Exam (elaborations)
ACRP-CP CERTIFICATION EXAM (LATEST UPDATE 2024/2025) VERIFIED SOLUTIONS 100%
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QUESTIONS AND ANSWERS
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ACRP-CP CERTIFICATIONEXAM (LATESTST UPDATE
2024/2025) VERIFIED
SOLUTIONS 100%
What would be the first priority for an inves6gator when a subject wishes to
withdraw prematurely from the trial?
Try to obtain the subject's reason for withdrawal.
Cro recently switched from paper crf to an edc system. The edc system must
conform to the established requirements for
Valida6on
accuracy
reliability
completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is
to
Maintain an audit trail, data trail, and edit trail.
A research subject's responsibili6es for study par6cipa6on should be described
in the
Icf
What document would an inves6gator reference to learn more about the
previous clinical and nonclinical results of studies of the ip?
Inves6gators brochure
During a mul6 site clinical study: whose responsibility is it to report subject
recruitment rate?
,The cra
An unconscious adult subject was enrolled in a study aIer obtaining consent
from an lar: and protocol therapy was ini6ated. The subject showed significant
improvement in his clinical condi6on: and regained consciousness. The
inves6gator should inform the subject about the study and
Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has
received irb approval. The site can begin enrolling subjects aIer...
A signed clinical trial agreement between the site and sponsor is in place.
A site is screening poten6al subjects for a study looking at mild cogni6ve
impairment. One of the inclusion criteria is a score of 25 or less on a
psychometric test: a research specific tool which measures cogni6ve ability.
Which of the following individuals can administer the psychometric test to the
poten6al subjects?
A research assistant who is cer6fied to administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is
being submiOed to the irb. What benefit informa6on should be included in the
icf?
Wording indica6ng that there is no expected benefit should be included
A cra no6ces during an onsite visit that the date on irb approval leOer for a
protocol is prior to the effec6ve date indicated on the cover page of the
protocol and the signatures of the inves6gator and sponsor. What should the
cra do first?
Confirm dates of ini6al receipt of the sponsor protocol and the irb submission
dates.
, In a mul6 arm: randomized clinical trial: one arm of the protocol was
terminated due to an increased risk of cancer in subjects. Who is responsible
for providing a wriOen report to the irb?
Pi
Which of the following required elements should be included in a clinical trial
protocol?
Subject inclusion and exclusion criteria
Prior to archiving a study: documenta6on of ip destruc6on at the site should be
filed in the study files of the
Pi and sponsor
During a monitoring visit: what records would a cra reference to verify a
subject's compliance to the study visit schedule and assessments?
Electronic medical record
When considering par6cipa6on in a study: the inves6gator should determine if
he...
Sees enough pa6ents who would qualify for the study
New safety informa6on has become available from the sponsor about the ip
being used in a clinical trial. The inves6gator must
Submit a revised icf to the irb no6ng the new safety informa6on
Per ich: an irb must keep correspondence for at least how long aIer the
comple6on of a clinical trial?
3 years
When would an impar6al witness be needed during the consent process for an
illiterate subject?
To observe the consent process
A study which seeks to determine the ideal dose and regimen of a new ip to
treat hypothyroidism is considered to be
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