ACRP PRACTICE EXAM 2024- 2025
QUESTIONS AND ANSWERS/ ACRP
PRACTICE EXAM WITH COMPLETE
QUESTIONS AND CORRECT ANSWERS
RATED A+
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
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 sponsors files
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
When should a research study involving human subjects be
registered in a publicly accessible database? Correct Answer
Before recruiting the first subject
In the case of an incapacitated subject: who should receive a
copy of the signed and dated ICF? Correct Answer The subjects
legally acceptable representative
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.
When should a research study involving human subjects be
registered in a publicly accessible database? Correct Answer
Before recruiting the first subject
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