RAPS RAC Regulatory Affairs Certification RAC-GS Questions & Answers

• Question 31:

  According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

  A. Class A

  B. Class B

  C. Class C

  D. Class D

  Correct Answer: C

• Question 32:

  A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

  A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

  B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

  C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

  D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

  Correct Answer: A

• Question 33:

  In which section of the ICH Common Technical Document will the overview of clinical data appear?

  A. Module 1

  B. Module 2

  C. Module 3

  D. Module 4

  Correct Answer: BC

• Question 34:

  During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

  A. ISO 14971 risk analysis

  B. Failure mode and effect analysis

  C. Fault tree analysis

  D. Hazard and operability study

  Correct Answer: A

• Question 35:

  According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

  A. 3

  B. 5

  C. 7

  D. 9

  Correct Answer: C

• Question 36:

  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?

  A. Obtain a copy of the proposed regulation and analyze the impact.

  B. Inform the company's senior management and arrange an emergency meeting

  C. Consult with the company's legal department regarding options.

  D. Arrange for additional testing of the product at the testing facility.

  Correct Answer: A

• Question 37:

  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?

  A. Increase the frequency of monitoring visits.

  B. Inform the institution that granted a medical license to the Pi.

  C. Send a letter of complaint to the Ethics Committee that approved the site.

  D. Terminate the PI and inform the regulatory authorities.

  Correct Answer: D

• Question 38:

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

  A. The product must not be in accord with the specifications of the foreign purchaser.

  B. The product must not be in conflict with the laws of the country to which it is intended forexport.

  C. The product must not be labeled on the outside of the shipping package that it is intendedfor export.

  D. The product must not be sold or offered for sale in domestic commerce.

  Correct Answer: B

• Question 39:

  The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon.

  Which is the most appropriate action for the regulatory affairs professional to take FIRST?

  A. Transfer the notice of the upcoming international monograph change to QA for further processing.

  B. Prepare the international monograph change submission first and then prepare the local change when required.

  C. Confirm that the international monograph change is not related to local pharmacopeia.

  D. Analyze the impact of the international monograph change on the local pharmacopeia.

  Correct Answer: AB

• Question 40:

  In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

  A. Volume and material

  B. Compatibility and safety

  C. Safety and efficacy

  D. Efficacy and material

  Correct Answer: B