The CDISC Foundational Standards are the basis of the complete suite of harmonized CDISC standards, designed to enhance the quality, efficiency and cost effectiveness of clinical research processes from beginning to end.

Study Data Tabulation Model (SDTM) v1.6 and Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.1 Release

CDISC is pleased to announce the release of SDTM v1.6 and SENDIG-DART v1.1. SDTM v1.6 supports SENDIG-DART v1.1 and includes additional variables related to DART animal studies. 

SDTM 1.6 -  HTML Format

SDTM v1.6 is the second standard to be published in HTML format. HTML format expedites delivery of the standard to implementers and is viewable in any standard browser. It allows users to search for keywords within the page, and bookmark the information in a browser. 

SENDIG-DART v1.1

SENDIG-DART v1.1 is now a final publication and supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and 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 v1.0 focuses on EFD, other study designs will be covered in future releases.

SDTM v1.7 Public Review Ended

The public review periord for SDTM v1.7 ended 13 NOV. SDTM v1.7 supports SDTM Implementation Guide (IG) v3.3 and SDTMIG-Medical Devices (MD) v1.1. We estimate to publish SDTM v1.7 in Q1 2018.

Japanese SDTM IG v3.2 Public Review

The Nagoya Medical Center, Translational Research Informatics Center (TRI) and CDISC Japan User Group (CJUG) SDTM Team have worked collaboratively to translate the Study Data Tabulation Model Implementation Guide version 3.2 (SDTMIG v3.2) into Japanese.

Public review of SDTMIG v3.2 is solely to assess the quality of the translation of SDTMIG v3.2 into Japanese and is being carried out in small batches rather than for the whole document at once, while taking into consideration the document as a whole. Public review for the first batch was completed 20 OCT; public review for the second batch was completed 24 Nov. Public review for the third batch is currently underway. CDISC and the J3C encourage those using this standard in Japan to participate in this public review in order to contribute to the improvement and quality of the translation.