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Which is NOT a common issue the FDA finds during site inspection?

  1. Excessive patient compensation

  2. Protocol deviations

  3. Failure to follow investigational plan and signed investigator agreement

  4. Inadequate recordkeeping

The correct answer is: Excessive patient compensation

During site inspections, the FDA looks for any issues that may impact the safety, efficacy, and integrity of clinical trials. Excessive patient compensation is not a common issue the FDA finds during site inspections, as long as it is within the approved budget and not used as an incentive for participation. This option is incorrect because the other choices, including protocol deviations, failure to follow investigational plan and signed investigator agreement, and inadequate recordkeeping, are all common issues that the FDA frequently finds during site inspections. These issues can affect the validity and reliability of the trial results, and can also pose risks to the safety of study participants. Therefore, they are important for the FDA to identify and address during site inspections.