Certified Clinical Research Professional (CCRP)

Question 1

A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator's proposed patient recruitment materials?

A. The FDA

B. A scientific review board

C. The Office for Human Research Protections (OHRP)

D. An IRB/IEC

Correct Answer: D

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Question 2

What is included in the Statement of Investigator (Form FDA 1572)?

A. A statement agreeing to comply with FDA regulations

B. A statement describing preclinical and human safety data

C. A statement disclosing investigator financial interests

D. A statement responding to FDA inspection observations

Correct Answer: A

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Question 3

Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?

A. It is an application to export the investigational drug

B. It is an application for the sponsor to sell the drug for profit

C. It includes a disclosure of the financial interests and arrangements of clinical investigators

D. It includes the rationale for human testing and a description of the general investigational plan

Correct Answer: D

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Question 4

Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?

A. India

B. China

C. Switzerland

D. Brazil

Correct Answer: A

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Question 5

A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?

A. Number of staff members

B. Available storage square footage

C. Storage facility temperature range

D. Storage cost

Correct Answer: C

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Question 6

For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?

A. You might develop symptoms of myalgia, arthralgia, and tiredness

B. You might experience adverse events of myalgia, arthralgia, and lethargy

C. You might have some muscle aches, joint pain, and tiredness

D. You might have some mild side effects while taking the investigational drug

Correct Answer: C

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SOCRA Certified Clinical Research Professional (CCRP) - CCRP Exam Practice Test

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