submissions
metadata by any application.
• Eliminates the need to retype dataset and variable names
 Enables consistency checking between metadata and data
 Encourages development of sophisticated submissions data
review tools
 Enables reuse of submission data for research purposes

© CDISC 2012
 Purpose of Define-XML
• US Food and Drug Administration (FDA) requires clinical
data for all clinical trials used as part the regulatory
approval process for new drugs and biologics.
• Reviewers need metadata that describes the content of
each submission.
• For SDTM submissions • For ADaM submissions
 Datasets included • Dataset definitions
• Variable definitions
 Dataset variables
• Derivations
 Controlled Terminology • Value level metadata
 Value level metadata • Controlled terminology
 Traceability to the CRF • Traceability to SDTM

15
© CDISC 2012
Other Applications of Define-XML
• Sponsors use Define-XML to specify requirements
for datasets to be delivered by CROs or other 3rd
party data providers

• CROs provide Define-XML with dataset deliveries

• For submission of legacy analysis datasets

• Provides Metadata for CDISC Dataset-XML

datasets (proposed replacement for SAS XPT)

© CDISC 2012
Define-XML features
• Platform independent
• Vendor neutral
• Open source
• Machine readable
• Easily transformed
using XSL and other
tools
 Regulatory Requirements
Japan:
(PMDA Technical
Conformance Guide
(English version))

© CDISC 2012
Regulatory
Requirements
PMDA
DataCatalog_20150731ENG.xls
Regulatory
Requirements
FDA Guidance
 Improvements in Define-XML 2.0
• Machine readable value level metadata
• Enhanced support for CDISC controlled terminology
• Improved support for documenting links to annotated
CRFs, ADaM Traceability metadata
• Better support for comments
• New elements, attributes, and data types
• Reorganized specification document
• More extensive examples
• Reduced platform dependencies in XSL style sheet
• Self documenting schema
• No longer need to create Define.pdf

© CDISC 2012
Status of Define-XML 2.0
• Final version posted February 2013
• Can be downloaded from the CDISC website
(http://www.cdisc.org/define-xml)
• Not backward compatible w Define-XML 1.0
• Validation requirements and Implementation
Guide development in progress

BREAKING NEWS (03/17/2016)

2016-DefineFedRegNotice.pdf

© CDISC 2012
 Define-XML 2.0 - TOC
Download from the CDISC website http://www.cdisc.org/define-xml)

• Specification
• XML Schema
• Examples
 ADaM
 SDTM
 Includes XSL stylesheet

© CDISC 2012
 Topics

Introduction to Define-XML
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

24
Introduction to XML
• XML
 Stands for Extensible Markup Language.
 Text base system for data interchange
developed to support the WWW.
• Developed and supported by W3.org
• Encompasses XML Schemas, XSL Transforms, and
XPath
 Allows for data sharing between applications
• Across platforms
• Developed by different vendors
 Allows data to be read and interpreted by
people and machines.

25
© CDISC 2012
Example

26
© CDISC 2012
<PlayList name=“MyPlaylist”
CreationDate=“2013-09-19”> Root Element
<Song PlayTime=”227">
<Title>Shattered</Title>
<Artist>Rolling Stones</Artist> Attributes
<Album Genre=“Rock”>
<Title>Some Girls (Deluxe Edition)</Title>
</Album>
</Song>
Elements
<Song PlayTime=”231">
<Title>Eet</Title>
<Artist>Regina Spektor</Artist>
<Album Genre=“Alternative”>
<Title>Far</Title>
</Album>
</Song>
…
</PlayList>

27
© CDISC 2012
XML Schemas
• Definition:
 XML documents that describe structure and content for
a specific type of XML document
• Purpose:
 Standardize contents of XML documents for a specific
use case.
• XML namespace declarations
• Define allowable elements and attributes
• Define allowable datatypes for element and
attributes
• Define relationships between elements and attributes
• Define enumerations
 Support validation of XML documents

28
© CDISC 2012
Playlist Schema
Playlist Attributes name

CreationDate

Song Attributes Playtme

Title

Artist

Album Attributes Genre

Title

© CDISC 2012
 CDISC ODM Schema
MetaDataVersion

ODM Include

Protocol

Study StudyEventDef

FormDef
AdminData
ItemGroupDef
ReferenceData
ItemDef

ClinicalData CodeList

Presentation

ConditionDef

MethodDef

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© CDISC 2012
 Structure of Define-XML Metadata
MetaDataVersion

def:AnnotatedCRF Annotated case report forms

def:SupplementalDoc Reviewers guide

def:ValueListDef Value level metadata

def:WhereClauseDef Where clause definitions

ItemGroupDef Datasets

ItemDef Variable or value definitions

CodeList Controlled terminology

MethodDef Computational algorithms

def:CommentDef Comments

def:leaf Referenced documents

© CDISC 2012
 XSL – Extensible Stylesheet Language
• XSL is actually a combination of two standards:
 XML Transform
 XPATH
• XSL is a sophisticated transformation language with
many built in functions
• XPATH is a standard for specifying a location in an XML
document. Here are some examples:

Xpath Description
/Playlist/Song/Album Any Album element

/Playlist/Song/Album@Genre Genre attribute for Album element

/Playlist/Song/Album[@Genre=‘Rock’] Element for a Rock album

© CDISC 2012
 XSL – Extensible Stylesheet Language

• Requires a tool known as XSLT processor – included in

most browsers
• Can be used to display or transform XML files
• For Define-XML we use XSL to display the XML file as a
web page

XML Document New Document

XSLT
Processor

<?xml version="1.0"?> XSL Document

<xsl:stylesheet version="1.0“ ...
© CDISC 2012
Playlist Transformed by XSL

© CDISC 2012
Define-XML files Transformed using XSL

© CDISC 2012
 Topics

Introduction
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

36
Define-XML 2.0 Specification

© CDISC 2012
Datasets

© CDISC 2012
Dataset Metadata
• Every submitted tabulation and analysis dataset should be
described with metadata (i.e., data about the data):
 Dataset name
 Label - descriptive name
 Class – SDTM, ADaM or SEND class information
 Structure – organization of observation records
 Purpose – Tabulation or Analysis
 Keys
 Location – folder and filename for dataset file
 Documentation – annotated CRF, reviewers guide

© CDISC 2012 39
SDTM Dataset Metadata

© CDISC 2012
ADaM Dataset Metadata

© CDISC 2012
Dataset Metadata  ItemGroupDef
@ OID

@ Name

attributes
@ Repeating

@ IsReferenceData
ItemGroupDef
@ SASDatasetName

ItemRef @ Domain

@ Origin

Alias @ Role

@ Purpose

def:leaf @ Comment

@ def:Class

Description
@ def:Structure

@ def:ArchiveLocationID
 SDTM Dataset Metadata Example

1 2 3 5 7 8
4 6

<ItemGroupDef OID="IG.DM" Domain="DM"1Name="DM" Repeating="No" IsReferenceData="No"

SASDatasetName="DM"5 Purpose="Tabulation"4 def:Structure="One record per subject"
3 def:Class="SPECIAL PURPOSE" 8 def:CommentOID="COM.DOMAIN.DM"
7 def:ArchiveLocationID="LF.DM">
2 <Description>
<TranslatedText xml:lang="en">Demographics</TranslatedText>
</Description>
<ItemRef ItemOID="IT.STUDYID" OrderNumber="1" Mandatory="Yes" 6 KeySequence="1"/>
<ItemRef ItemOID="IT.DM.DOMAIN" OrderNumber="2" Mandatory="Yes"/>
<ItemRef ItemOID="IT.USUBJID" OrderNumber="3" Mandatory="Yes" 6 KeySequence="2” />
…
<ItemRef ItemOID="IT.DM.COUNTRY" OrderNumber="16" Mandatory="Yes"/>
<def:leaf ID="LF.DM" xlink:href="dm.xpt">
7
<def:title>dm.xpt</def:title>
</def:leaf>
</ItemGroupDef>
…
 ADaM Dataset Metadata Example

1
3 4 5
2

<ItemGroupDef OID="IG.ADQSADAS" Name="ADQSADAS" SASDatasetName="ADQSADAS" Repeating="Yes" IsReferenceData="No"

Purpose="Analysis" 5
3
4 def:Structure="One record per subject per parameter per analysis visit per analysis date" def:Class="BASIC DATA STRUCTURE"
def:CommentOID="COM.ADQSADAS"
def:ArchiveLocationID="LF.ADQSADAS">
<Description> 2
<TranslatedText xml:lang="en">ADAS-Cog Analysis</TranslatedText>
</Description>
<ItemRef ItemOID="IT.ADQSADAS.STUDYID" OrderNumber="1" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.SITEID" OrderNumber="2" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.SITEGR1" OrderNumber="3" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.USUBJID" OrderNumber="4" Mandatory="No" KeySequence="1"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTSDT" OrderNumber="5" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTEDT" OrderNumber="6" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTP" OrderNumber="7" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTPN" OrderNumber="8" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.AGE"
© CDISC 2012
OrderNumber="9" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.AGEGR1" OrderNumber="10" Mandatory="No"/>
 ADaM Dataset Metadata - Keys

