CDISC


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CDISC

Clinical Data Interchange Standards Consortium. A global, open, multidisciplinary, non-profit organisation that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  CDISC standards are vendor-neutral, platform-independent and freely available.
References in periodicals archive ?
In 2014, the FDA mandated that, starting in December 2016, all new drug applications must be submitted electronically and in accordance with CDISC standards.
Prior to joining, Chiltern has been following CDISC standards with experience in reporting over 100 studies using the SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) models.
CDISC currently has six production-level standards that are published for implementation by the clinical research community.
Wherever possible, appropriate existing standards (including LOINC and HL 7 code lists) were used because CDISC is committed to working with other professional groups to share information and minimize duplication of effort.
Peddicord's three-year term on the CDISC board begins January 1, 2013.
With the ClinSpark[TM] system being the only Phase I eSource system in the world to have achieved CDISC ODM certification, we have the confidence in knowing that we can speak the same language as our partners in the clinical research ecosystem.
Hardison will speak at the CDISC Asia-Pacific/Japan Interchange 2014 on July 31 in Tokyo, an event that runs from July 28 through Aug.
Working with a vendor with the expertise to ensure that your clinical data is correctly converted and migrated in accordance to CDISC Standards will avoid delays in the review process and avoid valuable lost time to market.
This User Guide describes the most common research concepts relevant to studies of Alzheimer's disease and mild cognitive impairment, and gives guidance on the necessary metadata to represent in a way that is consistent with CDISC standards.
Octagon is fortunate to have two of its clinical data strategy experts presenting at the upcoming CDISC Interchange in Stockholm," said James C.
DATATRAK is a leader in driving CDISC standards compliance with seven of the standards supported - CDASH, Define-XML, LAB, ODM, SDTM, SEND and Terminology.
Initiating the study design and protocol process in a structured manner while incorporating CDISC standards use drives efficiency throughout the entire study life," said David Gemzik, Chair of the Protocol Representation Group.