Which red flags might indicate data manipulation in GLP studies?

• A. Inconsistent timestamps
• B. Missing original data
• C. Repeated edits
• D. Lack of audit trail

Answer: (B)

In GLP studies, keeping the original, raw data is essential so results can be verified, audited, and reproduced. Missing original data is the strongest red flag because without the actual source records you cannot confirm what was measured, when, or how it was processed. This gaps open the door to questioning or disguising what happened to the data, making any manipulation difficult or impossible to detect.

Other signs can raise concern but are not as definitive on their own. Inconsistent timestamps might occur from system quirks or data transfer processes and don’t prove manipulation by themselves. Repeated edits could indicate post‑collection changes, but those edits must be properly documented and justified with an auditable trail. A lack of an audit trail is also serious because it removes traceability to who changed what and when, but even with an audit trail, the absence of the original data leaves the integrity of the findings un verifiable.