1
2
3 4

<ItemRef ItemOID="IT.ADQSADAS.STUDYID" OrderNumber="1" Mandatory="No"/>

<ItemRef ItemOID="IT.ADQSADAS.SITEID" OrderNumber="2" Mandatory="No"/>
<ItemGroupDef OID="IG.ADQSADAS" Name="ADQSADAS"
<ItemRef ItemOID="IT.ADQSADAS.SITEGR1" SASDatasetName="ADQSADAS"
OrderNumber="3" Mandatory="No"/> Repeating="Yes" IsReferenceData="No"
Purpose="Analysis"
<ItemRef ItemOID="IT.ADQSADAS.USUBJID" OrderNumber="4" Mandatory="No" KeySequence="1"/>
def:Structure="One record per subject per parameter
<ItemRef ItemOID="IT.ADQSADAS.TRTSDT" per analysisMandatory="No"/>
OrderNumber="5" visit per analysis date" def:Class="BASIC DATA STRUCTURE"
def:CommentOID="COM.ADQSADAS"
…
def:ArchiveLocationID="LF.ADQSADAS">
<ItemRef ItemOID="IT.ADQSADAS.COMP24FL" OrderNumber="17" Mandatory="No"/>
<Description>
<ItemRef ItemOID="IT.ADQSADAS.AVISIT" OrderNumber="18" Mandatory="No" KeySequence="3"
<TranslatedText xml:lang="en">ADAS-Cog Analysis</TranslatedText>
MethodOID="MT.ADQSADAS.AVISIT"/>
</Description>
…
<ItemRef
<ItemRef ItemOID="IT.ADQSADAS.STUDYID" OrderNumber="1" Mandatory="No"/>
ItemOID="IT.ADQSADAS.AVISITN" OrderNumber="19" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.SITEID" OrderNumber="2"
<ItemRef ItemOID="IT.ADQSADAS.ADY" OrderNumber="22" Mandatory="No" Mandatory="No"/>
MethodOID="MT.ADQSADAS.ADY"/>
<ItemRef ItemOID="IT.ADQSADAS.ADT"
<ItemRef ItemOID="IT.ADQSADAS.SITEGR1" OrderNumber="3"
OrderNumber="23" Mandatory="No"/>
Mandatory="No" KeySequence="4"
<ItemRef ItemOID="IT.ADQSADAS.USUBJID"
MethodOID="MT.ADQSADAS.ADT"/> OrderNumber="4" Mandatory="No" KeySequence="1"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTSDT" OrderNumber="5" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.PARAM" OrderNumber="24" Mandatory="No"/>
<ItemRef
<ItemRef ItemOID="IT.ADQSADAS.TRTEDT"
ItemOID="IT.ADQSADAS.PARAMCD" OrderNumber="6"
OrderNumber="25"Mandatory="No"/>
Mandatory="No" KeySequence="2"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTP" OrderNumber="7" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.TRTPN" OrderNumber="8" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.AGE"
© CDISC 2012
OrderNumber="9" Mandatory="No"/>
<ItemRef ItemOID="IT.ADQSADAS.AGEGR1" OrderNumber="10" Mandatory="No"/>
ADaM Dataset Metadata - Location

<ItemGroupDef OID="IG.ADQSADAS" Name="ADQSADAS" SASDatasetName="ADQSADAS" Repeating="Yes" IsReferenceData="No"

Purpose="Analysis”
def:Structure="One record per subject per parameter per analysis visit per analysis date" def:Class="BASIC DATA STRUCTURE"
def:CommentOID="COM.ADQSADAS”
1 def:ArchiveLocationID="LF.ADQSADAS">
<Description> [Element Content]
<ItemRef ItemOID="IT.ADQSADAS.STUDYID" OrderNumber="1" Mandatory="No"/>
…
1 <def:leaf ID="LF.ADQSADAS" xlink:href="adqsadas.xpt">
<def:title>adqsadas.xpt </def:title>
</def:leaf>
</ItemGroupDef>

© CDISC 2012
ADaM Dataset Metadata - Comments

<ItemGroupDef OID="IG.ADQSADAS" Name="ADQSADAS" SASDatasetName="ADQSADAS" Repeating="Yes" IsReferenceData="No"

Purpose="Analysis”
def:Structure="One record per subject per parameter per analysis visit per analysis date" def:Class="BASIC DATA STRUCTURE"
2 def:CommentOID="COM.ADQSADAS”
def:ArchiveLocationID="LF.ADQSADAS">
<Description> [Elemment Content]
<ItemRef ItemOID="IT.ADQSADAS.STUDYID" OrderNumber="1" Mandatory="No"/>
…
</ItemGroupDef>

<def:CommentDef OID="COM.ADQSADAS">
<Description>
<TranslatedText>See referenced dataset creation program and Analysis Data Reviewer's Guide, Section 2.1</TranslatedText>
</Description>
<def:DocumentRef leafID="LF.ADQSADAS.PGM"/>
<def:DocumentRef leafID="LF.ADRG">
<def:PDFPageRef PageRefs="Section2.1" Type="NamedDestination"/>
</def:DocumentRef>
</def:CommentDef>
© CDISC 2012
SDTM Split Datasets
• Required when individual dataset size exceeds
1GB (FDA Common Issues Document)

• Recommended for Questionnaires

• Never used with ADaM

• Each dataset must be listed in the Define-XML

© CDISC 2012
SDTM Split Domain Datasets Example 1
 3
1
1 4

1
ItemGroup Name = SASDatasetName = root file name
2
Domain = parent Domain
3
Description = Dataset description/label
4
Alias (@DomainDescription) = Parent domain label
1
<ItemGroupDef OID="IG.QSCG” 2 Domain="QS” Name="QSCG” Repeating="Yes” IsReferenceData=”N”1 SASDatasetName="QSCG"
Purpose="Tabulation” def:Structure="One record per questionnaire per question per visit per subject"
def:Class="FINDINGS” def:CommentOID="COM.DOMAIN.QSCG"
1 def:ArchiveLocationID="LF.QSCG">
3 <Description>
<TranslatedText xml:lang="en">Questionnaire-QSCG</TranslatedText>
</Description>
…
4 <Alias Context="DomainDescription" Name="Questionnaires"/>
<def:leaf ID="LF.QSCG" 1 xlink:href="qscg.xpt">
<def:title>qscg.xpt</def:title>
</def:leaf>
</ItemGroupDef>
Dataset Summary
• For regulatory submissions, a Domain
specification is required for SDTM (and SEND)
datasets

• Split dataset conventions for SDTM are not

verified in current version of OpenCDISC validator

© CDISC 2012
Variables

© CDISC 2012
Variable-Level Metadata

• The Variable Name, which must follow the SDTM standards.

• A descriptive Variable Label, up to 40 characters, unique for each

variable in the dataset.

• The data Type (e.g., whether the variable value is a character or a

number).

• Controlled Terms or Format for the variable

 Where CDISC Controlled Terminology is available, the codelist is
specified; Follow the links, or see Appendix C

 Note the single asterisk for AEREL. The values for this variable are
subject to sponsor-defined controlled terminology

© CDISC 2012 53
Variable-Level Metadata

• The Role of the variable describes how the variable is used.

• Origin - information about the source or origin of the data (e.g.,

CRF, eDT, derived, assigned, protocol).

• Derivation – for derived variables the algorithm used to compute

data values.

• Comment – other information about the variable that may be useful

for the data reviewer. More lengthy comments may be in an
accompanying Reviewer Guide.

© CDISC 2012 54
SDTM Variable Metadata

© CDISC 2012
ADaM Variable Metadata
Variable Metadata  ItemRef/ItemDef
ItemGroupDef

ItemRef

ItemDef attributes
Alias

Description @ OID
def:leaf

@ Name
CodeListRef
Description

@ DataType
def:Origin

@ Length
def:ValueList

@ SignificantDigits

@ SASFieldName

@ def:DisplayFormt

@ def:CommentOID
SDTM Variable Metadata

© CDISC 2012
 SDTM Variables - ItemRef

<ItemGroupDef OID="IG.DM” Domain="DM” Name="DM” Repeating="No"

IsReferenceData="No” SASDatasetName="DM” Purpose="Tabulation"
def:Structure="One record per subject” def:Class="SPECIAL PURPOSE"
def:CommentOID="COM.DOMAIN.DM” def:ArchiveLocationID="LF.DM">
<Description> [Element content]
<ItemRef ItemOID="IT.STUDYID" OrderNumber="1" Mandatory="Yes" KeySequence="1"/>
<ItemRef ItemOID="IT.DM.DOMAIN" OrderNumber="2" Mandatory="Yes"/>
<ItemRef ItemOID="IT.USUBJID" OrderNumber="3" Mandatory="Yes" KeySequence="2" Metho
<ItemRef ItemOID="IT.DM.SUBJID" OrderNumber="4" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.RFSTDTC" OrderNumber="5" Mandatory="No" MethodOID="MT.RF
<ItemRef ItemOID="IT.DM.RFENDTC" OrderNumber="6" Mandatory="No" MethodOID="MT.RF
<ItemRef ItemOID="IT.DM.SITEID" OrderNumber="7" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.BRTHDTC" OrderNumber="8" Mandatory="No"/>
<ItemRef ItemOID="IT.DM.AGE" OrderNumber="9" Mandatory="Yes" MethodOID="MT.AGE"/>
<ItemRef ItemOID="IT.DM.AGEU" OrderNumber="10" Mandatory="No"/>
<ItemRef ItemOID="IT.DM.SEX" OrderNumber="11" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.RACE" OrderNumber="12" Mandatory="No"/>
<ItemRef ItemOID="IT.DM.ETHNIC" OrderNumber="13" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.ARMCD" OrderNumber="14" Mandatory="Yes"/>
© CDISC 2012
 SDTM Variables – Item Def

