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CCRP Practice Questions With 100% Correct Answers
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CCRP Practice Questions With 100% Correct Answers
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CCRP Practice Questions With100% Correct Answers
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol
therapy was initiated. The subject showed significant improvement in his clinical condition, and
regained consciousness. The Investigator should inform the subject about the study and: correct
answerobtain consent from the subject for the study.
After completion of a study, the final trial close-out monitoring report prepared by the CRA should
be filed in which of the following stakeholder files? correct answerThe sponsor's files
A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval.
The site can begin enrolling subjects after: correct answera signed clinical trial agreement between the
site and sponsor is in place.
In a multi-arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk
of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC?
correct answerPI
,Part of a sponsor's responsibility pertaining to electronic trial data handling is to correct answermaintain
an audit trail, data trail, and edit trail.
Which entity is primarily charged with considering subject rights and well-being during clinical
trials? correct answerInstitutional Review Board (IRB)/Independent Ethics Committee (IEC)
Which of the following would be considered a vulnerable population requiring special consideration by
an IRB/IEC? correct answer1. Medical, pharmacy, dental, and nursing students
2. Prisoners
4. Serving military personnel
T or F: The terms "serious" and "severe" are synonymous according to ICH correct answerFalse
An Unexpected Adverse drug reaction is: correct answerA reaction that is not consistent with
the applicable product information
ICH safety definitions can be found in correct answerICH E2A
An Adverse Event (AE) that is severe in intensity correct answerMay not meet the definition of serious
, T or F: Information discovered during the course of a clinical investigation that might materially
influence the benefit-risk assessment of the investigation/product may necessitate rapid communication to
regulatory authorities. correct answerTrue
Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after
participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a
possible side effect. This is considered a/an: correct answerSerious Adverse Drug Reaction
T or F: A subject in your diabetes research study developed colon cancer, which the Investigator has
determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered
a serious adverse event because it is life threatening. correct answerFalse
In pre-market approval studies, all noxious and unintended responses to a medicinal product even
possibly related to any dose should be considered: correct answerAdverse Drug Reaction
You were just informed that you have a research patient that is receiving intensive treatment in an
emergency room for allergic bronchospasm. This should be considered as: correct answerA serious
adverse event
After a Serious Adverse Event (SAE) has occurred, how should you list the subject identification on
the immediate and follow-up reports? correct answerBy their subject identification number
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