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. 

SEND is one of the required standards for data submission to FDA.

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.   


SENDIG-Animal Rule v1.0

1.0
Release Date: 17 Sep 2019

Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide: Animal Rule (SENDIG-AR) describes how to represent data for studies submitted under FDA regulations commonly known as the Animal Rule. The Animal Rule provides a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.

SENDIG-AR v1.0 is based upon, and should be used in close concert with, Version 1.8 of the Study Data Tabulation Model (SDTM) and Version 3.1 of the CDISC Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG). Although the SENDIG v3.1 is based on SDTM v1.5, any data submitted under the Animal Rule should follow the conventions used in this implementation guide, and be based on SDTM v1.8.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.


Confirmed Data Endpoints for Exchange (CoDEx) for SENDIG v3.1 Data

1.0
Release Date: 21 Aug 2019

Version 1.0 of the CoDEx for SENDIG v3.1 clarifies which study designs and study endpoints were intended to be standardized in the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) Version 3.1.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.


SENDIG-DART v1.1

1.1
Release Date: 11 Dec 2017

Version 1.1 of the SENDIG-DART (Developmental and Reproductive Toxicology) includes revisions to DART variables introduced in the provisional version as well as other revisions based on SDTM v1.6. To understand all changes, please see Appendix F Revision History. SENDIG-DART v1.1 supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on, and should be used in close concert with, SEND v 3.1 and SDTM v1.6. While SENDIG-DART v1.1 focuses on EFD toxicity, other study designs will be covered in future releases.

Metadata files, as well as a Diff file, which summarizes the changes from SENDIG-DART v1.0 to SENDIG-DART v1.1, including new, updated and deprecated/removed content, are available to CDISC Members from CDISC Library Archives. If you are an employee of a CDISC Member Organization, you can access this metadata by logging into your account and visiting the Members Only Area in the upper right-hand corner of the web site.

 

 


AttachmentSize
PDF icon SENDIG DART v1.11.27 MB

SENDIG v3.1

3.1
Release Date: 7 Jul 2016

SENDIG v3.1 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 v3.1 is based on, and should be used in close concert with, SDTM v1.5, which is included in the document package.

Significant changes since v3.0 include:

  • The variable VISITDY has been reclassified from Expected to Permissible, and three new variables were added to relevant domains (--USCHFL, --NOMLBL, --NOMDY). VISITDY will be phased out of the SENDIG over time. An explanation of these changes and how they will develop over time is in Section 4.4.
  • Two new domains for Safety Pharmacology studies have been added: Cardiovascular (CV) and Respiratory (RE); Vital Signs domain has been updated.
  • New FOCID variable added to several domains (EX, CL, MA, and MI). FOCID is available to all general observation classes to specify a study-specific point of interest.
  • Microscopic Findings domain updated, added three new variables (FOCID, --CHRON, --DISTR).
  • Updated ECG Test Results domain, added two new Timing variables (--STINT and –ENINT).

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process. 


AttachmentSize
Package icon SENDIG v 3.15.28 MB
File SENDIG v3.1 Public Review Comments45.94 KB

SENDIG v3.0

3.0
Release Date: 17 Jun 2011

Version 3.0 of SENDIG is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. Version 3.0 of the SENDIG is designed to support single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. The SENDIG is based on, and should be used in close concert with, SDTM v1.2.

For a better understanding of the study endpoints that can be confidently exchanged using the SENDIG v3.0, the SEND development team released a supplemental document, Confirmed Data Endpoints for SENDIG v3.0 Data Exchange (CoDEx 1.0 for SEND v3.0) on 16 Aug 2017

 


AttachmentSize
PDF icon SENDIG_v3.0.pdf1.9 MB
PDF icon CoDEx 1.0 for SENDIG v3.0127.18 KB