1 2 3 4 5

1 3 4
<ItemDef OID="IT.STUDYID" Name="STUDYID" DataType="text" Length="7" SASFieldName="STUDYID">
<Description>
2
<TranslatedText xml:lang="en">Study Identifier</TranslatedText>
</Description> 5
<def:Origin Type="Protocol"/>
</ItemDef>

© CDISC 2012
 ADaM Variables - ItemDef

5
1 2 3 4

1
<ItemDef OID="IT.ADSL.DISONSDT" Name="DISONSDT" SASFieldName="DISONSDT"
3 DataType="integer" Length="8" 4 def:DisplayFormat="date9.">
<Description> 2
<TranslatedText xml:lang="en">Date of Onset of Disease</TranslatedText>
</Description>
5<def:Origin Type="Derived"/>
</ItemDef>
Define-XML DataType Submission Length/Format
(example) DataType
text Char Maximum allowable length
(hematocrit)
integer Num Largest allowable integer width. Note
(160) that ADaM date variables are
provided as integers
float Num Use when value has a fractional
(57.5) component.
datetime Char ISO8601
(2013-10-02T10:30:25) YYYY-MM-DDTHH:MM:SS[.SS]
date Char ISO8601 YYYY-MM-DD
(2013-10-02)
time Char ISO8601 HH24:MM:SS[.SS]
(10:30:25)
partialDateTime Char ISO8601 YYYY[-MM[-
(2013-10-02T10:30) DD]]THH24[:MM[:SS[.SS]]]
incompleteDatetime Char [YYYY-]-[MM-]-[DD-
(10-02T10) ]T[HH24:][:MM:][SS.][SS]
durationDatetime Char ISO8610 [-]PHH:MM:SS
(-P02:15) © CDISC 2012
 Translating Data Types

SDTM, ADaM SEND data type conversions to ODM data type in

Define.xml

• SDTM • Define.xml

 Num  integer
 float
 Char  text
 Char (ISO8601)  date
 datetime
 time

© CDISC 2012 63
 Data Type Considerations
• ItemDef Length attribute is required when
DataType is text, integer or float

• ItemDef SignificantDigits attribute is required for

float variables

Note
• It is invalid to use the Length attribute with other
data types.

© CDISC 2012
Exercise 1

© CDISC 2012
Exercise 1 Instructions
1. Locate Exercises Folder in course materials
(USB)
2. Copy folder to desktop
3. Navigate to Exercises Folder and locate
Exercises spreadsheet.
4. Open spreadsheet using Excel
5. Save a copy of the worksheet to desktop
6. Click on TOC tab
7. Click on Datasets and Variables link.

Follow steps.
(optional) Use the Notes column to record any
questions and notes as you complete each step.
© CDISC 2012
Origin/Source

© CDISC 2012
SDTM Origin

© CDISC 2012
 SDTM Annotated CRF Links – def:Origin

<ItemDef OID="IT.AE.AEACN" Name="AEACN" DataType="text" Length="30" SASFieldName="AEACN">

<Description>
<TranslatedText xml:lang="en">Action Taken with Study Treatment</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.ACN"/>
<def:Origin Type="CRF">
<def:DocumentRef leafID="LF.blankcrf">
<def:PDFPageRef PageRefs="21" Type="PhysicalRef"/>
</def:DocumentRef>
</def:Origin>
</ItemDef>

<def:leaf ID="LF.blankcrf" xlink:href="blankcrf.pdf">

<def:title>Annotated Case Report Form</def:title>
</def:leaf>

© CDISC 2012
 Annotated CRF <def:AnnotatedCRF>
<def:DocumentRef leafID="LF.acrf"/> 3
1 </def:AnnotatedCRF>

<ItemDef OID="IT.CM.CMTRT" Name=“CMTRT" DataType="text" Length=“23" SASFieldName=“CMTRT">

<Description>
<TranslatedText xml:lang="en">Reported Name of Drug, Med or Therapy</TranslatedText>
</Description>
<def:Origin Type="CRF">
<def:DocumentRef leafID="LF.acrf">
<def:PDFPageRef PageRefs=“9 22" Type="PhysicalRef"/> 3
</def:DocumentRef>
</def:Origin>
</ItemDef>

<def:leaf ID="LF.acrf" xlink:href=“aCRF.pdf">

<def:title>Annotated Case Report Form</def:title>
</def:leaf>

© CDISC 2012
 def:Origin Types
Allowable Values Context/Comments
CRF SDTM - Data collected on CRF
Derived SDTM & ADaM - Data value calculated from
other data values
Assigned SDTM & ADaM - Data values set independent
of subject related data values (e.g. Domain)
Protocol SDTM - Data values defined in the study
protocol
eDT SDTM - Data received via electronic data
transfer
Predecesser SDTM & ADaM - Data value is a direct copy of
a variable in another dataset

Note that def:Origin may be provided at the Variable or Value level.

© CDISC 2012
ADaM Source – def:Origin

© CDISC 2012
 ADaM Source - Assigned

<ItemDef OID="IT.ADQSADAS.AVISITN" Name="AVISITN" SASFieldName="AVISITN"

DataType="integer" Length="8" def:CommentOID="COM.ADQSADAS.AVISITN">
<Description>
<TranslatedText xml:lang="en">Analysis Visit (N)</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.AVISITN"/>
<def:Origin Type="Assigned"/>
</ItemDef>

<def:CommentDef
OID="COM.ADQSADAS.AVISITN">
<Description>
<TranslatedText>Numeric code for
AVISIT</TranslatedText>
</Description>
</def:CommentDef>

© CDISC 2012
 ADaM Source -
Predecessor

<ItemDef OID="IT.ADQSADAS.USUBJID" Name="USUBJID" SASFieldName="USUBJID"

DataType="text" Length="11">
<Description>
<TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL.USUBJID</TranslatedText>
</Description>
</def:Origin>
</ItemDef>

© CDISC 2012
 <ItemGroupDef OID="IG.ADQSADAS" Name="ADQSADAS" SASDatasetName="ADQSADAS" Repeating="Yes"
IsReferenceData="No" Purpose="Analysis"
def:Structure="One record per subject per parameter per analysis visit per analysis date" def:Class="BASIC DATA
ADaM Source – Derived
STRUCTURE" def:CommentOID="COM.ADQSADAS"
def:ArchiveLocationID="LF.ADQSADAS">
<Description>
<TranslatedText xml:lang="en">ADAS-Cog Analysis</TranslatedText>
</Description>
<ItemRef ItemOID="IT.ADQSADAS.STUDYID" OrderNumber="1" Mandatory="No"/>
…
<ItemRef ItemOID="IT.ADQSADAS.AVISIT" OrderNumber="18" Mandatory="No" KeySequence="3"
MethodOID="MT.ADQSADAS.AVISIT"/>
…
Note that the reference to the
</ItemGroupDef> derivation definition (method) is
from the ItemRef.
<ItemDef OID="IT.ADQSADAS.AVISIT" Name="AVISIT" SASFieldName="AVISIT" DataType="text" Length="16">
<Description>
<TranslatedText xml:lang="en">Analysis Visit</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.AVISIT"/>
<def:Origin Type="Derived"/>
</ItemDef>

<MethodDef OID="MT.ADQSADAS.AVISIT" Name="CM.ADQSADAS.AVISIT" Type="Computation">

<Description>
<TranslatedText xml:lang="en">Derived based on windowing algorithm described in SAP, Section 8.2</TranslatedText>
</Description>
</MethodDef>

© CDISC 2012
Exercise 2
1. Locate workbook saved from Exercise 1
2. Open (if not already opened)
3. Click on Exercise 2 tab (or use TOC)
4. Follow steps.
 You are changing the Origin type for AGEGR1N to be
Derived (it starts out as Comment).
 This involves changing the Origin in the Variables tab
and adding a row in the Methods tab.

