CDISC Analysis Data Model

Abbreviation: CDISC ADaM

General Information

ADaM defines dataset and metadata standards that support the efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).

Homepage https://www.cdisc.org/standards/foundational/adam

Countries that developed this resource United States

Taxonomic range

Homo sapiens

Knowledge Domains

Subjects

How to cite this record FAIRsharing.org: CDISC ADaM; CDISC Analysis Data Model; DOI: https://doi.org/10.25504/FAIRsharing.dvxkzb; Last edited: April 27, 2021, 8:04 a.m.; Last accessed: Jun 15 2021 4:06 a.m.

This record is maintained by awhite

Record updated: April 16, 2021, 5:50 p.m. by The FAIRsharing Team.

Show edit history

Edits to 'https://fairsharing.org/FAIRsharing.dvxkzb' by 'The FAIRsharing Team' at 17:50, 16 Apr 2021 (approved):

	'organizations' has been modified:
		Before:
			CDISC, Austin, TX, USA|https://www.cdisc.org/|Maintains
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov|Undefined
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmda.go.jp/english/|Undefined
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Maintains
		After:
			CDISC, Austin, TX, USA|https://www.cdisc.org/|Maintains
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov|Undefined
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmda.go.jp/english/|Undefined
		Added:
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
		Removed:
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Maintains

Edits to 'https://fairsharing.org/FAIRsharing.dvxkzb' by 'The FAIRsharing Team' at 17:42, 16 Apr 2021 (approved):

	'organizations' has been modified:
		Before:
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov|Undefined
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmda.go.jp/english/|Undefined
			CDISC, Austin, TX, USA|https://www.cdisc.org/|Maintains
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
		After:
			CDISC, Austin, TX, USA|https://www.cdisc.org/|Maintains
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov|Undefined
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmda.go.jp/english/|Undefined
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Maintains
		Added:
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Maintains
		Removed:
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined

Edits to 'https://fairsharing.org/FAIRsharing.dvxkzb' by 'awhite' at 19:13, 21 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
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmda.go.jp/english/|Undefined
		After:
			US Food and Drug Administration|http://www.fda.gov|Undefined
			Pharmaceuticals and Medical Device Agency (Japan)|https://www.pmda.go.jp/english/|Undefined
			CDISC|https://www.cdisc.org/|Maintains
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
		Added:
			US Food and Drug Administration|http://www.fda.gov|Undefined
			Pharmaceuticals and Medical Device Agency (Japan)|https://www.pmda.go.jp/english/|Undefined
			CDISC|https://www.cdisc.org/|Maintains
			Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined
		Removed:
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/|Funds
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmda.go.jp/english/|Undefined

	'supportLinks' has been modified:
		Before:
			forum|http://www.cdisc.org/forums/analysis-data-model-adam
			online documentation|http://www.cdisc.org/adam-v2.1-%26-adamig-v1.0
			training|http://www.cdisc.org/adam-course
			training|https://www.cdisc.org/education/course/introduction-adam
		After:
			training|https://www.cdisc.org/education/course/adam-primer
			training|https://www.cdisc.org/education/course/adam-theory-and-application
		Added:
			training|https://www.cdisc.org/education/course/adam-primer
			training|https://www.cdisc.org/education/course/adam-theory-and-application
		Removed:
			forum|http://www.cdisc.org/forums/analysis-data-model-adam
			online documentation|http://www.cdisc.org/adam-v2.1-%26-adamig-v1.0
			training|http://www.cdisc.org/adam-course
			training|https://www.cdisc.org/education/course/introduction-adam

	'publications' has been modified:
		Before:
			A Cytel Case Study: The Use of CDISC Standards in Unilevers Cosmetics and Food Products Trials|Meghana Bhagwat|https://www.cdisc.org/system/files/all/article/application/pdf/cytel_unilever_cdisc_av_4final.pdf|
		After:
		Added:
		Removed:
			A Cytel Case Study: The Use of CDISC Standards in Unilevers Cosmetics and Food Products Trials|Meghana Bhagwat|https://www.cdisc.org/system/files/all/article/application/pdf/cytel_unilever_cdisc_av_4final.pdf|

Edits to 'https://fairsharing.org/FAIRsharing.dvxkzb' by 'awhite' at 16:18, 07 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, Austin, TX, USA|http://www.cdisc.org/|Maintains
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmrj.jp/eng/index_e.html|Undefined
		After:
			U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA|http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/|Funds
			Pharmaceuticals and Medical Device Agency, Japn|https://www.pmda.go.jp/english/|Undefined
		Added:
			Pharmaceuticals and Medical Device Agency, Japn|https://www.pmda.go.jp/english/|Undefined
		Removed:
			CDISC, Austin, TX, USA|http://www.cdisc.org/|Maintains
			Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo|https://www.pmrj.jp/eng/index_e.html|Undefined

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

	'homepage' has been modified:
		Before: http://www.cdisc.org/adam
		After: https://www.cdisc.org/standards/foundational/adam

	'description' has been modified:
		Before: The CDISC Analysis Data Model (ADaM) document specifies the fundamental principles and standards to follow in the creation of analysis datasets and associated metadata. ADaM supports efficient generation, replication, and review of analysis results.  ADaM provides a framework that enables analysis of the data, while at the same time allowing reviewers and other recipients of the data to have a clear understanding of the data's lineage from collection to analysis to results. Whereas ADaM is optimized to support data derivation and analysis, CDISC's Study Data Tabulation Model (SDTM) is optimized to support data tabulation.
		After: ADaM defines dataset and metadata standards that support the efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).?



	'publications' has been modified:
		Before:
			A Cytel Case Study: The Use of CDISC Standards in Unilevers Cosmetics and Food Products Trials|Meghana Bhagwat,  Ed by Andrea Vadakin|https://www.cdisc.org/system/files/all/article/application/pdf/cytel_unilever_cdisc_av_4final.pdf|
		After:
			A Cytel Case Study: The Use of CDISC Standards in Unilevers Cosmetics and Food Products Trials|Meghana Bhagwat|https://www.cdisc.org/system/files/all/article/application/pdf/cytel_unilever_cdisc_av_4final.pdf|
		Added:
			A Cytel Case Study: The Use of CDISC Standards in Unilevers Cosmetics and Food Products Trials|Meghana Bhagwat|https://www.cdisc.org/system/files/all/article/application/pdf/cytel_unilever_cdisc_av_4final.pdf|
		Removed:
			A Cytel Case Study: The Use of CDISC Standards in Unilevers Cosmetics and Food Products Trials|Meghana Bhagwat,  Ed by Andrea Vadakin|https://www.cdisc.org/system/files/all/article/application/pdf/cytel_unilever_cdisc_av_4final.pdf|

Edits to 'https://fairsharing.org/FAIRsharing.dvxkzb' by 'The FAIRsharing Team' at 09:42, 12 Jul 2018 (approved):

	'miriam_url' has been modified:
		Before: None
		After:

In Collections

eTRIKS Standards Starter Pack

CDISC

ISO/CD 20691 Collection - DRAFT

RDA Covid-19 WG Resources

Support

General

training	ADaM Primer
training	ADaM Theory and Application

Additional Information

Contact

Ann White

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This record is maintained by awhite

Maintains

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

Undefined

Innovative Medicines Initiative (IMI), Europe (Consortium)
U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA (Government body)
Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo (Government body)

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