Free Access to RAPS.RAC-US.v2022-06-02.q33 with Valid Practice Test (Page 7)

Question 26

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.

Question 27

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A.Request documentation from the sub-contractor.
B.Ask the vendor to take responsibility.
C.Request an inspection from a regulatory authority.
D.Document and perform audits.

Question 28

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

A.The process meets the regulatory requirements.
B.The process meets the quality system requirements.
C.The process consistently meets the desired Quantity standards
D.The process consistently produces the desired results.

Question 29

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

Question 30

According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

A.Production of Intermediate(s)
B.Introduction of the API starting material
C.Physical processing and packaging
D.Isolation and purification

Question 26

Question 27

Question 28

Question 29

Question 30

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