• You will use the html file in the Define-

Examples/adam folder and the ADaM Metadata
Worksheet in the Exercises folder.
• Save a copy of the worksheet at the end.
© CDISC 2012
Controlled Terminology

© CDISC 2012
Controlled Terminology Types
• Enumerations

• Codelists

• Dictionary References

© CDISC 2012
Controlled Terminology Examples

Enumeration

Enumeration

CodeList

External Dictionaries

© CDISC 2012
 Define-XML CodeList Components

attributes
CodeList
attributes @ OID
EnumeratedItem @ CodedValue
@ Name
@Rank
Alias @ DataType
@Order
attributes @ SASFormatName

CodeListItem @ CodedValue

@Rank

Decode
@Order
OR
TranslatedText
Alias

ExternalCodeList

Alias
81
© CDISC 2012
1 Enumeration Example

<CodeList OID="CL.AEREL" Name="Causality" DataType="text">

<EnumeratedItem CodedValue="NOT RELATED"/>
2 <EnumeratedItem CodedValue="POSSIBLY RELATED"/>

<EnumeratedItem CodedValue="RELATED"/>
</CodeList>

© CDISC 2012
 1
Codelist Example
2

<CodeList OID="CL.ARMCD" Name="Planned Arm Code" DataType="text” >

<CodeListItem CodedValue="PLACEBO" OrderNumber=“3"> 3
<Decode>
<TranslatedText xml:lang="en">Placebo</TranslatedText>
</Decode> OrderNumber
</CodeListItem> indicates display
<CodeListItem CodedValue="SCRNFAIL" OrderNumber=“4">
<Decode>
4 order.
<TranslatedText xml:lang="en">Screen Failure</TranslatedText>
</Decode>
</CodeListItem>
1
<CodeListItem CodedValue="WONDER10" OrderNumber="1">
<Decode>
<TranslatedText xml:lang="en">Miracle Drug 10 mg</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="WONDER20" OrderNumber="2"> 2
<Decode>
<TranslatedText xml:lang="en">Miracle Drug 20 mg</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
© CDISC 2012
 Dictionary Reference Example

<CodeList OID="CL.AEDICT_F" Name="Adverse Event Dictionary" DataType="text">

<ExternalCodeList Dictionary="MEDDRA" Version="8.0"/>
</CodeList>
<CodeList OID="CL.DRUGDICT_F" Name="Drug Dictionary" DataType="text">
<ExternalCodeList Dictionary="WHODRUG" Version="200204"/>
</CodeList>
<CodeList OID="CL.ISO3166" Name="ISO3166" DataType="text">
<ExternalCodeList Dictionary="ISO3166" Version=" "/>
</CodeList>

© CDISC 2012
Codelists vs. Enumerations
SDTM variables for coded values should use Define-
XML CodeList element:

© CDISC 2012
ADaM XXXN Variables should use Define-XML
Codelist element.

Enumeration

Codelist
XSL Stylesheet uses Decode value from Codelist.
 CDISC Controlled Terminology
• CDISC Controlled Terminology (CT) is defined for
many SDTM variables, for a few ADaM variables
 Maintained in the US National Cancer Institute (NCI)
Enterprise Vocabulary System
• For SDTM where there is a CDISC defined
Controlled Vocabulary, cross-references to the
relevant NCI codes should be provided in
codelists using the ODM Alias element.
 Context attribute must be nci:ExtCodeID
• Some CDISC CTs are Extensible meaning
sponsor may add new terms
 New terms should only be added if they are distinct in
meaning from the existing terms.

88
© CDISC 2012
CDISC Controlled Terminology

© CDISC 2012
 CDISC Controlled Terminology Support

<CodeList OID="CL.AESEV" Name="Severity/Intensity Scale for Adverse Events" DataType="text"

SASFormatName="$AESEV">
<CodeListItem CodedValue="MILD" Rank="1">
<Decode>
<TranslatedText xml:lang="en">Grade 1</TranslatedText>
</Decode>
<Alias Name="C41338" Context="nci:ExtCodeID"/>
</CodeListItem> Use Alias elements for
<CodeListItem CodedValue="MODERATE" Rank="2">
<Decode> CDISC Controlled
<TranslatedText xml:lang="en">Grade 2</TranslatedText> Terminology C-Codes
</Decode>
<Alias Name="C41339" Context="nci:ExtCodeID"/>
</CodeListItem>
<CodeListItem CodedValue="SEVERE" Rank="3">
<Decode>
<TranslatedText xml:lang="en">Grade 3</TranslatedText>
</Decode>
Alias for Codelist C-code
<Alias Name="C41340" Context="nci:ExtCodeID"/> comes after all coded
</CodeListItem>
<Alias Name="C66769" Context="nci:ExtCodeID"/>
values
</CodeList>
© CDISC 2012
 CDISC Controlled Terminology Support

<CodeList OID="CL.AESEV" Name="Severity/Intensity Scale for Adverse Events"

DataType="text" SASFormatName="$AESEV">
<CodeListItem CodedValue="MILD" Rank="1">
<Decode>
<TranslatedText xml:lang="en">Mild Adverse Event</TranslatedText>
</Decode>
<Alias Name="C41338" Context="nci:ExtCodeID"/> Use
</CodeListItem> Decode/TranslatedText
<CodeListItem CodedValue="MODERATE" Rank="2">
<Decode> for Display Value text.
<TranslatedText xml:lang="en">Moderate Adverse Event</TranslatedText>
</Decode>
<Alias Name="C41339" Context="nci:ExtCodeID"/>
</CodeListItem>
<CodeListItem CodedValue="SEVERE" Rank="3">
<Decode>
<TranslatedText xml:lang="en">Severe Adverse Event</TranslatedText>
</Decode>
<Alias Name="C41340" Context="nci:ExtCodeID"/>
</CodeListItem>
<Alias Name="C66769" Context="nci:ExtCodeID"/>
</CodeList> © CDISC 2012
 CDISC Controlled Terminology - Enumeration

<CodeList OID="CL.DISCCD" Name="Completion/Reason for Non-Completion" DataType="text">

<EnumeratedItem CodedValue="COMPLETED" OrderNumber="1">
<Alias Name="C25250" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="ADVERSE EVENT" OrderNumber="2">
<Alias Name="C41331" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="DEATH" OrderNumber="3">
<Alias Name="C28554" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="LACK OF EFFICACY" OrderNumber="4">
 Controlled Terminology Extension Example

<CodeList OID="CL.CMUNIT" Name="Unit (CM)" DataType="text">

<EnumeratedItem CodedValue="CAPSULE" OrderNumber="1">
<Alias Name="C48480" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="IU" OrderNumber="2">
<Alias Name="C48579" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="mL/hr" OrderNumber="7" def:ExtendedValue="Yes"/>
<EnumeratedItem CodedValue="TABLET" OrderNumber="3">
<Alias Name="C48542" Context="nci:ExtCodeID"/>
</EnumeratedItem>
ADaM Controlled Terminology

© CDISC 2012
ADaM Controlled Terminology
Examples

© CDISC 2012
Exercise 3
1. Click on Exercise 3 in Exercise workbook.
2. Follow the steps.

• You will modify the codelist definitions so that

each of the QCXX split domains references a
separate codelist for the QSTESTCD and
QSTEST variables.
• You will use the Codelists and Variables tabs in
the SDTM-Metadata-Workbook excel file.

© CDISC 2012
Comments

© CDISC 2012
 Comments
Comments may be added to dataset, variable and
value level metadata.
Comments should not be used to store information
about computational algorithms/derivations.

<ItemGroupDef OID="IG.DM” Domain="DM” Name="DM” Repeating="No” IsReferenceData="No"

SASDatasetName="DM” Purpose="Tabulation” def:Structure="One record per subject"
def:Class="SPECIAL PURPOSE” 1 def:CommentOID="COM.DOMAIN.DM” def:ArchiveLocationID="LF.DM">
<Description>
<TranslatedText xml:lang="en">Demographics</TranslatedText>
</Description>
…
</ItemGroupDef>

© CDISC 2012
 def:CommentDef Components

MetaDataVersion
attributes

ItemGroupDef @def:CommentOID

attributes
ItemDef
@def:CommentOID

attributes
def:CommentDef @OID

Description

def:DocumentRef

99
© CDISC 2012
Where Can Comments Be Added?
Metadata XML Element Usage
Component
Dataset definition ItemGroupDef Domain level
explanations
Variable definition ItemDef -Variable level
explanations
- Describes Origin
when OriginType is
Assigned
Value definition ItemDef Value level
explanations
VLM Where Clause def:WhereClauseDef Describe join between
two datasets

© CDISC 2012
 Comments with Links to External Documents

1
2

<ItemDef
1 def:CommentOID="COM.ARMCD">
OID="IT.DM.ARMCD" Name="ARMCD" DataType="text" Length="8" SASFieldName="ARMCD"
<Description>
<TranslatedText xml:lang="en">Planned Arm Code</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.ARMCD"/>
<def:Origin Type="Assigned"/>
</ItemDef>

<def:CommentDef OID="COM.ARMCD">
<Description>
2 <TranslatedText xml:lang="en">Assigned based on Randomization Number. See Note 2.1</TranslatedText>
</Description>
3 <def:DocumentRef leafID="LF.ReviewersGuide"/>
</def:CommentDef>

3 <def:leaf ID="LF.ReviewersGuide" xlink:href="reviewersguide.pdf">

<def:title>Reviewers Guide</def:title>
</def:leaf>
 Reviewers’ Guide (SDTM)

<def:SupplementalDoc>
1 <def:DocumentRef leafID="LF.ReviewersGuide"/>
<def:DocumentRef leafID="LF.ComplexAlgorithms"/>
</def:SupplementalDoc>

<def:leaf ID="LF.ReviewersGuide" xlink:href="reviewersguide.pdf">

<def:title>Reviewers Guide</def:title>
2
</def:leaf>

© CDISC 2012
Exercise 4
1. Click on Exercise 4 tab in Exercise Workbook.
2. Follow the steps.
3. The first 9 steps will guide you as you browse the
ADaM Define-XML display.
4. The remaining steps will guide you through
setting up references to specific pages in the
SDTM Reviewers’ guide for the TI and TS
datasets.

