Published Date:

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.