Is data fabrication ever allowed?

• A. Never
• B. Sometimes with approval
• C. Only in simulated data
• D. Only in blinded studies

Answer: (A)

Maintaining data integrity means every data point in a trial truly reflects what was observed and is recorded accurately, verifiably, and traceably. Fabricating data—making up results or altering data to fit a desired outcome—violates ethical standards, GCP requirements, and participant safety. It undermines the scientific validity of the study, misleads investigators, sponsors, and regulators, and can lead to incorrect risk assessments or inappropriate approvals. Because there is no legitimate scenario where false data are acceptable in a clinical trial, data fabrication is never allowed. Simulated data can be used for training or methodological development, but it must be clearly labeled as simulated and kept separate from real trial data; it does not replace actual observations in a study.