The page references in Comments will appear as

hyperlinks in the SDTM Define-XML display. The
hyperlinks should take you to the page 4 in the
STDM Reviewers’ Guide.
© CDISC 2012
Value Level Metadata

© CDISC 2012
Value Level Metadata
The SDTM domain models are highly normalized
data structures. As a result there are some cases
where the contents of a column or variable cannot
be unambiguously defined through Variable
Metadata.

© CDISC 2012
 Vital Signs Example

Vital Signs data typically includes observations

that naturally have different data types.
 Concomitant Medications Example

Origin of CMINDC is derived for medications

taken during the study but Assigned for
medications stopped prior to the study start.
ADaM Parameter Level Metadata
• In the ADaM BDS structure, the metadata for the
Analysis Value (AVAL) as well as for other
variables such as Derivation Type (DTYPE) may
be parameter dependent.

108
© CDISC 2012
Define-XML 2.0 Value Level Metadata
• Value Level Metadata is usually attached to
XXSTRESN or XXORRES but may be attached to
any SDTM variable whose values should be
interpreted differently depending on other
variables.

• All variable metadata components are available at

the value level
 DataType
 CodeLists
 Length/Significant Digits
 Format
 Origin
 Comments 109
© CDISC 2012
Define-XML 2.0 Value Level Metadata
• Each Value Level Metadata definition includes a
WhereClause. The WhereClause defines the
conditions where the definition applies.
Variable Where
VSSTRESN VSTESTCD IN (SYSBP,
DIABP, PULSE)
VSSTRESN VSTESTCD IN (WEIGHT,
HEIGHT, BMI)

Variable Where
QSSEQ PARAM IN NOTIN
(“ACTOT”)
QSSEQ PARAM EQ ACTOT

110
© CDISC 2012
Representing Value Level Metadata

© CDISC 2012
Representing Value Level Metadata

<def:ValueListDef OID="VL.VS.VSORRESU">
<ItemRef ItemOID="IT.VS.VSORRESU.HEIGHT.DM.COUNTRY.CMETRIC"
OrderNumber="1" Mandatory="Yes">
<def:WhereClauseRef
WhereClauseOID="WC.VS.VSTESTCD.HEIGHT.[DM].COUNTRY.CMETRIC"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU.HEIGHT.DM.COUNTRY.CNMETRIC“
OrderNumber="2" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.HEIGHT.[DM].COUNTRY.CNMETRIC
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU.WEIGHT.DM.COUNTRY.CMETRIC"
OrderNumber="3" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.WEIGHT.[DM].COUNTRY.CMETRIC"
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU.WEIGHT.DM.COUNTRY.CNMETRIC"
OrderNumber="4" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.WEIGHT.[DM].COUNTRY.CNMETRIC
</ItemRef>
</def:ValueListDef>

© CDISC 2012
Each Value Definition Includes a
WhereClause

<def:ValueListDef OID="VL.VS.VSORRESU">
<ItemRef ItemOID="IT.VS.VSORRESU.HEIGHT.DM.COUNTRY.CMETRIC"
OrderNumber="1" Mandatory="Yes">
<def:WhereClauseRef
WhereClauseOID="WC.VS.VSTESTCD.HEIGHT.[DM].COUNTRY.CMETRIC"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU.HEIGHT.DM.COUNTRY.CNMETRIC“
OrderNumber="2" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.HEIGHT.[DM].COUNTRY.CN
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU.WEIGHT.DM.COUNTRY.CMETRIC"
OrderNumber="3" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.WEIGHT.[DM].COUNTRY.CM
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU.WEIGHT.DM.COUNTRY.CNMETRIC"
OrderNumber="4" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.WEIGHT.[DM].COUNTRY.CN
</ItemRef>
</def:ValueListDef>

© CDISC 2012
Value Level Details

<ItemDef OID="IT.VS.VSORRESU.HEIGHT.DM.COUNTRY.CNMETRIC" Name="VS.HE

DataType="text" Length="5" SASFieldName="HEIGHTU">
<Description>
<TranslatedText xml:lang="en">Height: Original Units</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.UH_NMC"/>
<def:Origin Type="CRF">
<def:DocumentRef leafID="LF.blankcrf">
<def:PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</def:DocumentRef>
</def:Origin>
© CDISC 2012
</ItemDef>
Where Clause Details

<def:WhereClauseDef OID="WC.VS.VSTESTCD.HEIGHT.[DM].COUNTRY.CNMETRIC
def:CommentOID="COM.SUBJECTDATA-JOIN-DM">
<RangeCheck SoftHard="Soft" def:ItemOID="IT.VS.VSTESTCD" Comparator="EQ
<CheckValue>HEIGHT</CheckValue>
</RangeCheck>
<RangeCheck SoftHard="Soft" def:ItemOID="IT.DM.COUNTRY" Comparator="EQ
<CheckValue>USA</CheckValue>
</RangeCheck>
</def:WhereClauseDef>

© CDISC 2012
Where Clause Details

<def:WhereClauseDef OID="WC.VS.VSTESTCD.HEIGHT.[DM].COUNTRY.CNMETRIC
def:CommentOID="COM.SUBJECTDATA-JOIN-DM">
<def:CommentDef<RangeCheck SoftHard="Soft" def:ItemOID="IT.VS.VSTESTCD" Comparator="EQ
OID="COM.SUBJECTDATA-JOIN-DM">
<CheckValue>HEIGHT</CheckValue>
<Description>
</RangeCheck>
<TranslatedText xml:lang="en">Join any Subject Level dataset with the Demographics da
on <RangeCheck SoftHard="Soft" def:ItemOID="IT.DM.COUNTRY" Comparator="EQ
<CheckValue>USA</CheckValue>
[IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of t
ItemGroupDef </RangeCheck>
that defines the
subject-level</def:WhereClauseDef>
dataset to be joined with the Demographics dataset.</TranslatedText>
</Description>
</def:CommentDef>
© CDISC 2012
 Adding Value Level MetaData to a
Variable

<ItemDef OID="IT.VS.VSORRES" Name="VSORRES" DataType="text" Length="30"

SASFieldName="VSORRES">
<Description>
<TranslatedText xml:lang="en">Result or Finding in Original Units</TranslatedText>
</Description>
<def:Origin Type="CRF">
<def:DocumentRef leafID="LF.blankcrf">
<def:PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</def:DocumentRef>
</def:Origin>
<def:ValueListRef ValueListOID="VL.VS.VSORRES"/>
</ItemDef>
© CDISC 2012
 ValueListRef/Def Structure
ItemDef
attributes
def:ValueListRef
ValueListOID

attributes
def:ValueListDef
OID

attributes ItemOID
ItemRef

attributes
def:WhereClauseRef
1.. WhereClauseOID

attributes OID
def:WhereClauseDef
attributes
RangeCheck
def: ItemOID

CheckValue Comparator
118
© CDISC 2012
Value Level Metadata - ADaM

© CDISC 2012
 Value Level Metadata – ItemDef

<def:ValueListDef OID="VL.SC.SCORRES">
<ItemRef ItemOID="IT.SC.SCORRES.EDLEVEL" OrderNumber="1" Mandatory="No">
<def:WhereClauseRef WhereClauseOID="WC.SC.SCTESTCD.EDLEVEL"/>
</ItemRef>
<ItemRef
<ItemDef ItemOID="IT.SC.SCORRES.MARISTAT"
OID="IT.SC.SCORRES.EDLEVEL" OrderNumber="2"
Name="SC.EDLEVEL" Mandatory="No">
DataType="text" Length="24"
<def:WhereClauseRef
SASFieldName="EDLEVEL"> WhereClauseOID="WC.SC.SCTESTCD.MARISTAT"/>
</ItemRef>
<Description>
<ItemRef ItemOID="IT.SC.SCORRES.SUBJINIT"
<TranslatedText OrderNumber="3" Mandatory="No">
xml:lang="en">Education Level</TranslatedText>
<def:WhereClauseRef WhereClauseOID="WC.SC.SCTESTCD.SUBJINIT"/>
</Description>
</ItemRef> CodeListOID="CL.EDLEVEL"/>
<CodeListRef
</def:ValueListDef>
<def:Origin Type="CRF">
<def:DocumentRef leafID="LF.blankcrf">
<def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
</def:DocumentRef>
</def:Origin>
</ItemDef>

© CDISC 2012
 Value Level Metadata def:WhereClauseRef

<def:ValueListDef OID="VL.SC.SCORRES">
<ItemRef ItemOID="IT.SC.SCORRES.EDLEVEL" OrderNumber="1" Mandatory="No">
<def:WhereClauseRef WhereClauseOID="WC.SC.SCTESTCD.EDLEVEL"/>
</ItemRef>
</def:ValueListDef>
<def:WhereClauseDef OID="WC.SC.SCTESTCD.EDLEVEL">
<RangeCheck SoftHard="Soft" def:ItemOID="IT.SC.SCTESTCD" Comparator="EQ">
<CheckValue>EDLEVEL</CheckValue>
</RangeCheck>
</def:WhereClauseDef>

