CITI Training Practice Exam

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21 CFR 312.57 pertains to which aspect of drug development?

Labeling and packaging
Recordkeeping requirements
Safety reporting
Quality control

The correct answer is: Recordkeeping requirements

21 CFR 312.57 pertains to recordkeeping requirements in drug development. This means that it outlines the regulations for maintaining accurate and complete records throughout the entire drug development process. It is important for companies to adhere to these regulations in order to ensure the safety and efficacy of their drugs. While labeling and packaging, safety reporting, and quality control are all important aspects of drug development, they are not specifically addressed in 21 CFR 312.57. Therefore, they are incorrect choices.