What should the investigator do for any deviation from approved protocol?

• A. Hide it.
• B. Document and explain any deviation.
• C. Document but not explain.
• D. Do not report to anyone.

Answer: (B)

Deviations from the approved protocol must be documented and explained. This creates an accurate audit trail, allows assessment of potential risks to participant safety and the integrity of trial data, and supports appropriate decisions about corrective actions or protocol amendments. The investigator should record what happened, when it occurred, who was involved, the reason for the deviation, and any impact on safety or data, then ensure the deviation is reviewed according to the sponsor’s and ethics committee’s requirements and reflected in the trial documentation. Concealing a deviation or documenting without explanation (or failing to report it) undermines subject safety and regulatory compliance.