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 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