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.