CDISC Protocol Representation Model (CDISC-PRM) Standard

A CDISC Protocol Representation Model (CDISC-PRM) Standard is a CDISC foundational standard for planning and designing a research protocol.

• Context:
  • It can be available at: https://cdisc.org/standards/foundational/protocol.
  • It can be in alignment with eligibility criteria and requirements of ClinicalTrials.gov, World Health Organization (WHO), and EudraCT registries.
  • …
• Example(s):
  • Protocol Toolset v1.0 (~2012-04-20).
  • PRM v1.0 (~2010-01-30).
  • …
• Counter-Example(s):
  • CDISC-ADaM,
  • CDISC-CDASH,
  • CDISC-SDTM,
  • CDISC-SEND.
  • CDISC-ODM.
• See: CDISC Semantics Standard, CDISC Therapeutic Area (TA) Standard, Clinical Data Interchange Standards Consortium (CDISC) RWD Connect Initiative, Standard-Developing Organization, Clinical Trial Data, Clinical Data Standards, CDISC BRIDG Model. CDISC SHARE Application Programming Interface (API), CDISC SHARE Software Ecosystem.

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References

2022a

• (CDISC, 2022) ⇒ https://www.cdisc.org/standards/foundational/protocol Retrieved:2022-2-27.
  • QUOTE: Protocol Representatation 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.

2022b

• (CDISC, 2022) ⇒ https://www.cdisc.org/standards/foundational Retrieved:2022-2-25.
  • QUOTE: CDISC Foundational Standards are the basis of a complete suite of data standards, enhancing the quality, efficiency and cost effectiveness of clinical research processes from beginning to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.
  • 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.
  • Standard for Exchange of Nonclinical Data (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.
  • (...)

2022c

• (Facile et al., 2022) ⇒ Rhonda Facile, Erin Elizabeth Muhlbradt, Mengchun Gong, Qingna Li, Vaishali Popat, Frank Petavy, Ronald Cornet, Yaoping Ruan, Daisuke Koide, Toshiki I. Saito, Sam Hume, Frank Rockhold, Wenjun Bao, Sue Dubman, Barbara Jauregui Wurst (2022). "Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey". In: JMIR medical informatics, 10(1), e30363.
  • QUOTE: The CDISC standards span the clinical research process and include standards for the exchange of nonclinical data (SEND), data collection case report forms (CRFs; clinical data acquisition standards harmonization (CDASH)), aggregation and tabulation (study data tabulation model (SDTM)), Biomedical Research Integrated Domain Group (BRIDG) logical model, and operational data model (ODM) for transport (Figure 1). In collaboration with the National Cancer Institute's Enterprise Vocabulary Services (NCI-EVS) program, CDISC has developed a rich controlled terminology that is linked to other common research semantics through the NCI-EVS tools. These standards, presented in data models, implementation guides, and user guides, are globally recognized and heavily used by the biopharmaceutical industry and some academic institutions.

Figure 1: Clinical Data Interchange Standards Consortium standards in the clinical research process. ADaM: Analysis Data Model; BRIDG: Biomedical Research Integrated Domain Group; CDASH: clinical data acquisition standards harmonization; ODM: operational data model; PRM: Protocol Representation Model; SDM: Study Design Model; SDTM: study data tabulation model.

2018

• (Hume et al., 2018) ⇒ Samuel Hume, Anthony Chow, Julie Evans, Frederik Malfait, Julie Chason, J. Darcy Wold, Wayne Kubick,and Lauren B. Becnel (2018). "CDISC SHARE, a Global, Cloud-based Resource of Machine-Readable CDISC Standards for Clinical and Translational Research". In: AMIA Summits on Translational Science Proceedings, 2018, 94.
  • QUOTE: CDISC standards (Figure 1) are categorized as Foundational Standards, Semantics, Therapeutic Area (TA) Standards, and Transport Standards. Foundational Standards include Standard for Exchange of Nonclinical Data (SEND) for the collection and tabulation of animal model and other pre-clinical data, Protocol Representation Model (PRM), Analysis Data Model (ADaM) for defining analysis datasets, Clinical Data Acquisition Standards Harmonization (CDASH) that provide a minimal set of data elements common to essentially all studies, the Study Data Tabulation Model (SDTM) for data tabulation, and others.

Figure 1: CDISC End-to-end Standards including Foundational Standards, Semantics, and TA Standards.

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