The CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 is now available (16 August 2016) for provisional use. This version supports study data typically found in embryo-fetal developmental (EFD) toxicity studies. The SENDIG-DART is based on and should be used in accordance with the SENDIG v3.1 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.
**Public Review Comments for SENDIG-DART v1.0**
SEND Implementation Guide v3.1
The CDISC SEND Team is pleased to announce the SENDIG (Implementation Guide) v3.1 is now available (released 07 July 2016). The SENDIG is intended to guide the organization, structure, and format of standard non-clinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. The SENDIG is based on and should be used in close concert with CDISC Study Data Tabulation Model (SDTM) v1.5, which is included in the document package.
Download the complete document package as a zip file.
** Public Review Comments for SENDIG v3.1 **
Some significant changes since v3.0 include:
- The variable VISITDY has been reclassified from Expected to Permissible, and three new variables were added to relevant domains (--USCHFL, --NOMLBL, --NOMDY). VISITDY will be phased out of the SENDIG over time. An explanation of these changes and how they will develop over time is in Section 4.4.
- Two new domains for Safety Pharmacology studies have been added: Cardiovascular (CV) and Respiratory (RE); Vital Signs domain has been updated.
- New FOCID variable added to several domains (EX, CL, MA, and MI). FOCID is available to all general observation classes to specify a study-specific point of interest.
- Microscopic Findings domain updated, added three new variables (FOCID, --CHRON, --DISTR).
- Updated ECG Test Results domain, added two new Timing variables (--STINT and –ENINT).
The CDISC SEND Implementation Guide (IG) Version 3.0 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 the current 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).
The CDISC SEND Team is always interested in your comments or questions. Any feedback regarding SEND can be submitted through the CDISC Discussion forum.