Clinical Data Interchange Standards Consortium

Clinical Data Interchange Standards Consortium (CDISC) is a global, non-profit organization that develops and supports global data standards for medical research. CDISC standards are designed to improve data quality, support data sharing and facilitate interoperability between systems to improve medical research and related areas of healthcare.

History

The Clinical Data Interchange Standards Consortium was founded in 1997 by a consortium of pharmaceutical companies and contract research organizations. The goal was to establish standards for the exchange of clinical trial data. The consortium has since grown to include over 300 member organizations from across the globe, including pharmaceutical companies, biotech firms, contract research organizations, academic institutions, and regulatory agencies.

Standards

CDISC develops and maintains a suite of standards that support the entire clinical research process from protocol through analysis and reporting. These include:

• Study Data Tabulation Model (SDTM): This is the standard for the organization and formatting of clinical trial data. It provides a standard format for the submission of data to regulatory authorities, facilitating data sharing and reuse.

• Analysis Data Model (ADaM): This standard defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses.

• Clinical Data Acquisition Standards Harmonization (CDASH): This standard defines a basic set of data collection fields for clinical trials, which are intended to be used in case report forms.

• Operational Data Model (ODM): This standard provides a format for the exchange, archiving and regulatory submission of clinical research data.

Benefits

The use of CDISC standards offers several benefits. They improve data quality, streamline data management, facilitate data sharing, and support cumulative learning from data. They also enable the automation of data processing, reducing the time and cost of developing new therapies.

See also

• Health Level 7
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Regulatory Affairs