Regulatory Affairs Certification (RAC) US (RAC-US) Free Practice Test

Question 1

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

A. "Product X is safe for arthritis and without side effects."

B. "Product X is effective in all patients with arthritis."

C. "Product X is effective for the treatment of arthritis."

D. "Product X is a guaranteed cure for arthritis."

Correct Answer: C

Question 2

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. Results of a three-year, post-market patient survey indicate the product is superior.

B. In vitro studies show the product to be superior.

C. Government survey data indicate the product is superior.

D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Correct Answer: D

Question 3

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

A. Class C

B. Class B

C. Class D

D. Class A

Correct Answer: A

Question 4

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

A. Product distribution

B. Plasma pooling

C. Individual plasma donation

D. Plasma fractionation

Correct Answer: A

Question 5

Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

A. Placebo-controlled

B. Active-controlled

C. Cross-over

D. Dose-ranging

Correct Answer: C

Question 6

Which term does NOT describe the same concept as the others?

A. Monoclonal antibody

B. Biosimilars

C. Subsequent entry biologics

D. Follow-on protein products

Correct Answer: A

Question 7

Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

C. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.

D. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

Correct Answer: D

Question 8

The requirements for document control are located in which of the following documents?

A. IEC 60601

B. WHO guidelines

C. ICH guidelines

D. ISO 13485

Correct Answer: D

Question 9

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A. Regulatory agency

B. Quality assurance

C. Quality improvement

D. Clinical affairs

Correct Answer: B

Question 10

Why is it necessary to run supplemental safety pharmacology studies?

A. To substitute the utilization of GLP

B. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

C. To comply with regulatory authority requirements related to clinical studies

D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority

Correct Answer: B

Welcome to TestSimulate

RAPS Regulatory Affairs Certification (RAC) US (RAC-US) Free Practice Test