AUSTIN, TX – 15 January 2020 – CDISC today announced four new members have joined its Board of Directors: Dr. Wenjun Bao, Dr. Mihoko Okada, Dr. Erik Pulkstenis, and Dr. Christina Reith. Each began serving a three-year term at the beginning of the year. These members join current, sitting members, including David Evans and Steve Rosenberg, who will each be serving a second three-year term.
Austin, TX – 17 Dec 2019 – The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has released the requirements of clinical trial data submission in the electronic common technical document (eCTD) for public review in October. CDISC standards are now the preferred standards for electronic data submission in China. The new eCTD stipulates the use of SDTM, CDISC’s standard for formatting and organizing study data, and ADaM, CDISC’s standard for data analysis, for pharmaceutical sponsors submitting datasets in clinical trial databases and related materials. Going forward, CDISC standards are the only global data standard the CDE has recommended.
AUSTIN, TX – 10 Dec 2019 – CDISC is pleased to announce launch of the Korean CDISC Coordinating Committee (K3C) at the 2019 CDISC Korea Summit held 7 November in Daegu, South Korea. Dr. Maria Im Hee Shin of Daegu Catholic University Medical Center will serve as K3C Chair.
CDISC Coordinating Committees (3Cs) support global CDISC initiatives within specific regions of the world and provide regional feedback to the central CDISC organization. 3Cs represent CDISC around the globe and help strengthen relationships with international and local entities as well as organizations in their respective regions. Their primary aim is to promote the value of implementing CDISC standards to bring clarity to clinical research data.
Austin, TX – 18 Sep 2019 – CDISC is pleased to announce the first release of a global Therapeutic Area Standard using Traditional Chinese Medicine. Specifically, the standard describes how to use CDISC standards to represent data pertaining to coronary artery disease for the treatment of angina. Released in the form of a User Guide for data managers, statisticians, programmers and study managers, the standard is freely available on the CDISC website.
Austin, TX – 28 Aug 2019 – CDISC congratulates Bron Kisler, a founder of CDISC and long-time executive, on being elected Chair of the ISO/TC 215 Genomics Sub-Committee. Kisler was unanimously elected by 30 member countries from across Asia, Australia, Europe and the Americas. This newly launched Sub-Committee (SC) will standardize genomics data globally across ISO-member nations and beyond. The scope of the Genomics SC is “Standardization of computable data, information, and knowledge, including their representation and metadata, for the application of omics, including but not limited to genomics, transcriptomics and proteomics, to support human health and clinical research.”
MANHATTAN BEACH, CA and AUSTIN, TX – 27 Aug 2019 – The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, announced today a collaboration to establish the first-ever data standards specifically for pancreatic cancer.