What is Clinical Data Interchange Standards Consortium (CDISC)?
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CDISC, which stands for Clinical Data Interchange Standards Consortium, is a global non-profit organization that develops and maintains standards for the collection, exchange, submission, and archiving of clinical research data. CDISC standards are used to ensure consistency, quality, and interoperability in the way clinical trial data is collected, managed, and shared across different stakeholders in the pharmaceutical, biotechnology, and medical research industries.
CDISC standards are designed to streamline the process of conducting clinical trials and sharing the resulting data for regulatory submissions, research collaborations, and other purposes. These standards cover a wide range of areas within clinical research, including data collection, metadata, terminology, analysis, and reporting. The goal is to make clinical data more structured, standardized, and ready for use in various applications.
Some of the key CDISC standards include
1. SDTM (Study Data Tabulation Model): SDTM defines a standardized structure and format for organizing and presenting clinical trial data, making it easier to exchange data between different systems and organizations. SDTM provides a common framework for presenting data such as demographics, adverse events, laboratory results, and more.
2. ADaM (Analysis Data Model): ADaM focuses on the structure and format of analysis datasets used in clinical trial analysis and reporting. It provides guidelines for creating datasets that are consistent, well-defined, and suitable for statistical analysis.
3. CDASH (Clinical Data Acquisition Standards Harmonization): CDASH provides guidelines for collecting clinical trial data using a consistent set of case report form (CRF) fields and structures. This standard helps improve data quality and consistency during data collection.
4. Controlled Terminology: CDISC maintains standardized terminology, known as controlled terminology, which ensures that medical concepts and variables are defined consistently across different trials and studies. This helps to prevent ambiguity and allows for more accurate data exchange and analysis.
5. Define-XML: Define-XML is a standard format for describing the content and structure of datasets and data variables, making it easier to understand and interpret the data included in a submission package.
CDISC standards are widely adopted in the pharmaceutical and medical research industries, especially for regulatory submissions to health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Adhering to CDISC standards helps ensure that clinical trial data is of high quality, can be easily integrated with other data sources, and supports efficient analysis and decision-making throughout the drug development process.
