ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS
AND CORRECT ANSWERS|AGRADE
What document would an investigator reference to learn more about the p... [Show More] revious clinical and nonclinical
results of studies of the IP? - answer IB
When considering participation in a study, the investigator should determine if he/she: -answer sees
enough patients who would qualify for the study.
When would an impartial witness be needed during the consent process for an illiterate subject? - answer
To observe the consent process
During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the
study visit schedule and assessments? - answer Electronic medical record
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion
criteria is a score of 25 or less on a psychometric test, a research-specific tool which measures
cognitive ability. Which of the following individuals can administer the psychometric test to the potential
subjects? - answer A research assistant who is certified to administer the psychometric test
A research study, in which there is no intended clinical benefit to the subject, is being submitted to the
IRB/IEC. What benefit information should be included in the ICF? - answer Wording indicating that there is
no expected benefit should be included.
A research subject's responsibilities for study participation should be described in the: - answer ICF
New safety information has become available from the Sponsor about the IP being used in a clinical trial.
The Investigator must: - 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? - 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? - 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? - answer ICF
Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical
trial? - 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? - 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: - answer validation, accuracy, reliability, and completeness.
When should a research study involving human subjects be registered in a publicly accessible database? -
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: - 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? - 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: - 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? -
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - 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? -
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? - answer 1. Medical, pharmacy, dental, and nursing students
4. Serving military personnel
T or F: The terms "serious" and "severe" are synonymous according to ICH -answer False
An Unexpected Adverse drug reaction is: - answer A reaction that is not consistent with the applicable
ICH safety definitions can be found in - answer ICH E2A
An Adverse Event (AE) that is severe in intensity - 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. - 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: - 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. - 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: - 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: - answer A serious adverse
After a Serious Adverse Event (SAE) has occurred, how should you list the subject identification on the
immediate and follow-up reports? - answer By their subject identification number
In which scenario would unblinding typically occur? - answer When the investigator wants to make sure a
particular subject is not randomized to placebo in the case of a Serious Adverse Event (SAE) [Show Less]