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For how long must an investigator retain study records after a marketing application is approved according to FDA requirements?

  1. 1 year

  2. 2 years

  3. 3 years

  4. 4 years

The correct answer is: 2 years

According to FDA regulations, investigators must retain study records for 2 years after a marketing application is approved. This is important for ensuring the integrity of clinical research and maintaining accurate documentation for future reference. Option A is too short of a period and may not provide enough time for thorough review and verification of study data. Similarly, option C may be too long and could pose a risk of losing important information or documentation. Option D is also too long and may not be necessary for maintaining the necessary records.