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.
Despite considerable potential benefits from using common standards for collecting and reporting information from clinical trials, research sponsors and investigators have been slow to move in this direction. That appears to be changing as the December 2016 deadline looms for meeting the FDA requirement that all applications for new drugs and biologics compile and submit clinical trial data electronically and according to standardized format.
CDISC conducted a series of Listening Tour teleconferences to hear from our member companies about the challenges and opportunities they face in implementing CDISC standards. This paper presents the results.
Austin, TX – 23 September 2016 – The Clinical Data Interchange Standards Consortium (CDISC) and Cohen Veterans Bioscience today announced a collaboration to establish a new CDISC Therapeutic Area Data Standard for post-traumatic stress disorder (PTSD).
Approximately 7 to 8 out of every 100 people will experience PTSD at some point during their lives and about 8 million adults have PTSD in a given year, according to the U.S. Department of Veterans Affairs National Center for PTSD.
Austin, TX – 20 September 2016 – The Clinical Data Interchange Standards Consortium (CDISC) announced today that Dr. Robert Califf, FDA Commissioner, will give the opening keynote at the 2016 CDISC International Interchange at 8:00AM ET on 28 September in Bethesda, MD. Dr. Califf will expand upon the theme of the 02 August 2016 CDISC Strategy Session: “The Future of Medical Research and the Role of Standards: Forming Connections Towards Complementary Systems.”