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

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

Agenda 1. Define-XML introduction 2. Building Define-XML 3. Define-XML Validation

CDISC 数据标准模块 CDISC website www.cdisc.org

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.

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

SEND SDTM ADaM SEND SDTM ADaM Data Data Data Metadata Metadata Metadata Dataset- Define- XML XML ODM

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

Define-XML Structure MetaDataVersion Annotated case report forms def:AnnotatedCRF Reviewers guide def:SupplementalDoc Value level metadata def:ValueListDef Where clause definitions def:WhereClauseDef Datasets I temGroupDef Variable or value definitions I temDef Controlled terminology CodeList Computational algorithms MethodDef Comments def:CommentDef def:leaf Referenced documents

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

Define-XML 2.1 Specification

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

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

Before and After

1. Define-XML introduction 2. Building Define-XML 3. Define-XML Validation

• Define-XML Creation • Commercial applications • SAS Clinical Standards Toolkit • Pinnacle21 Community Version • Formedix • Xclinical Tabulator • XML4Pharma SDTM-ETL • CROs

Process Define-XML creation process P21 P21 SDTM/Adam Spec Excel Define Datasets Define-XML Spec Control Terminology macro macro aCRF Reviewers guide

Spec template

Excel Define-XML Spec Pinnacle 21 Spec template

Spec to Define-XML Pinnacle 21 Define-XML Generator

1. Define-XML introduction 2. Building Define-XML 3. 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 2.1 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

Pinnacle 21 Validator

Validation Results

Issue Details

Validation Rules

联系我们 咨询电话： 010-5944 2174 讲者：彭瑞玲 咨询邮箱： info@improve-quality.com 手机： 13426088975 邮箱： Ruiling.peng@improve-quality.com 公司网址： www.improve-quality.com 数据•标准 数据中心 数据•管理 隔天更新 数据•统计 追踪法规 数据•法规 分享知识 数据•软件 提高质量

Q & A