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CDISC Protocol Representation Model

Abbreviation: CDISC PRM

General Information

The CDISC Protocol Representation Model (PRM) provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.

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

Countries that developed this resource United States

Taxonomic range

Homo sapiens

Knowledge Domains

Subjects

How to cite this record FAIRsharing.org: CDISC PRM; CDISC Protocol Representation Model; DOI: https://doi.org/10.25504/FAIRsharing.grqm4q; Last edited: Jan. 8, 2019, 1:34 p.m.; Last accessed: Aug 02 2021 12:26 a.m.

This record is maintained by awhite

Record updated: Nov. 27, 2018, 11:46 a.m. by The FAIRsharing Team.

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Edits to 'https://fairsharing.org/FAIRsharing.grqm4q' by 'The FAIRsharing Team' at 11:46, 27 Nov 2018 (approved):

	'description' has been modified:
		Before: PRM provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.

		After: The CDISC Protocol Representation Model (PRM) provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.

Edits to 'https://fairsharing.org/FAIRsharing.grqm4q' by 'awhite' at 17:02, 07 Nov 2018 (approved):

	'supportLinks' has been modified:
		Before:
			blog|http://www.cdisc.org/cdisc-blog
			contact form|http://www.cdisc.org/contact
			training|https://cdiscprm-sandbox.imedidata.net/
		After:
		Added:
		Removed:
			blog|http://www.cdisc.org/cdisc-blog
			contact form|http://www.cdisc.org/contact
			training|https://cdiscprm-sandbox.imedidata.net/

	'description' has been modified:
		Before: The CDISC Protocol Representation Model Version 1.0 (PRM V1.0) is intended for those involved in the planning and design of a research protocol. The model focuses on the characteristics of a study and the definition and association of activities within the protocols, including arms and epochs.  PRM V1.0 also includes the definitions of the roles that participate in those activities. The scope of this model includes protocol content including Study Design, Eligibility Criteria, and the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries. The majority of business requirements were provided by subject matter experts in clinical trial protocols. PRM V1.0 is based on the BRIDG Release 3.0 Protocol Representation sub-domain.  It includes all classes in the BRIDG Protocol Representation sub-domain plus some classes from other BRIDG sub-domains, generally classes required for ClinicalTrials.gov and the WHO registries.
		After: PRM provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.


	'dataProcesses' has been modified:
		Before:
			download
		After:
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			download

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

	'miriam_id' has been modified:
		Before: None
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	'homepage' has been modified:
		Before: http://www.cdisc.org/protocol
		After: https://www.cdisc.org/standards/foundational/protocol

In Collections

eTRIKS Standards Starter Pack

CDISC

ISO/CD 20691 Collection - DRAFT

RDA Covid-19 WG Resources

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No support information provided.

Additional Information

Contact

Ann White

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This record is maintained by awhite

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

CDISC Protocol Representation Model

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