Which of the following is true about Good Laboratory Practice (GLP) standards?

• A. They represent federal law, carrying penalties or other sanctions if fraud is detected.
• B. They are purely voluntary guidelines with no legal consequences
• C. They apply only to human clinical trials
• D. They require all studies to be single-blinded

Answer: (A)

GLP standards are regulatory requirements that ensure how nonclinical safety studies are planned, conducted, monitored, recorded, and reported so that the data regulators rely on are credible and reliable. They are enforceable federal regulations, meaning there can be penalties or sanctions for fraud or noncompliance. This makes GLP an obligation, not just a suggestion. GLP applies to nonclinical safety studies used to support regulatory submissions, not to human clinical trials (which fall under Good Clinical Practice). Blinding, such as single-blinding, is a study design choice and is not a universal GLP requirement.