What must be documented regarding data changes to electronic systems?

• A. All data changes should be documented.
• B. Data changes may be made without any record.
• C. Documentation is optional.
• D. Only deletions require documentation.

Answer: (A)

Documenting every modification to data in electronic systems is essential to preserve data integrity and traceability. In practice, electronic systems used in trials should maintain an auditable trail that shows exactly what changed, who made the change, and when it occurred. This supports accountability and regulatory compliance, such as requirements under 21 CFR Part 11 for electronic records and signatures. Since deletions are also changes, they must be captured too—not just some edits. Therefore, all data changes should be documented to provide a complete history of the data.