CDISC ODM
Also written as: ODM — Operational Data Model
Clinical Data Interchange Standards Consortium Operational Data Model, a vendor-neutral format for exchanging and archiving clinical trial data and metadata.
Full Definition
CDISC ODM (Operational Data Model) is an XML-based standard developed by the Clinical Data Interchange Standards Consortium for the interchange and archive of clinical trial data and metadata. In oncology informatics, ODM facilitates the exchange of complex cancer trial data between different electronic data capture systems, regulatory agencies, and research organizations. The standard supports both study design metadata and actual clinical data, enabling seamless integration of multi-site oncology trials. ODM is particularly valuable in cancer research where data must be shared across institutions while maintaining regulatory compliance and data integrity.
Usage
Usage note: Always specify 'CDISC ODM' on first use; may be abbreviated as 'ODM' in subsequent references within the same document.
In Context
- "The clinical data manager exported the oncology trial dataset in CDISC ODM format for regulatory submission." — Clinical trial documentation
- "Ensure all patient-reported outcome measures are properly mapped within the CDISC ODM structure before data transfer." — Data management protocol