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 ?
Collaboration and inclusivity have always been bedrocks of CDISC's culture.
It's been done in a way with too much overhead, [that's] too chaotic, for too long." CDISC is advocating interoperable standards for clinical trial data to effectively streamline the process of validating some of the substances that go to the FDA for approval.
[7] Clinical Data Interchange Standards Consortium (CDISC), Electronic Source Data Interchange (eSDI) Group.
Beyond migrating or mapping proprietary data to CDISC standards, respondents said that a number of challenges pose significant demands on their already stretched resources, including: Development and support for new standards, processes and infrastructure; developing standards governance structures across functional areas; training people to implement the standards; and putting management processes in place to verify compliance with the new standards.
According to the purpose of how clinical trial data is used, CDISC provides various standard models.
The Computerized Diagnostic Interview Schedule for Children (CDISC) (Shaffer, 1992) is a structured, computerized interview used to determine whether youths meet DSM-IV-TR criteria for an alcohol or psychoactive substance use disorder.
He has served three terms as chair, Health Level 7, chair of ISO TC 215 WG2, and chair of the Joint Initiative Council (ISO, CEN, HL7, CDISC, IHTSDO, and GS1).
ViewPoint FUSE 4.2, an electronic data capture platform, produces submission-compliant output, including bookmarked and hyperlinked PDF case report forms, as well as data that is compliant with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM).
It is built on a service-oriented architecture (SOA) that adheres to open standards, such as CDISC and Web services, and maintains exposed APIs that create a platform on which other clinical development applications can connect.
Models for standard-setting include the Clinical Data Interchange Standards Consortium (CDISC 2004) and the Standards for Exchange of Nonclinical Data (SEND 2004).
However, LOINC is now being used in Digital Imaging and Communication in Medicine (DICOM) ultrasound (9) messages and in Clinical Data Interchange Standards Consortium (CDISC) pharmaceutical industry (10) messages to identify clinical and laboratory observations, respectively, and could well be used in clinical and research databases for the same purpose.