SOCRA CCRP Practice Exam

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Which of the following is a criterion for Phase 1 protocol as required by the FDA?

Maximum number of subjects involved
Color scheme of study material
List of potential sponsors
Predicted stock value impact

The correct answer is: Maximum number of subjects involved

The criterion for Phase 1 protocol required by the FDA is the maximum number of subjects involved. This is because Phase 1 trials are focused on testing the safety and tolerability of a new drug or treatment in a small group of healthy individuals. Therefore, it is important to limit the number of participants in order to minimize potential risks and gather manageable data. Option B, the color scheme of study material, and option C, the list of potential sponsors, are not relevant criteria for Phase 1 protocols. Option D, the predicted stock value impact, may be a consideration for companies conducting a clinical trial, but it is not a required criterion by the FDA.