ACRP CP CERTIFICATION EXAM | ALL
QUESTIONS AND CORRECT ANSWERS |
ALREADY GRADED A+ | VERIFIED
ANSWERS | LATEST VERSION (JUST
RELEASED)
New safety information has become available from the Sponsor about the
IP being used in a clinical trial. The Investigator must ---------CORRECT
ANSWER-----------------submit a revised ICF to the IRB/IEC noting the new
safety information.
A medical student is approached by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which of the
following increases risk to the subject? ---------CORRECT ANSWER----------
-------Consenting in the presence of figure of authority
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 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
3. 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
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