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.


21 CFR 312.62 deals with which of the following?

  1. Investigational new drug application (IND)

  2. Bioavailability and bioequivalence

  3. Handling of controlled substances

  4. Investigator recordkeeping and reports

The correct answer is: Investigator recordkeeping and reports

21 CFR 312.62 specifically deals with the requirements for investigator recordkeeping and reports for clinical investigations of drug products. Options A, B, and C are incorrect because - Option A, Investigational new drug application (IND), is covered under 21 CFR 312.23 and 312.30. - Option B, Bioavailability and bioequivalence, is covered under 21 CFR 320. - Option C, Handling of controlled substances, is covered under 21 CFR 1301, not 21 CFR 312.62. Therefore, the correct answer is D because it is the only option that is directly related to investigator recordkeeping and reports.