Certified Clinical Research Professional (CCRP) (CCRP) Free Practice Test

Question 1

When can an IRB/IEC review a study using expedited review?

A. For initial review of Phase III IND protocol

B. For initial review of a study using specimens with identifiers

C. For protocol changes involving more than minimal risk

D. For minor changes to previously approved protocol

Correct Answer: D

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Question 2

According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB after completion of the trial at the site?

A. The final subject enrollment log

B. The monitoring close-out visit report

C. The data safety monitoring summary

D. The final report

Correct Answer: D

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Question 3

A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard.
Before applying this change to all subjects, what must occur?

A. Obtain IRB/IEC approval

B. Train sub-investigators

C. Inform all subjects

D. Document change in study file

Correct Answer: A

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Question 4

An unconscious patient experiencing life-threatening cardiac arrhythmias has been admitted to an emergency room. No FDA-approved treatment is available, and no legal representative is present. The clinical investigator determined that the use of an investigational antiarrhythmic drug is required. In accordance with the CFR, who must certify the investigator's determination?

A. The sponsor's medical monitor

B. An independent physician

C. The sponsor's study monitor

D. A sub-investigator

Correct Answer: B

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Question 5

In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?

A. Three years

B. Five years

C. Two years

D. One year

Correct Answer: C

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Question 6

In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?

A. The CRO/site agreements

B. The Investigator's Brochure

C. The investigational pharmacy's requirements

D. The sponsor's written procedures

Correct Answer: D

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Question 7

According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?

A. Investigator/institution

B. DSMB

C. OHRP

D. Regulatory authority

Correct Answer: A

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Question 8

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

A. Ensure that all payments from sponsor have been received

B. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome

C. Provide the IRB/IEC a final report, but only if the study has a positive outcome

D. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report

Correct Answer: B

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Question 9

An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?

A. Report to sponsor

B. None

C. Report to FDA

D. Report to OHRP

Correct Answer: B

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SOCRA Certified Clinical Research Professional (CCRP) (CCRP) Free Practice Test