Standard for Exchange of Nonclinical Data (SEND)

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A Standard for Exchange of Nonclinical Data (SEND) is a CDISC Foundational Standard that is an implementation of the SDTM standard for nonclinical studies.



References

2022a

A Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) is developed in reference to a specific SDTM model. However, the SDTM is cumulative – each new release builds on the previous model. Therefore, the models are backward compatible. The SENDIG is designed to support data typically found in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies, as well as respiratory and cardiovascular testing conducted during safety pharmacology studies.

2022b

  1. Required by the FDA (U.S.) for new drug applications
  2. 2.0 2.1 2.2 Required by the FDA and PMDA (Japan) for new drug applications.

2022c

2022d

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.

2016

2016 CDISK-FS Fig1.jpg
Figure 1: ODM-based standards supporting the CDISC foundational standards content.