roblem: Does your CTMS have audit trail functionality that tracks and logs all user activities, including access to records, changes, and deletions? 21CFR 11.10(e), an electronic system must have an audit trail that ensures traceability of all changes to data, including who made the change and when. This is crucial for maintaining data integrity and ensuring compliance with regulations. The audit trail should traceability for the "who," "what," "when," and "why" of data creation, modification, or deletion. As the audit trail serves as a safeguard to ensure that data can be verified in the event of an audit or inspection. Additionally, the audit trail should be generated automatically by the system and must not allow users to edit or delete it, ensuring data security and integrity. The data in the audit trail must be in a readable format for regulatory review or internal audits and should have the capability to search, filter, and export audit trail data by specific parameters. This will aid large clinical trials in having efficient data retrieval capabilities. Respond to this discussion with new ideas and sources. Need Professional Help?