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The SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.2 defines recommended standards for the submission of certain types of data collected in DART studies, in particular embryo-fetal development (EFD) studies and toxicity studies conducted on juvenile animals. The Implementation Guide is based on, and should be used in close concert with, SENDIG v3.1.1 and SDTM v1.6.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.