What should changes to source records be?

• A. Erase and rewrite the entry
• B. Not obscuring the original entry, but can obscure
• C. Traceable, not obscuring the original entry, and explained if necessary.
• D. Changes must be made by sponsor only

Answer: (C)

Preserving data integrity in source records means every change must be traceable and not hide the original data. You should not erase or obscure what was originally entered. Instead, make the correction in a way that keeps the original entry readable and adds a clear record of what was changed, who made the change, when it was made, and why. For paper records, that typically means drawing a single line through the incorrect value, recording the corrected information nearby, and noting the date, the person’s initials, and the reason. For electronic systems, an audit trail automatically captures who changed what and when, along with the rationale. This traceability ensures reviewers can see both the original data and the correction. Changes aren’t restricted to sponsor personnel; the responsible investigator or delegated personnel who originated or supervised the data can make corrections as long as the process remains fully traceable and explained.