최신SOCRA Certified Clinical Research Professional (CCRP) - CCRP무료샘플문제
문제1
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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문제2
For a Significant Risk device study, an investigator must report within 5 working days which event?
For a Significant Risk device study, an investigator must report within 5 working days which event?
정답: B
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문제3
Why would a Phase IV study be conducted?
Why would a Phase IV study be conducted?
정답: A
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문제4
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
정답: A
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문제5
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
정답: A
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문제6
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?
정답: B
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문제7
After completion of a Phase III trial, which document should IRB/IEC retain?
After completion of a Phase III trial, which document should IRB/IEC retain?
정답: C
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문제8
Which of the following identifies content that should be included in a clinical research protocol?
Which of the following identifies content that should be included in a clinical research protocol?
정답: C
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문제9
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 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?
정답: D
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문제10
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
정답: C
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