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

Page: 1 / 14
Total 132 questions

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Question 1

While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?

A. Only the signatures of the person obtaining consent and the witness appear on the copy of the summary of the short form consent B. A copy of the consent document was not provided to a subject C. The sponsor-generated informed consent template is missing required elements D. A subject's signature is missing on the copy of the summary of the short form consent

Discussion 0

Correct Answer: B Vote an answer

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Question 2

In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?

A. Sponsor B. Investigator C. Regulatory authority D. Institution

Discussion 0

Correct Answer: A Vote an answer

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Question 3

Which of the following statements about the investigator's brochure is correct?

A. It provides documents that permit the evaluation of the conduct of the study and the quality of the data B. It includes financial disclosure information from investigators C. It consists of the instructions for the investigator to conduct the study D. It contains a summary of the pharmacological and toxicological effects of the drug in animals, and to the extent known, in humans

Discussion 0

Correct Answer: D Vote an answer

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Question 4

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 experience adverse events of myalgia, arthralgia, and lethargy B. You might develop symptoms of myalgia, arthralgia, and tiredness C. You might have some muscle aches, joint pain, and tiredness D. You might have some mild side effects while taking the investigational drug

Discussion 0

Correct Answer: C Vote an answer

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Question 5

An investigator reports a serious adverse event suspected to be drug-related. By CFR, the sponsor must notify FDA no later than:

A. 7 days B. 10 days C. 15 days D. 1 day

Discussion 0

Correct Answer: A Vote an answer

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Question 6

If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:

A. Sponsor and IRB/IEC within five days B. Sponsor and IRB/IEC within seven days C. Sponsor and IRB/IEC immediately, then update later D. IRB/IEC immediately, then sponsor when full details are available

Discussion 0

Correct Answer: C Vote an answer

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Question 7

Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?

A. The FDA may inspect them at reasonable times, in a reasonable manner, and may take copies of IRB
/IEC records B. The FDA may inspect them only if the IRB/IEC formally requests inspection C. The FDA may inspect them at reasonable times, in a reasonable manner, but may not take copies unless requested with an affidavit D. The FDA does not have regulatory authority to inspect them

Discussion 0

Correct Answer: A Vote an answer

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Question 8

Upon completion of a study, the investigator should do which of the following?

A. Provide the IRB/IEC a final report, but only if the study has a positive outcome B. Ensure that all payments from sponsor have been received C. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report D. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome

Discussion 0

Correct Answer: D Vote an answer

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Question 9

Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?

A. The sponsor is qualified to provide oversight of the trial B. The selection of subjects is equitable C. A plan for the publication of study results is in place D. The investigator has adequate access to patients eligible for the trial

Discussion 0

Correct Answer: B Vote an answer

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Question 10

After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?

A. The sponsor B. The investigator C. The IRB/IEC D. The study coordinator

Discussion 0

Correct Answer: A Vote an answer

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Total 132 questions

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