ACRP CCRC EXAM NEWEST 2025
ACTUAL EXAM QUESTIONS AND
CORRECT ANSWERS (VERIFIED
ANSWERS) | ALREADY GRADED A+
What would be the first priority for an investigator when a
subject wishes to withdraw prematurely from the trial?
Correct Answer Try to obtain the subject's reason for
withdrawal.
A blood sample collection is required to screen for
bloodborne pathogens before subject could be enrolled in
a study. Where will subjects find information of the
procedures and any foreseeable risks or inconveniences?
Correct Answer ICF
Per ICH, an IRB/IEC must keep correspondence for at
least how long after the completion of a clinical trial?
Correct Answer 3 years
A CRA notices during an onsite visit that the date on
IRB/IEC approval letter for a protocol is prior to the
effective date indicated on the cover page of the protocol
and the signatures of the investigator and sponsor. What
should the CRA do FIRST? Correct Answer Confirm dates
of initial receipt of the sponsor protocol and the IRB/IEC
submission dates.
,A CRO recently switched from paper CRF to an EDC
system. The EDC system must conform to the established
requirements for: Correct Answer validation, accuracy,
reliability, and completeness.
When should a research study involving human subjects
be registered in a publicly accessible database? Correct
Answer Before recruiting the first subject
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 Answer obtain 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 Answer
The 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 Answer a
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 Answer PI
Part of a sponsor's responsibility pertaining to electronic
trial data handling is to Correct Answer maintain an audit
trail, data trail, and edit trail.
Which entity is primarily charged with considering subject
rights and well-being during clinical trials? Correct Answer
Institutional 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 Answer 1. 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 Answer False
An Unexpected Adverse drug reaction is: Correct Answer
A reaction that is not consistent with the applicable
product information
ICH safety definitions can be found in Correct Answer ICH
E2A
An Adverse Event (AE) that is severe in intensity Correct
Answer May 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 Answer True
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 Answer Serious 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
Answer False
In pre-market approval studies, all noxious and unintended
responses to a medicinal product even possibly related to
any dose should be considered: Correct Answer Adverse
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 Answer A serious adverse event
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