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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q22-Q27):

NEW QUESTION # 22
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

• A. For a minimum of 10 years after completion of the clinical study
• B. Until the product has been discontinued from marketing in all ICH regions
• C. For at least two years after the last approval of an application in an ICH region
• D. Three years after the last clinical study site was supplied with investigational drugs

Answer: C
NEW QUESTION # 23
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

• A. Concept development and early technical design
• B. Concept development and validation
• C. Early technical design and product release
• D. Product release and validation

Answer: A
NEW QUESTION # 24
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

• A. 30 C and 35% RH
• B. 30c C and 65% RH
• C. 30: C and 75% RH
• D. 25: C and 60% RH

Answer: C
NEW QUESTION # 25
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?

• A. Respond to the regulatory authority that the company will provide copies of the relevant
  QC records for batch release.
• B. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
• C. Ask that the regulatory authority provide the actual product subject to the complaint.
• D. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.

Answer: D
NEW QUESTION # 26
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

• A. Determination of primary mode of action
• B. Approved indications of the drug
• C. Determination of product design deliverables
• D. Guidance documents for the device

Answer: C
NEW QUESTION # 27
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