Which CDISC model facilitates the archive and interchange of clinical research metadata and is compliant with 21 CFR Part II?

The Operational Data Model (ODM) is designed for the archive and interchange of clinical research metadata, making it essential for managing data in a structured and standardized way. It specifically addresses the needs for data submission and data interchange in clinical trials, ensuring compliance with regulatory requirements such as 21 CFR Part 11, which governs electronic records.

This model supports the exchange of both metadata and clinical trial data, allowing for the seamless sharing of information between different stakeholders in the clinical research process. By focusing on the metadata associated with clinical trials, the ODM facilitates better awareness and utilization of data collected during the trial, thereby promoting data integrity and consistency.

In contrast, other models like the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) are primarily concerned with the format and structure of the actual clinical trial data, promoting standardized datasets for submission to regulatory authorities rather than focusing specifically on the interchange of metadata.