The CDISC SEND Team is pleased to announce the release of the SEND Implementation Guide (IG) Version 3.0.
The SENDIG 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 now the 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).
For More Information Click here: CDISC Nonclinical Data
No comments:
Post a Comment