© CDISC 2012
 ADaM Parameter/Value Level Metadata

<def:ValueListDef OID="VL.ADQSADAS.DTYPE">
<ItemRef ItemOID="IT.ADQSADAS.DTYPE.ACITM01-ACITM14" Mandatory="No">
<def:WhereClauseRef WhereClauseOID="WC.ADQSADAS.DTYPE.ACITM01-ACITM14"/>
</ItemRef>
<ItemRef ItemOID="IT.ADQSADAS.DTYPE.ACTOT" Mandatory="No">
<def:WhereClauseRef WhereClauseOID="WC.ADQSADAS.DTYPE.ACTOT"/>
</ItemRef>
</def:ValueListDef>

<def:WhereClauseDef OID="WC.ADQSADAS.DTYPE.ACITM01-ACITM14">
<RangeCheck Comparator="NOTIN" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.PARAMCD">
<CheckValue>ACTOT</CheckValue>
</RangeCheck>
</def:WhereClauseDef>

<def:WhereClauseDef OID="WC.ADQSADAS.DTYPE.ACTOT">
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.PARAMCD">
<CheckValue>ACTOT</CheckValue>
</RangeCheck>
</def:WhereClauseDef>
© CDISC 2012
ADaM Parameter/Value Level Metadata

<ItemDef OID="IT.ADQSADAS.DTYPE.ACITM01-ACITM14" Name="DTYPE" SASFieldName="DTYPE"

DataType="text" Length="10" def:CommentOID="COM.ADQSADAS.DTYPE.ACITM01-ACITM14">
<Description>
<TranslatedText xml:lang="en">Derivation Type</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.DTYPE"/>
<def:Origin Type="Assigned"/>
</ItemDef>
<ItemDef OID="IT.ADQSADAS.DTYPE.ACTOT" Name="DTYPE" SASFieldName="DTYPE" DataType="text"
Length="10" def:CommentOID="COM.ADQSADAS.DTYPE.ACTOT">
<Description>
<TranslatedText xml:lang="en">Derivation Type</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.DTYPE"/>
<def:Origin Type="Assigned"/>
</ItemDef>

© CDISC 2012
Exercise 5
1. Select Exercise 5 tab in Exercise workbook.
2. In steps 1-5 you will view VLM for LBORRES.
3. In the remaining steps you will add VLM for
LBSTRESN.

© CDISC 2012
 Topics

Introduction to Define-XML
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

125
 What is Dataset-XML?
• Standard for transmission of datasets using XML
• Alternative to SAS Version 5 Transport (XPT) format
• ODM based model for representation of SEND,
SDTM, ADaM or legacy datasets.

126
© CDISC 2012
 Protocol CDASH SDTM ADaM

Study Design Lab SEND

Define-XML
SDM-XML
SDM-XML ODM
ODM Define-XML
Dataset-XML

Glossary
Therapeutic Areas
BRIDG

SHARE Questionnaires

Controlled Terminology Healthcare Link

© CDISC 2012
 SEND SDTM ADaM SEND SDTM ADaM
Metadata Metadata Metadata Data Data Data

Define- Dataset-
XML XML

ODM
128
© CDISC 2012
Define-XML

Dataset-XML
Define-XML provides Dataset-XML Metadata

© CDISC 2012
Datasets

© CDISC 2012
 ODM Model
attributes
ODM
@ Description

@ FileType
Study MetaData @ Granularity

@ Archival
AdminData
@ FileOID

ReferenceData @ CreationDateTime

@ PriorFileOID
ClinicalData Data & Audit @ AsOfDateTime
@ ODMVersion
Association @ Originator

@ SourceSystem
ds:signature
@ SourceSystemVersion

@ ID
133
© CDISC 2012
 ODM Model
attributes
ODM
@ Description

@ FileType
Study Define-XML @ Granularity

@ Archival
AdminData
@ FileOID

ReferenceData @ CreationDateTime

@ PriorFileOID
ClinicalData Dataset-XML @ AsOfDateTime
@ ODMVersion
Association @ Originator

@ SourceSystem
ds:signature
@ SourceSystemVersion

@ ID
134
© CDISC 2012
 ODM MetaData
MetaDataVersion
attributes
Include
@ OID
Protocol
@ Name
StudyEventDef
@ Description
FormDef

ItemGroupDef

ItemDef

CodeList

Presentation

ConditionDef

MethodDef

135
© CDISC 2012
 ODM Data
SubjectData

attributes
Audit

Signature @ SubjectKey

InvestigatorRef @ TransactionType

SiteRef Audit
Annotation Signature

Annotation
StudyEventData Audit

FormData Signature

ArchiveLayoutRef

Annotation Audit

Signature
ItemGroupData Annotation

ItemData

136
© CDISC 2012
 CDISC “end-to-end” process
CRO Sponsor

SDTM+/-

Investigator

Subject LABs

137
 CDISC “end-to-end” process
CRO Sponsor

SDTM+/- Archive
ODM

Investigator

Subject LABs

138
Dataset-XML
V1 Development Goals:
• Keep it simple
• Primary use case is transport
 Dataset-XML is intended to be a transport format
 1-1 replacement for XPT – 1 file per SEND or SDTM
domain or per ADaM dataset
 Requires no change to content standards
• Facilitate “apples-to-apples” FDA Pilot
• Require minimal additional effort for sponsors
 Sponsors develop SDTM or ADaM datasets as usual
then convert to XML (vs. convert to XPT)

© CDISC 2012
“Like all magnificent things, it’s very
simple.”
- Natalie Babbett, Tuck Everlasting

© CDISC 2012
“Nature is pleased with simplicity. And
nature is no dummy”
- Isaac Newton

© CDISC 2012
One xml file per dataset

© CDISC 2012
ClinicalData

SubjectData

StudyEvent

Form
Dataset-XML Data
ItemGroup

ClinicalData Item

ItemGroup
Item

143
© CDISC 2012
 144
© CDISC 2012
SDS-XML Sample

145
© CDISC 2012
Transport Use Case

© CDISC 2012
Transport Format vs. Operational
Format
• Transport Format is optimized for transmission of
data between organizations
 Dataset-XML further specialized for regulatory
submission use case
• Platform independent
• Vendor neutral

• Operational Format (ODM, SAS Datasets,

OracleDatabases) are optimized to provide
flexibility and efficiency across a wide range of
functional areas
 Data collection and cleaning
 Statistical analysis
 21 CFR Part 11 controls
© CDISC 2012
 Dataset-XML Use Case Example
• Case 1: Dataset-XML for data exchange
Sponsor Regulatory Agency

Review Tools Analysis Programs Review Tools Analysis Programs

Native Dataset Dataset Native

Format -XML -XML Format

Meta Define- Define- Meta

data XML XML data

Archive Archive

© CDISC 2012 148

© CDISC 2014
© CDISC 2014 150
http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM443327.pdf

© CDISC 2014
 FDA Pilot Test Methodology
1. Sponsor converts the original Phase 3 SDTM and ADaM (if
available) XPT datasets into DS-XML format with Define.xml
and sends them to the FDA (Batch 1).
2. Sponsor modifies the original Phase 3 SDTM SAS dataset to
contain longer variable names, labels, and text fields. Sponsor
then converts the new extended (modified) SAS dataset into
DS-XML format and sends them with Define.xml to the FDA
(Batch 2).
3. FDA performs a Data Processing Test on Batch 1 and Batch
2 by converting the XML datasets into .sas7bdat.
4. FDA performs a Data Matching Test on Batch 1 by
comparing the converted SDTM and ADaM SAS datasets (from
XML) with the converted SDTM and ADaM SAS datasets (from
XPT) using PROC COMPARE. FDA also performs a Data
Matching Test on Batch 2 by comparing the
converted SDTM SAS dataset (from XML) with the original
SDTM© CDISC
SAS 2014 dataset using PROC
© CDISC 2014
© CDISC 2014
 Benefits of a CDISC Dataset XML Standard
• Open, non-proprietary standard without field width or
variable naming restrictions of SAS V5 Transport files.
• Supports FDA goal of encouraging open source reviewer
tool development.
• Harmonized with BRIDG, CDISC Controlled Terminology.
• Supports representation of data relationships, metadata
versions and audit trails.
 Note: not all of these will be available in the first release.
• Data elements include references to metadata in Define-
XML.
• Straightforward implementation starting from SDTM data
in SAS or Oracle.

155
© CDISC 2014
How Dataset-XML Improves Submissions
• Short term – quick wins
 Provides XPT functionality without 1980’s limitations
• 8 character variable names
• 200 character text variables
 Enables tighter link with Define-XML
• Improved validation capabilities
• Long term
 Content standards can evolve to take advantage of more
modern technology

© CDISC 2014
 Dataset-XML Use Case Example
• Case 2: Dataset-XML for operational uses
Sponsor Regulatory Agency

Review Tools Analysis Programs Review Tools Analysis Programs

Dataset Dataset
-XML -XML

Define- Define-
XML XML

Archive Archive

© CDISC 2012 157

 ODM Data
SubjectData

attributes
Audit

Signature @ SubjectKey

InvestigatorRef @ TransactionType

SiteRef Audit
Annotation Signature

Annotation
StudyEventData Audit

FormData Signature

ArchiveLayoutRef

Annotation Audit

Signature
ItemGroupData Annotation

ItemData

158
© CDISC 2011
Dataset-XML Capabilitities
• Typed data
 Automated content validation

• Audit Trails, Signatures and Annotations

© CDISC 2011
Supports only ‘untyped’ data (so far)

© CDISC 2012
Exercise 6
Explore Dataset-XML examples.

