Published Date:
The SEND Implementation Guide: Genetic Toxicology (SENDIG-Genetox) v1.0 is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets including subject-level in vivo micronucleus data and comet data from in vivo genetic toxicology studies. These datasets are intended for exchange between organizations such as sponsors and contract research organizations, and for submission to regulatory authorities. SENDIG-Genetox is based upon, and should be used in close concert with, SDTM v1.5 and SENDIG v3.1.1.
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.