CITI Training Practice Exam

The FDA requires retention of investigational drug study records for at least 2 years after the investigational drug's approval by the FDA. This is to ensure that the records are available for review and inspection during the drug approval process. A 5 years following the study completion is incorrect because the records may be needed for longer than 5 years, especially if there are questions or concerns during the drug approval process. C: 10 years from the study start date is incorrect because the approval date may not coincide with the study start date. D: Indefinitely, as long as the drug is on the market is incorrect because the FDA requires a specific timeframe for record retention, and not an indefinite period.