On August 21, 2017, a Federal Register Notice announced FDA's support for SEND v. 3.1 and the requirement start dates for NDAs (15 March 2019) and for INDs (15 March 2020). The FDA Data Standards Catalogue can be accessed from here. For a little more guidance on the implications, you can find some help for interpreting the Data Standards Catalogue here (open it as a pdf).
In the March 2017 version of the FDA Technical Conformance Guide, the PhUSE template for the nonclinical Study Data Reviewer Guide (nSDRG) is referenced. The nSDRG template, user guide and examples are available here.
The CDISC organization has announced the release of the Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 for provisional use. This version supports study data typically found in embryo-fetal developmental (EFD) toxicity studies. The SENDIG-DART is based on and should be used in accordance with the SENDIG v3.1 for single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. While this release (v1.0) focuses on EFD, other study designs will be covered in future releases.
The CDISC SEND Team is pleased to announce the SENDIG (Implementation Guide) v3.1 is now available (released 07 July 2016). The SENDIG is intended to guide the organization, structure, and format of standard non-clinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. The SENDIG is based on and should be used in close concert with CDISC Study Data Tabulation Model (SDTM) v1.5, which is included in the document package that can be downloaded here.
Note that the FDA adoption of SEND v. 3.1 is separate from the publication of the standard from CDISC. When they are ready, FDA will announce their support and requirements in the Data Standards Catalogue through a Federal Register Notice.
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For many years, Data Standards Decisions has been at the cutting edge of the evolving nonclinical data standards for the pharmaceutical industry. Providing data standardization consulting services across the pharmaceutical industry to help launch implementation projects and keep them within scope and on time. We know the ins and outs of the CDISC SEND model like no one else, and our knowledge can make the difference between a timely successful project and a long-term costly one.
Business Partner Services
We are pleased to be able to offer our clients training and support in
SENDIG v. 3.1 and SENDIG-DART v. 1.0
in addition to our services for SENDIG v. 3.0.
Special endpoints in general toxicology studies can be modeled in custom SDTM domains based on work in progress in the CDISC SEND team. Examples include morphometric measurements, behavioral assessments, test atmosphere characterization for inhalation studies.