CDISC’s Requirements About SEND

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CDISC’s Requirements About SEND

SEND (Standard for Exchange of Nonclinical Data, Non-Clinical Data Interchange Standards Consortium）Clinical Data Interchange Standards Consortium (Clinical Data Interchange Standards Consortium) Numerical formalism.

On September 15th of this year, the FDA CDER issued an enforcement request IND and an NDA/BLA application, supporting the submission of a non-payment test SEND number (Dataset). The Dataset code for the data set is to be confirmed and sent by the FDA SEND formal communication request.

 

Mr. Harahara, Director of FDA standardization research. Origin: FDA

When did it Start to Operate the SEND Dataset?

FDA CDER general request IND on September 15, 2021, support NDA/BLA China-China demand negotiations, non-table trial SEND Dataset, including comprehensive GLP and non-GLP trial. If the SEND Dataset cannot be passed, the FDA approval has been rejected.

 

SENDIG is a reference-specific SDTM model. However, SDTM is a comprehensive model of the original capital. In this case, this small model is compatible with both directions. SENDIG supports multiple-dose general toxicology, multiple-dose general toxicology, carcinogenicity research, and safety science research.

Support for other research categories than SENDIG. For example, SENDIG-DART v1.2 has been established, and DART research collection includes certain specific numerical recommendations, especially embryo-fetal development (EFD) research, and juvenile animal behavioral toxicity research. SENDIG-AR v1.0 Supports the basic infrastructure and ongoing research. In addition to the model implementation guidelines, we will develop the consistency guideline, so you can be sure of the generative number structure combination.

Under what circumstances will FDA refuse to accept a submitted SEND Dataset?

If the submitted SEND Dataset has the following problems, FDA will refuse to accept it:

  • Missing corresponding ts.xpt Dataset
  • Incorrectly filling in the STF file tag of Dataset
  • Missing DM Dataset and define.xml
  • Missing STF files

Reference:

[1]. CDISC Website: SEND. https://www.cdisc.org/standards/foundational/send