What regulatory compliance aspect is addressed by the Operational Data Model (ODM)?

The Operational Data Model (ODM) is specifically designed to facilitate the submission of clinical trial data and support regulatory compliance, particularly with respect to the electronic submission of data to regulatory agencies like the FDA. One of the key regulatory aspects that ODM addresses is the requirements set forth under FDA 21 CFR Part 11, which pertains to electronic records and electronic signatures. This regulation establishes the criteria under which electronic records and electronic signatures can be considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.

By adopting ODM, organizations can ensure that their data management processes comply with these regulations, helping to maintain data integrity, ensuring traceability of data changes, and establishing proper security measures. Therefore, the significance of the ODM in relation to regulatory compliance lies primarily in its alignment with these specific FDA regulations, crucial for the acceptance and validity of electronic data submissions in clinical trials.