RAC-US無料問題集「RAPS Regulatory Affairs Certification (RAC) US」

質問 1

A process is ultimately validated to ensure which of the following?

（A）The process consistently produces the desired results.

（B）The process meets the regulatory requirements.

（C）The process consistently meets the desired Quantity standards

（D）The process meets the quality system requirements.

正解：A 解答を投票する

質問 2

According to ICH, which of the following components of study information is NOT required in a clinical study report?

（A）Detailed CV of all investigators

（B）List of lECs or lRBs

（C）Randomization scheme and codes

（D）Protocol and protocol amendments

正解：A 解答を投票する

質問 3

Why is it necessary to run supplemental safety pharmacology studies?

（A）To comply with regulatory authority requirements related to clinical studies

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

（C）To substitute the utilization of GLP

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

正解：B 解答を投票する

質問 4

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）Three years after the last clinical study site was supplied with investigational drugs

（C）Until the product has been discontinued from marketing in all ICH regions

（D）For at least two years after the last approval of an application in an ICH region

正解：D 解答を投票する

質問 5

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）Approved indications of the drug

（B）Guidance documents for the device

（C）Determination of primary mode of action

（D）Determination of product design deliverables

正解：D 解答を投票する

質問 6

You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

（A）Advise the senior management to send a "Dear Dr." letter.

（B）Discuss with regulatory authorities to investigate how to have the off-label indication approved.

（C）File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

（D）No action is required since it is an off-label use.

正解：B 解答を投票する

質問 7

A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

（A）Relevance to regulations

（B）Scope and level of detail

（C）Expiration date

（D）Revision history

正解：A 解答を投票する

質問 8

A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

（A）Ask the trade association representative to provide an overview of the new product area to the marketing team.

（B）Obtain competitor research and provide the information to the management team.

（C）Summarize regulatory documents and history and provide the information to the management team.

（D）Obtain regulatory documents and history and provide the information to R&D.

正解：C 解答を投票する

質問 9

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

（A）Module 1

（B）Module 2

（C）Module 4

（D）Module 3

正解：B 解答を投票する

質問 10

A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

（A）Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.

（B）Review the regulatory guidelines to determine how to proceed.

（C）Request a meeting with the regulatory authority to discuss the application.

（D）Consult with the legal department to discuss the best course of action.

正解：C 解答を投票する

RAC-US 無料問題集「RAPS Regulatory Affairs Certification (RAC) US」

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