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Free RAC-US Exam Braindumps (page: 13)

Page 12 of 26
PDF with 100 Questions

Which of the following statements regarding export regulations for an approved product is CORRECT?

  1. The product must not be in accord with the specifications of the foreign purchaser.
  2. The product must not be in conflict with the laws of the country to which it is intended for export.
  3. The product must not be labeled on the outside of the shipping package that it is
    intended for export.
  4. The product must not be sold or offered for sale in domestic commerce.

Answer(s): B



During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

  1. Increase the frequency of monitoring visits.
  2. Inform the institution that granted a medical license to the Pi.
  3. Send a letter of complaint to the Ethics Committee that approved the site.
  4. Terminate the PI and inform the regulatory authorities.

Answer(s): D



A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.

What should be done. What action should the company take FIRST?

  1. Initiate testing immediately to ensure compliance.
  2. Consult with colleagues about the request.
  3. Contact the regulatory authority that issued this request and discuss the requirement.
  4. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.

Answer(s): C



A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

  1. Obtain a copy of the proposed regulation and analyze the impact.
  2. Inform the company's senior management and arrange an emergency meeting
  3. Consult with the company's legal department regarding options.
  4. Arrange for additional testing of the product at the testing facility.

Answer(s): A






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