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 ?
The Therapeutic Area User Guide describes the most common biomedical concepts relevant to Vaccine studies, and the necessary metadata to represent such data consistently with CDISC Standards.
A slightly smaller percentage believed CDISC standards will improve regulatory compliance over the long run.
The CDISC standards will help us to ensure that we are all using a common language, which will then usher in an era where we can automate quality improvement, trial matching, seamless integration of data into trials, and streamline the process of improving the care, survival, and quality of life of our patients.
In 2014, the FDA mandated that, starting in December 2016, all new drug applications must be submitted electronically and in accordance with CDISC standards.
The basic difficulty in transforming CRF observations to CDISC SDTM tables comes from the different data structures.
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.
The goal of the CFAST initiative is to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health," said CDISC Chief of Staff Dr.
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.
And the refusal cited above is arguably the highest profile example of the agency stressing the importance of standardized datasets and the implementation of CDISC data standards.
The US Food and Drug Administration Binding Guidance requires that sponsors whose studies start after December 17, 2016, must submit data in FDA-supported CDISC formats listed in the FDA Data Standards Catalog.