ACRP-CP CERTIFICATION EXAM 2024-
2025 NEWEST ACTUAL EXAM
QUESTIONS AND DETAILED CORRECT
ANSWERS | A+ GRADE
A medical student is approaches by a faculty member for
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to
the study? Correct Answer Consenting in the presence of
figure of authority
The clinical trial phase that focuses on safety and human
pharmacology in healthy volunteers Correct Answer
Phase I
Who is ultimately responsible for all aspects of the
research conducted at a site? Correct Answer Principal
investigator
An international quality standard that is provided by ICH
E6(R2) describing safety: accuracy of trials and credibility
of data Correct Answer GCP
What event resulted in the Nuremburg Cod of 1949
Correct Answer Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction
at the site should be filed in the study files of the Correct
Answer PI and Sponsor
,In the case of an incapacitated subject: who should
receive a copy of the signed and dated ICF? Correct
Answer The subject's legally acceptable representative
Which of the following required elements should be
included in a clinical trial protocol? Correct Answer The
subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it
to report subject recruitment rate? Correct Answer The
CRA
A study which seeks to determine the ideal dose and
regimen of a new IP to treat hypothyroidism is considered
to be Correct Answer Phase II
What document would an investigator reference to learn
more about the previous clinical and nonclinical results of
studies of the IP? Correct Answer IB
When considering participation in a study: the investigator
should determine if he/she Correct 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? Correct 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? Correct 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? Correct 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?
Correct 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 Correct Answer ICF
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.
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