Developmental and Reproductive Toxicology Version 1.0 (Draft) Now Available for Public Review – Comments due 13 August 2015
The CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 draft supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on the SENDIG for single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. While this release (v1.0) focuses on EFD, other study designs will be covered in future releases.
Please access the document package and provide comments through the CDISC Public Comment Tracker tool.
You will need to login or register for a CDISC portal account to use the tool. Help is also available on the Public Comment Tracker page. Instructions on using the Public Comment Tool