The CDISC SEND Implementation Guide (IG) Version 3.0 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 the US Food and Drug Administration (FDA). Version 3.0 of the SENDIG in the current production version and is designed to support single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. The SENDIG is based upon and should be used in close concert with Version 1.2 of the CDISC Study Tabulation Model (SDTM).
(Note: Need to review and test these links. The statement below needs to be adjusted and standardized – probably should be added to bottom of all standards pages after that)
The CDISC SEND Team is always interested in your comments or questions. Any feedback regarding SEND can be submitted to the CDISC SEND Team via email address: firstname.lastname@example.org or through the CDISC Discussion form.