Published Date:

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.

Errors that Affect Conformance