Under the second-tier regulations, which statement best describes 21 CFR Part 58 (subparts A-K)?

Under the second-tier regulations, which statement best describes 21 CFR Part 58 (subparts A-K)?

• A. Good laboratory practice for nonclinical laboratory studies
• B. Clinical trial reporting requirements
• C. Good manufacturing practice for devices
• D. Post-market surveillance requirements

Answer: (A)

The main idea tested is what 21 CFR Part 58 Subparts A–K regulates. These second-tier regulations establish Good Laboratory Practice for nonclinical laboratory studies, outlining how such studies should be planned, conducted, monitored, recorded, reported, and audited to ensure data quality and reliability for regulatory submissions. It covers the responsibilities of the sponsor and the test facility, the role of the quality assurance unit, required documentation and archiving of raw data, and the format of final study reports. This makes the description of Good Laboratory Practice for nonclinical laboratory studies the best fit for these subparts. Clinical trial reporting, device manufacturing, and post-market surveillance are governed by different parts and regulations, not GLP.

The main idea tested is what 21 CFR Part 58 Subparts A–K regulates. These second-tier regulations establish Good Laboratory Practice for nonclinical laboratory studies, outlining how such studies should be planned, conducted, monitored, recorded, reported, and audited to ensure data quality and reliability for regulatory submissions. It covers the responsibilities of the sponsor and the test facility, the role of the quality assurance unit, required documentation and archiving of raw data, and the format of final study reports. This makes the description of Good Laboratory Practice for nonclinical laboratory studies the best fit for these subparts. Clinical trial reporting, device manufacturing, and post-market surveillance are governed by different parts and regulations, not GLP.