Description: CDISC is a standard supporting clinical and non-clinical research processes from end to end, focusing on the core principles for defining health data standards and include models, domains and specifications for data representation. Additional information: The Clinical Data Interchange Standards Consortium (CDISC) is a global, non-profit organization that develops and supports global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are designed to provide a consistent, reliable and efficient method for the collection, management, storage and reporting of clinical research data. The CDISC specification provides a standardized format for the exchange of clinical data. This includes the structure, content, and semantics of clinical research data, as well as the metadata that describes this data. The CDISC standards are used to facilitate the sharing, integration, pooling, and analysis of data collected during different stages of clinical research, including pre-clinical, clinical, post-marketing, and observational studies. The CDISC suite of standards includes the Study Data Tabulation Model (SDTM), the Analysis Data Model (ADaM), the Operational Data Model (ODM), the Clinical Data Acquisition Standards Harmonization (CDASH), and the Biomedical Research Integrated Domain Group Model (BRIDG), among others. These standards cover various aspects of clinical research data, including the design of case report forms, the representation of collected data, the archiving of data, the interchange of data, and the submission of data to regulatory authorities. The CDISC specification is widely used in the pharmaceutical industry and is endorsed by the U.S. Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the submission of data in support of new drug applications. By providing a common language for clinical research data, the CDISC standards aim to improve data quality, streamline data processing, and increase transparency and interoperability in clinical research. Example: 1. Clinical Trials: CDISC standards are used in clinical trials to ensure that data is collected, stored, and reported in a consistent and reliable manner. This allows researchers to compare and analyze data from different trials, which can lead to new discoveries and improvements in patient care. 2. Drug Development: Pharmaceutical companies use CDISC standards during the drug development process. This ensures that the data collected during preclinical and clinical studies is consistent and can be easily shared with regulatory agencies like the FDA. 3. Regulatory Submissions: CDISC standards are used in regulatory submissions to ensure that the data provided to regulatory agencies is consistent and reliable. This makes it easier for these agencies to review and approve new drugs and medical devices. 4. Data Integration: CDISC standards are used to integrate data from different sources. This can include data from electronic health records, clinical trials, and other research studies. This allows researchers to analyze large amounts of data and make more informed decisions about patient care. 5. Data Sharing: CDISC standards make it easier to share clinical data with other researchers, healthcare providers, and patients. This can lead to more collaboration and faster advancements in medical research. 6. Data Management: CDISC standards are used in data management to ensure that clinical data is stored and managed in a consistent and reliable manner. This makes it easier to retrieve and analyze data when needed. 7. Real-World Evidence Studies: CDISC standards are used in real-world evidence studies to ensure that data collected from real-world settings is consistent and reliable. This allows researchers to analyze this data and apply the findings to improve patient care. LOST view: TVA-Health Patient Summary Enablers [Motivation] Identifier: http://data.europa.eu/dr8/egovera/ClinicalDataInterchangeStandardsConsortium-CDISCContract EIRA traceability: eira:TechnicalInteroperabilityAgreementContract EIRA concept: eira:SolutionBuildingBlock Last modification: 2023-08-04 dct:identifier: http://data.europa.eu/dr8/egovera/ClinicalDataInterchangeStandardsConsortium-CDISCContract dct:title: Clinical Data Interchange Standards Consortium - CDISC Contract