CITI Training Practice Exam

Disable ads (and more) with a membership for a one time $2.99 payment

Master CITI Training with our comprehensive practice exam. Boost your research skills, ensure compliance, and excel in your field. Start now for success!

Each practice test/flash card set has 50 randomly selected questions from a bank of over 500. You'll get a new set of questions each time!

Practice this question and more.

Where can detailed requirements for the content and format of an IND be found?

21 CFR 50
21 CFR 312
21 CFR 1571
21 CFR 1572

The correct answer is: 21 CFR 312

The requirements for the content and format of an IND (Investigational New Drug application) can be found in 21 CFR (Code of Federal Regulations) 312. This regulation specifically outlines the information and documentation that must be included in an IND submission for approval from the FDA. It includes details about the proposed drug, its manufacturing process, and the clinical data and studies conducted. Therefore, options A, C, and D are incorrect as they refer to regulations that do not pertain to IND submissions. Option A refers to human subjects protection regulations, option C refers to electronic submission of import and export data, and option D refers to data quality and integrity requirements for clinical trials. Only option B, 21 CFR 312, covers the specific requirements for an IND.