Austin, TX – 23 March 2017 – The Clinical Data Interchange Standards Consortium (CDISC) and the Infectious Diseases Data Observatory (IDDO) announce the availability of a new standard to assist in the collection, aggregation and analysis of Ebola virus disease (EVD) research data. This standard is for use in EVD trials, leading to potential treatments and public health surveillance for this disease.
Austin, TX – 20 March 2017– The Clinical Data Interchange Standards Consortium (CDISC) today announced the addition of three new members to its Board of Directors. Mr. Dave Evans, Dr. Masanori Fukushima, and Mr. Steve Rosenberg have each begun serving a three-year term.
Austin, TX – 30 November 2016 – The Clinical Data Interchange Standards Consortium (CDISC) would like to remind the clinical research community that the FDA Binding Guidance goes into effect next month. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog. The current FDA Data Standards Catalog specifies the use of CDISC standards: SDTM, SEND, ADaM and Define-XML as well as Controlled Terminology.
Austin, TX – 14 November 2016 – The Clinical Data Interchange Standards Consortium (CDISC) announced today the open availability of a new clinical research data standard for Rheumatoid Arthritis (RA). The RA data standard and accompanying User Guide describe the most common biomedical concepts gathered from patient data relevant to clinical RA studies and defines concepts in a clear, unambiguous way, allowing researchers to effectively collect, manage, share and compare data to advance treatments and find breakthroughs.
TUCSON, Ariz., and AUSTIN, Texas – November 2, 2016 – The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path), and TransCelerate BioPharma, Inc. (TransCelerate), announce the open availability of a CDISC Therapeutic Area (TA) Standard for Kidney Transplantation. The Kidney Transplant v1.0 standard is focused on studies of therapeutic interventions to prevent rejection of transplanted kidneys in adult recipients.