1. Click on Exercise 6 tab in Exercise Workbook.

2. Follow steps

Use files in Exercises/Dataset-XML Examples:

Untyped_Data_Example-adam
Untyped_Data_Example-sdtm

© CDISC 2012
 Topics

Introduction to Define-XML
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

162
Analysis Results Metadata
• Standard for describing key Analysis Results using
XML
 Separate “extension” to Define-XML
 Adds information to ADaM Define-XML
 Final version of standard published in January2015
• Provides traceability from analysis results back to
ADaM data used to generate analysis
 Analysis methods used
 Reason analysis was performed
 Data selection criteria

• Available for download at http://www.cdisc.org/adam

© CDISC 2012
Role of Analysis Results Metadata
• Facilitates review by documenting relationship
between analysis results and the analysis
datasets.
• Recommended in PMDA Technical Conformance
Guide
 For key efficacy and safety results
 Clinical study results that provide rationale for setting
dose and administration

© CDISC 2012
Components of Analysis Results
Metadata
• Analysis Display metadata definitions
 Analysis Result metadata definitions
• Analysis Parameters
• Analysis dataset(s)
– Analysis variable(s)
– Selection criteria
• Documentation
• Programming Statements

© CDISC 2012
List of Displays

Display Details

© CDISC 2012
 Structure of Define-XML Metadata

MetaDataVersion

def:SupplementalDoc

def:ValueListDef

def:WhereClauseDef

ItemGroupDef

ItemDef

CodeList

MethodDef

def:CommentDef

def:leaf

arm:AnalysisResultDisplays

© CDISC 2012
 Structure of Define-XML Metadata
arm:AnalysisResultDisplays
MetaDataVersion

arm:ResultDisplay
def:SupplementalDoc

def:ValueListDef Description

def:WhereClauseDef
def:DocumentRef
ItemGroupDef arm:AnalysisResult
ItemDef
Description
CodeList
arm:AnalysisDatasets
MethodDef

def:CommentDef def:WhereClauseRef

def:leaf arm:AnalysisVariable

arm:AnalysisResultDisplays arm:Documentation

arm:ProgrammingCode

arm:Code

© CDISC 2012
 2
1

<arm:AnalysisResultDisplays> 1
<arm:ResultDisplay OID="RD.Table_14-3.01" Name="Table 14-3.01">
<Description><TranslatedText xml:lang="en">
2
Primary Endpoint Analysis: ADAS-Cog - Summary at Week 24 - LOCF (Efficacy Population)
</TranslatedText> </Description>
<def:DocumentRef leafID="LF.Table-14-3.01">
<def:PDFPageRef PageRefs="2" Type="PhysicalRef"/>
</def:DocumentRef>
<arm:AnalysisResult OID="AR.Table_14-3.01.R.1" ParameterOID="IT.ADQSADAS.PARAMCD"
AnalysisReason="SPECIFIED IN SAP“AnalysisPurpose="PRIMARY OUTCOME MEASURE">
<Description><TranslatedText xml:lang="en">
3 Dose response analysis for ADAS-Cog changes from baseline
</TranslatedText></Description>
.
.
.
1

<arm:AnalysisResult
OID="AR.Table_14-3.01.R.1"
1 ParameterOID="IT.ADQSADAS.PARAMCD"

AnalysisReason="SPECIFIED IN SAP"
AnalysisPurpose="PRIMARY OUTCOME MEASURE">
<Description>
<TranslatedText xml:lang="en">Dose response analysis for ADAS-Cog changes from
baseline</TranslatedText>
</Description>
<arm:AnalysisDatasets>
<arm:AnalysisDataset ItemGroupOID="IG.ADQSADAS" >
1
<def:WhereClauseRef WhereClauseOID="WC.Table_14-3.01.R.1.ADQSADAS" />
<arm:AnalysisVariable ItemOID="IT.ADQSADAS.CHG"/>
</arm:AnalysisDataset>
<def:WhereClauseDef 1
OID="WC.Table_14-3.01.R.1.ADQSADAS">
</arm:AnalysisDatasets>
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.PARAMCD">
1
<CheckValue>ACTOT</CheckValue>
</RangeCheck>
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.AVISIT">
<CheckValue>Week 24</CheckValue>
</RangeCheck>
2

<arm:AnalysisResult
OID="AR.Table_14-3.01.R.1"
ParameterOID="IT.ADQSADAS.PARAMCD"
AnalysisReason="SPECIFIED IN SAP"
AnalysisPurpose="PRIMARY OUTCOME MEASURE">
<Description>
<TranslatedText xml:lang="en">Dose response analysis for ADAS-Cog changes from
baseline</TranslatedText>
</Description>
<arm:AnalysisDatasets>
<arm:AnalysisDataset ItemGroupOID="IG.ADQSADAS" >
<def:WhereClauseRef WhereClauseOID="WC.Table_14-3.01.R.1.ADQSADAS" />
2
<arm:AnalysisVariable ItemOID="IT.ADQSADAS.CHG"/>
2
</arm:AnalysisDataset>
<ItemDef OID="IT.ADQSADAS.CHG" Name="CHG" SASFieldName="CHG" DataType="integer" Length=
</arm:AnalysisDatasets>
<Description> 2
<TranslatedText xml:lang="en">Change from Baseline</TranslatedText>
</Description>
<def:Origin Type="Derived"/>
</ItemDef>
 3

<arm:AnalysisResult OID="AR.Table_14-3.01.R.1"
ParameterOID="IT.ADQSADAS.PARAMCD"
AnalysisReason="SPECIFIED IN SAP" 3
4 AnalysisPurpose="PRIMARY OUTCOME MEASURE">
<Description>
<TranslatedText xml:lang="en">Dose response analysis for ADAS-Cog changes from
baseline</TranslatedText>
</Description>
<arm:AnalysisDatasets>
<arm:AnalysisDataset ItemGroupOID="IG.ADQSADAS" >
<def:WhereClauseRef WhereClauseOID="WC.Table_14-3.01.R.1.ADQSADAS" />
<arm:AnalysisVariable ItemOID="IT.ADQSADAS.CHG"/>
</arm:AnalysisDataset>
</arm:AnalysisDatasets>
5
6

<arm:AnalysisResult
OID="AR.Table_14-3.01.R.1"
ParameterOID="IT.ADQSADAS.PARAMCD"
<def:WhereClauseDef OID="WC.Table_14-3.01.R.1.ADQSADAS"> 6
AnalysisReason="SPECIFIED IN SAP"
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.PARAMCD">
AnalysisPurpose="PRIMARY OUTCOME MEASURE"> <ItemGroupDef OID="IG.ADQSADAS"
<CheckValue>ACTOT</CheckValue>
<Description> Name="ADQSADAS"
</RangeCheck>
<TranslatedText xml:lang="en">Dose response analysis for ADAS-Cog changes from
SASDatasetName="ADQSADAS"
<RangeCheck Comparator="EQ" SoftHard="Soft" 5 def:ItemOID="IT.ADQSADAS.AVISIT">
baseline</TranslatedText> Repeating="Yes"
<CheckValue>Week 24</CheckValue>
</Description> IsReferenceData="No"
</RangeCheck>
<arm:AnalysisDatasets> 5
Purpose="Analysis"
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.EFFFL">
<arm:AnalysisDataset ItemGroupOID="IG.ADQSADAS" >
def:Structure="One record per subject per param
<CheckValue>Y</CheckValue>
6 <def:WhereClauseRef WhereClauseOID="WC.Table_14-3.01.R.1.ADQSADAS" />
</RangeCheck> def:Class="BASIC DATA STRUCTURE"
<arm:AnalysisVariable ItemOID="IT.ADQSADAS.CHG"/>
def:CommentOID="COM.ADQSADAS"
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADQSADAS.ANL01FL">
</arm:AnalysisDataset> def:ArchiveLocationID="LF.ADQSADAS">
<CheckValue>Y</CheckValue>
</arm:AnalysisDatasets> …
</RangeCheck>
</def:WhereClauseDef>
 7

<arm:AnalysisResult OID="AR.Table_14-3.01.R.1" ParameterOID="IT.ADQSADAS.PARAMCD“

AnalysisReason="SPECIFIED IN SAP" AnalysisPurpose="PRIMARY OUTCOME MEASURE">
<Description> [2 lines]
<arm:AnalysisDatasets> [5 lines]
<arm:Documentation>
7 <Description>
<TranslatedText xml:lang="en">Linear model analysis of CHG for dose response; using randomized
dose (0 for placebo; 54 for low dose; 81 for high dose) and site group in model. Used PROC GLM in SAS to
produce p-value (from Type III SS for treatment dose).
</TranslatedText>
</Description>
7 <def:DocumentRef leafID="LF.SAP-SEC-10.1.1">

