Edits to 'https://fairsharing.org/FAIRsharing.yr61md' by 'awhite' at 19:35, 21 Nov 2018 (approved):
'organizations' has been modified:
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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
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'supportLinks' has been modified:
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training|https://www.cdisc.org/education/course/define-xml
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training|https://www.cdisc.org/education/course/define-xml
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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
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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:
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forum|http://www.cdisc.org/forum
online documentation|http://www.cdisc.org/system/files/all/standard_category/application/pdf/crt_ddspecification1_0_0.pdf
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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
CDISC Define eXtensible Markup Language
