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SOCRA Certified Clinical Research Professional (CCRP) - CCRP Exam Questions

Page: 1 / 15
Total 132 questions

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QUESTION NO: 1
The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?

A. 5 years B. 2 years C. 15 years D. 3 years

Correct Answer: B

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QUESTION NO: 2
Which of the following is an example of an additional protection required when conducting research on children?

A. The investigator must obtain age-appropriate assent as determined by the IRB/IEC B. The study must be approved by a central pediatric IRB C. Parents must be present during all procedures D. There must be an impartial advocate present during the consent process

Correct Answer: A

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QUESTION NO: 3
After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

A. The regulatory authority B. The sponsor C. The IRB/IEC D. The Data Safety Monitoring Board

Correct Answer: B

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QUESTION NO: 4
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:

A. Generate audit trails B. Maintain accurate records throughout retention C. Customize access rights D. Print a complete paper copy

Correct Answer: D

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QUESTION NO: 5
Sponsor must maintain drug disposition records for how long after marketing approval?

A. 1 year B. 5 years C. 2 years D. 3 years

Correct Answer: C

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QUESTION NO: 6
Upon completion of a study, the investigator should do which of the following?

A. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's 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. Provide the IRB/IEC a final report, but only if the study has a positive outcome

Correct Answer: A

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QUESTION NO: 7
According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?

A. The subject or else the subject's legally authorized representative; the witness B. The subject or else the subject's legally authorized representative C. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness D. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee

Correct Answer: A

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QUESTION NO: 8
Which of the following statements about the investigator's brochure is correct?

A. It includes financial disclosure information from investigators B. It provides documents that permit the evaluation of the conduct of the study and the quality of the data 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

Correct Answer: D

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QUESTION NO: 9
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?

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

Correct Answer: C

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Page: 1 / 15
Total 132 questions

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