SOCRA CCRP Practice Exam

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What do FDA regulations require for monitor selection?

  1. Sponsors must select monitors with specific certifications

  2. Sponsors shall select monitors qualified by training and experience

  3. All monitors must have a medical degree

  4. Monitors must be selected randomly

The correct answer is: Sponsors shall select monitors qualified by training and experience

FDA regulations require that sponsors choose qualified monitors who have appropriate training and experience. This is to ensure that the monitors have the proper knowledge and skills to effectively oversee the clinical trial. Option A is incorrect because while specific certifications may be helpful, they are not necessarily required by the FDA. Option C is incorrect because having a medical degree is not a requirement for monitors. Option D is also incorrect because monitors should be carefully chosen based on their qualifications, rather than being selected randomly.

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