CDISC Protocol Representation Model (CDISC-PRM) Standard

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



References

2022a

2022b

  1. Required by the FDA (U.S.) for new drug applications

2022c

2018

  1. Standard for Exchange of Nonclinical Data (SEND) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/send.
  2. CDISC. CDISC Protocol Representation Model Version 1.0. http://cdisc.org/ CDISC. 2010.
  3. Analysis Data Model (ADaM) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/adam
  4. Clinical Data Acquisition Standards Harmonization (CDASH) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/cdash.
  5. Study Data Tabulation Model (SDTM) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/sdtm.