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CDISC Define eXtensible Markup Language

Abbreviation: CDISC Define-XML

General Information

Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC content standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.

Homepage https://www.cdisc.org/standards/data-exchange/define-xm

Countries that developed this resource United States

Taxonomic range

Homo sapiens

Subjects

How to cite this record FAIRsharing.org: CDISC Define-XML; CDISC Define eXtensible Markup Language; DOI: https://doi.org/10.25504/FAIRsharing.yr61md; Last edited: Jan. 8, 2019, 1:38 p.m.; Last accessed: Sep 20 2021 9:38 p.m.

This record is maintained by awhite

Record updated: Nov. 21, 2018, 7:35 p.m. by awhite.

Show edit history

Edits to 'https://fairsharing.org/FAIRsharing.yr61md' by 'awhite' at 19:35, 21 Nov 2018 (approved):

	'organizations' has been modified:
		Before:
		After:
			CDISC|https://www.cdisc.org/|Maintains
			Pharmaceuticals and Medical Devices Agency (Japan)|https://www.pmda.go.jp/english/|Undefined
			US Food and Drug Administration|http://www.fda.gov|Undefined
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
		Added:
			CDISC|https://www.cdisc.org/|Maintains
			Pharmaceuticals and Medical Devices Agency (Japan)|https://www.pmda.go.jp/english/|Undefined
			US Food and Drug Administration|http://www.fda.gov|Undefined
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
		Removed:

	'supportLinks' has been modified:
		Before:
		After:
			training|https://www.cdisc.org/education/course/define-xml
		Added:
			training|https://www.cdisc.org/education/course/define-xml
		Removed:

Edits to 'https://fairsharing.org/FAIRsharing.yr61md' by 'awhite' at 16:32, 08 Nov 2018 (approved):

	'organizations' has been modified:
		Before:
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/|Funds
			CDISC|https://www.cdisc.org|Maintains
		After:
		Added:
		Removed:
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/|Funds
			CDISC|https://www.cdisc.org|Maintains

	'supportLinks' has been modified:
		Before:
			forum|http://www.cdisc.org/forum
			online documentation|http://www.cdisc.org/system/files/all/standard_category/application/pdf/crt_ddspecification1_0_0.pdf
		After:
		Added:
		Removed:
			forum|http://www.cdisc.org/forum
			online documentation|http://www.cdisc.org/system/files/all/standard_category/application/pdf/crt_ddspecification1_0_0.pdf

	'description' has been modified:
		Before: This document specifies the standard for providing Case Report Tabulation Data Definitions in an XML format for submission to regulatory authorities (e.g., FDA). The XML schema used to define the expected structure for these XML files is based on an extension to the CDISC Operational Data Model (ODM).
		After: Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC content standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.

	'yearOfCreation' has been modified:
		Before: 2014
		After: None

	'contact' has been modified:
		Before: 
		After: Ann White

	'shortname' has been modified:
		Before: CDISC Define.xml
		After: CDISC Define-XML

	'homepage' has been modified:
		Before: http://www.cdisc.org/define-xml
		After: https://www.cdisc.org/standards/data-exchange/define-xm

Edits to 'https://fairsharing.org/FAIRsharing.yr61md' by 'The FAIRsharing Team' at 11:31, 15 Mar 2018 (approved):

	'year' has been modified:
		Before: None
		After: 2014

In Collections

eTRIKS Standards Starter Pack

CDISC

ISO/CD 20691 Collection - DRAFT

RDA Covid-19 WG Resources

Support

General

training

Define-XML

Additional Information

Contact

Ann White

Tools

No tools defined

Schemas

Name: CDISC-Define-XML
Version: 2.0

Download

	schema/cdisc-define-2.0/define-ns.xsd
	schema/cdisc-define-2.0/define2-0-0.xsd
	schema/cdisc-odm-1.3.2/xlink.xsd
	schema/cdisc-odm-1.3.2/ODM1-3-2-foundation.xsd
	schema/cdisc-odm-1.3.2/xml.xsd
	schema/cdisc-odm-1.3.2/xmldsig-core-schema.xsd
	schema/cdisc-odm-1.3.2/ODM1-3-2.xsd
	schema/cdisc-define-2.0/define-extension.xsd

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Conditions of Use

Publications

No publications available

Related Standards

Reporting Guidelines

No guidelines defined

Terminology Artifacts

Models and Formats

Identifier Schemas

No identifier schema standards defined

Metrics

No metrics standards defined

Related Databases (0)

No Related Databases

Implementing Policies

This record is not implemented by any policy.

Credit

Record Maintainer

This record is maintained by awhite

Maintains

CDISC, Austin, TX, USA (Charitable foundation) Lead

Undefined

Pharmaceuticals and Medical Devices Agency (Japan) (Government body)
United States Food and Drug Administration (FDA) (Government body)
Innovative Medicines Initiative (IMI), Europe (Consortium)

CDISC Define eXtensible Markup Language

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