Austin, TX – 05 May 2020 – CDISC has launched a project that will facilitate the use of electronic health record (EHR) data in clinical research to achieve efficiencies that expedite global regulatory reviews, contribute to the evaluation of new treatments for patients and drive next generation discovery.

Austin, TX – 22 April 2020 - CDISC has released an Interim User Guide, freely available on the CDISC website, which the research community can utilize to represent data in studies pertaining to COVID-19. The Interim User Guide provides examples and guidance on implementing CDISC standards for COVID-19 so that researchers can collect, structure and analyze data more effectively.

CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s spring virtual meetings. The broadcast is an opportunity for stakeholders to stay informed on what's going on with the development of SEND and its use in regulatory submissions.

01 April, 2020    9:00am – Noon EDT

Agenda

9:00am – 9:45am           OCS Visionary Presentation – Dr. Lilliam Rosario

Austin, TX – 27 MARCH 2020 - CDISC has launched a task force to rapidly develop guidance on standardizing COVID-19 research data with the participation of several member companies. This guidance will be released in the form of an Interim User Guide and will be made freely available on the CDISC website. Researchers around the world can leverage the User Guide to represent data in studies pertaining to COVID-19 to expedite the regulatory review process, reduce time to market, and drive operational efficiencies within their organizations. US FDA is aware of and observing the work of the task force.

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.