CDISC Standard for Exchange of Nonclinical Data

Abbreviation: CDISC SEND

General Information

CDISC SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.

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

Countries that developed this resource United States

Taxonomic range

Knowledge Domains

Subjects

User-defined Tags

Non-clinical trial

How to cite this record FAIRsharing.org: CDISC SEND; CDISC Standard for Exchange of Nonclinical Data; DOI: https://doi.org/10.25504/FAIRsharing.7z842d; Last edited: Jan. 8, 2019, 1:37 p.m.; Last accessed: Jun 15 2021 5:22 a.m.

This record is maintained by awhite

Record updated: Nov. 27, 2018, 11:51 a.m. by The FAIRsharing Team.

Show edit history

Edits to 'https://fairsharing.org/FAIRsharing.7z842d' by 'The FAIRsharing Team' at 11:51, 27 Nov 2018 (approved):

	'description' has been modified:
		Before: SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format. 
		After: CDISC SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.

Edits to 'https://fairsharing.org/FAIRsharing.7z842d' by 'awhite' at 19:18, 21 Nov 2018 (approved):

	'organizations' has been modified:
		Before:
			CDISC|https://www.cdisc.org/|Maintains
		After:
			CDISC|https://www.cdisc.org/|Maintains
			US Food and Drug Administration|http://www.fda.gov|Undefined
			Pharmaceuticals and Medical Device Agency (Japan)|https://www.pmda.go.jp/english/|Undefined
			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
			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/send-implementation
		Added:
			training|https://www.cdisc.org/education/course/send-implementation
		Removed:

Edits to 'https://fairsharing.org/FAIRsharing.7z842d' by 'awhite' at 16:30, 08 Nov 2018 (approved):

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

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

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

	'description' has been modified:
		Before: The CDISC SEND standard is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to the US Food and Drug Administration (FDA).
		After: SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format. 

	'supportLinks' has been modified:
		Before:
			email|review@cdisc.org
			forum|http://www.cdisc.org/forum
			help|http://www.cdisc.org/stuff/contentmgr/files/0/333019e937e4a85fcfb8574ea9aa24d7/misc/sendigv3.zip
			training|http://www.cdisc.org/education
		After:
		Added:
		Removed:
			email|review@cdisc.org
			forum|http://www.cdisc.org/forum
			help|http://www.cdisc.org/stuff/contentmgr/files/0/333019e937e4a85fcfb8574ea9aa24d7/misc/sendigv3.zip
			training|http://www.cdisc.org/education

In Collections

eTRIKS Standards Starter Pack

CDISC

ISO/CD 20691 Collection - DRAFT

RDA Covid-19 WG Resources

Support

General

training

SEND Implementation

Additional Information

Contact

Ann White

Tools

No tools defined

Schemas

No XSD schemas defined

Access / Retrieve Data

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

United States Food and Drug Administration (FDA) (Government body)
Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo (Government body)
Innovative Medicines Initiative (IMI), Europe (Consortium)

CDISC Standard for Exchange of Nonclinical Data

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