최신SOCRA Certified Clinical Research Professional (CCRP) - CCRP무료샘플문제
문제1
While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?
While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?
정답: B
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문제2
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
정답: C
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문제3
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
정답: D
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문제4
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
정답: D
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문제5
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
정답: A
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문제6
A sponsor is permitted to charge for an investigational drug but must provide what documentation?
A sponsor is permitted to charge for an investigational drug but must provide what documentation?
정답: A
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문제7
An IND application must contain all EXCEPT:
An IND application must contain all EXCEPT:
정답: A
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문제8
Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?
Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?
정답: B
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문제9
In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:
In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:
정답: C
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