RAC-US 試験問題を無料オンラインアクセス

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.Dose-ranging
• B.Active-controlled
• C.Placebo-controlled
• D.Cross-over

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

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

• A.ICH guidelines
• B.ISO 13485
• C.IEC 60601
• D.WHO guidelines

Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

• A.Marketing materials
• B.Safety issues
• C.Clinical trial data
• D.Intellectual properly

A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

• A.The time frame in which the patent will expire
• B.The stability of the drug in all zone conditions
• C.Doha Declaration in the TRIPS Agreement
• D.International import and export regulations