<def:PDFPageRef PageRefs="4" Type="PhysicalRef"/>

 <arm:AnalysisResult OID="AR.Table_14-3.01.R.1" ParameterOID="IT.ADQSADAS.PARAM
AnalysisReason="SPECIFIED IN SAP" AnalysisPurpose="PRIMARY OUTCOME M
<Description> [2 lines]
<arm:AnalysisDatasets> [5 lines]
<arm:Documentation> [8 lines]
8 <arm:ProgrammingCode Context="SAS version 9.2">
<arm:Code>
proc glm data = ADQSADAS;
where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ACTOT";
class SITEGR1;
model CHG = TRTPN SITEGR1;
run;
</arm:Code>
</arm:ProgrammingCode>
</arm:AnalysisResult>

8
 Topics

Introduction to Define-XML
Define-XML
XML essentials

Metadata representation

Dataset-XML

Analysis Results Metadata

Building Define-XML files

178
Building Define-XML
• Tools
• Stylesheets
• Testing & Validation

© CDISC 2012
Tooling Options
• Define-XML Creation
 Commercial applications
• SAS Clinical Standards Toolkit
• Pinnacle21 Community Version
• Formedix
• Xclinical Tabulator
• XML4Pharma SDTM-ETL
 Toolkits provided by consultants
 CROs
• Validation tools
 Pinnacle21
 Define.xml Checker (XML4Pharma)

© CDISC 2012
Stylesheet Challenges
• Defining display requirements
 Goal is to help reviewers understand data contents
• Platform dependencies
 Browsers
• Link navigation
• Printing

© CDISC 2012
© CDISC 2012
A note about XSL
• XSL is a programming language that is extremely
useful for transforming the information in an XML
file into a readable display
• XSL generated displays are key for reviewers.

 Generating a Define-XML that displays correctly requires

careful attention to generating the content of the Define-
XML file.

 Some invalid Define-XML files may still display correctly

– so you need to check the validity in addition.

© CDISC 2012
 Define.XML Validation
Define-XML conformity is define by
• XML Syntactic & Semantic requirements defined by the
Define-XML schema
• Define-XML Semantic requirements & Business rules
defined by the Define-XML 2.0 Specification

ValidationTools
• Validating parsers
• Pinnacle 21

Resources
• Whitepaper www.cdisc.org/define-xml
184
© CDISC 2012
Define-XML Conformity
Compliant with normative content in Define-XML
specification

&
Validates to Define-XML Schema

185
© CDISC 2012
External File References

© CDISC 2012
 Annotated CRF

4
<def:leaf ID="LF.acrf" xlink:href=“aCRF.pdf">
<def:title>Annotated Case Report Form</def:title>
</def:leaf>

© CDISC 2012
 Reviewers’ Guide (SDTM)

<def:SupplementalDoc>
<def:DocumentRef leafID="LF.ReviewersGuide"/>
<def:DocumentRef leafID="LF.ComplexAlgorithms"/>
</def:SupplementalDoc>

<def:leaf ID="LF.ReviewersGuide" xlink:href="reviewersguide.pdf">

2 <def:title>Reviewers Guide</def:title>

</def:leaf>

© CDISC 2012
 Dataset References

<ItemGroupDef OID="IG.ADSL" Name="ADSL" SASDatasetName="ADSL" Repeating="No"

IsReferenceData="No" Purpose="Analysis" def:Structure="one record per subject"
def:Class="SUBJECT LEVEL ANALYSIS DATASET" def:CommentOID="COM.ADSL"
1 def:ArchiveLocationID="LF.ADSL">
<Description>
<TranslatedText xml:lang="en">Subject-Level Analysis</TranslatedText>
</Description>
<ItemRef ItemOID="IT.ADSL.STUDYID" OrderNumber="1" Mandatory="No"/>
…
<ItemRef ItemOID="IT.ADSL.MMSETOT" OrderNumber="48" Mandatory="No"
MethodOID="MT.ADSL.MMSETOT"/>
1 <def:leaf ID="LF.ADSL" xlink:href="adsl.xpt">
<def:title>adsl.xpt </def:title>
1
</def:leaf>
</ItemGroupDef>
© CDISC 2012
 eCTD Specifications for Organizing
Submission Datasets
FDA Technical PMDA Technical
Conformance Guide Conformance Guide

© CDISC 2012 191

 XSL Stylesheet Reference
Note that the Define-XML example files
reference a Stylesheet in a sibling folder.

Both FDA and PMDA recommend placing the

Stylesheet in the folder with the datasets.

<?xml version="1.0" encoding="UTF-8"?>

<?xml-stylesheet type="text/xsl" href="../stylesheets/define2-0-0.xsl"?>
<ODM
xmlns="http://www.cdisc.org/ns/odm/v1.3"
xmlns:xlink="http://www.w3.org/1999/xlink"
xmlns:def="http://www.cdisc.org/ns/def/v2.0"
ODMVersion="1.3.2"
FileOID="www.cdisc.org.Studycdisc01-Define-XML_2.0.0"
FileType="Snapshot"
CreationDateTime="2013-03-03T17:04:44"
Originator="CDISC XML Technologies Team"
SourceSystem="MH-System"
SourceSystemVersion="2.0.1"
>

© CDISC 2012
OIDs
• OIDs are used throughout the Define-XML to
provide unique identifiers for elements.
• OID references are used to reference specific
element definitions.
 ItemOID
 CodelistOID
 MethodOID
 ValueListOID
 …
• The Define-XML sample files use a naming
convention designed to make examples easier to
read. This naming convention is not part of the
standard.
• OIDs must be machine generated.
© CDISC 2012
Building Define-XML Q&A

© CDISC 2012
Thank You!
Merci!
Danke!
Dankie
Grazie!
Gracias!

Sally.Cassells@gmail.com

195
© CDISC 2012
Thank you for attending.
Please complete the feedback survey that will be
sent to your inbox within the next couple of days.
PDF certificates of attendance will shortly follow.

Learn CDISC from CDISC!

Authoritative. Global. Vendor-neutral.
training@cdisc.org

© CDISC 2012
CDISC Membership Benefits
• Gold Membership
 Access to Member’s Only area of website
 Access to Members Only Webinars
 20% off all CDISC-hosted conferences and education
events
 Opportunity to obtain CDISC ODM Certification
 Opportunity to obtain CDISC Registered Solution
Provider
 Opportunity to participate in CDISC licensed course
program
 Personalized company plaque

© CDISC 2012
Membership Benefits Cont’d
• Platinum Membership
 All Gold Membership benefits
 40% (already includes 20% discount for Gold
Membership) discount on CDISC-hosted events and
Education courses
 Representation on CDISC Advisory Council
• Networking opportunities with clients, visionaries, and other peers
• Opportunity for Board Committee Representation (Financial,
Strategy, Technical)
• Voting privileges for Board of Directors
• Participation in town hall meetings with regulators and CDISC
Board Members
• Free one-time access to F2F training of Global Approach to
Accelerating Medical Research course

© CDISC 2012
Contact Information and Helpful Links
• For membership inquiries, please contact
membership@cdisc.org
• For education inquiries, please contact
training@cdisc.org
• For general CDISC inquiries, please contact
info@cdisc.org

• Click here for more info on CDISC Education

• Click here for more info on CDISC Membership

© CDISC 2012 199

Extra Slides/Resources for trainers

© CDISC 2012
Exercise Materials
• Define-XML Examples folder
• Dataset-XML Examples folder
• ExerciseWorkbook.xslx – Step by step instructions
• SDTM-Metadata-Worksheet.xlsx – Excel
workbook generated using Open CDISC (V2.0.2)
• ADaM-Worksheet-Worksheet.xslx – Excel
workbook generated using Open CDISC (V2.0.2)
• ExerciseOutput folder
 Define-XML displays with ‘answers’ to exercises 3 & 5
 Excel files for Exercises 3,4,5

© CDISC 2014
 Exercises
Exercise 1 - Locate sample files then open and browse

Exercise 2 – Origin Metadata

Exercise 3 – CodelistMetadata

Exercise 4 – Comments and external documents

Exercise 5 – Value level metadata

Exercise 6 -- Dataset-XML

Discussion -- Building Define-XML Files (pass out Index

cards at beginning or at lunch)

202
 Timing
8:30-10:45 - Introduction, XML essentials, Datasets and
variables, Exercise 1

10:45-11:18 – Origin, Exercise 2

11:18-11:30 – Codelists, Exercise 3

11:30 -noon – Comments, Exercise 4

1:00 – 2:00 Value level metadata – Exercise 5

2:00 – 2:30 Dataset-XML – Exercise 6

2:30 – 3:00 Analysis Results Metadata

3:00 – 4:30 Building Define-XML Files – Discussion

203
 Timing (Osaka)
9:00-10:45 - Introduction, XML essentials, Datasets and variables, Exercise
1 (including short break)

10:45-11:15 – Origin, Exercise 2

11:15-11:30 – Codelists, part 1

Lunch 11:30-13:00

13:00-13:50 – Codelist part 2 + Exercise 3

13:50 -14:20 -– Comments, Exercise 4 (10’ break)

14:30 – 15:30 -- Value level metadata – Exercise 5

15:35 – 16:05 Dataset-XML (Exercise 6 “left to the reader”)

16:05 – 16:25 Analysis Results Metadata

16:25 – 17:00 Building Define-XML Files – Q&A

204