Define-XML Creation & Validation Anran Xie Agenda 1. - - PowerPoint PPT Presentation

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Define-XML Creation & Validation Anran Xie Agenda 1. - - PowerPoint PPT Presentation

Mar 26, 2023 245 likes •553 views

Define-XML Creation & Validation Anran Xie Agenda 1. Define-XML introduction 2. Building Define-XML 3. Define-XML Validation CDISC CDISC website www.cdisc.org Define-XML introduction CDISC

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满足递交标准的Define-XML Creation & Validation

Anran Xie

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Agenda

  • 1. Define-XML introduction
  • 2. Building Define-XML
  • 3. Define-XML Validation
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CDISC website www.cdisc.org

CDISC数据标准模块

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Define-XML introduction

  • 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 & PMDA for all CDISC

submissions.

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Features

  • Platform independent
  • Vendor neutral
  • Open source
  • Machine readable
  • Easily transformed using XSL and other tools
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ODM

Define- XML

SEND Metadata SDTM Metadata ADaM Metadata

Dataset- XML

SEND Data SDTM Data ADaM Data

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ODM Structure

ODM Study AdminData ClinicalData ReferenceData MetaDataVersion I nclude Protocol StudyEventDef FormDef I temGroupDef I temDef CodeList Presentation MethodDef ConditionDef

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Define-XML Structure

MetaDataVersion

def:AnnotatedCRF def:SupplementalDoc def:ValueListDef def:WhereClauseDef I temGroupDef I temDef CodeList MethodDef def:CommentDef def:leaf

Annotated case report forms Reviewers guide Value level metadata Where clause definitions Datasets Variable or value definitions Controlled terminology Computational algorithms Comments Referenced documents

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Latest status

  • Current version: Define-XML 2.1
  • Released: 8 May 2019

URL: https://www.cdisc.org/standards/data-exchange/define-xml)

  • Specification
  • XML Schema
  • Stylesheets
  • Examples
  • ADaM
  • SDTM
  • Includes XSL stylesheet
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Define-XML 2.1 Specification

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XML Schema

  • 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
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XSL-Extensible Stylesheet Language

  • XSL is a sophisticated transformation language

with many built in functions

  • Requires a tool known as XSLT processor –

included in most browsers

  • For Define-XML we use XSL to display the XML

file as a web page

<?xml version="1.0"?> <xsl:stylesheet version="1.0“ ... XML Docum ent New Docum ent XSL Docum ent

XSLT

Processor

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Before and After

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  • 1. Define-XML introduction
  • 2. Building Define-XML
  • 3. Define-XML Validation
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  • Define-XML Creation
  • Commercial applications
  • SAS Clinical Standards Toolkit
  • Pinnacle21 Community Version
  • Formedix
  • Xclinical Tabulator
  • XML4Pharma SDTM-ETL
  • CROs
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Process

SDTM/Adam Spec Datasets Control Terminology Excel Define Spec Define-XML P21 P21 macro macro

Define-XML creation process

aCRF Reviewers guide

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Spec template

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Excel Define-XML Spec Pinnacle 21 Spec template

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Spec to Define-XML Pinnacle 21 Define-XML Generator

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  • 1. Define-XML introduction
  • 2. Building Define-XML
  • 3. Define-XML Validation
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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 2.1 Specification

ValidationTools

  • Validating parsers
  • Pinnacle 21

Validation rules

  • SD: SDTM3.2，454个
  • AD: ADaM 1.1, 342条
  • DD: define.xml 2.0, 136条
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Pinnacle 21 Validator

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Validation Results

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Issue Details

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Validation Rules

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联系我们

讲者：彭瑞玲 手机：13426088975 邮箱：Ruiling.peng@improve-quality.com

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Q & A