ACRP CP CERTIFICATION EXAM 2024
ACTUAL EXAM COMPLETE ACCURATE
EXAM QUESTIONS WITH DETAILED
VERIFIED ANSWERS (100% CORRECT
ANSWERS
What would be the first priority for an
investigator when a subject wishes to
withdraw prematurely from the trial? -
answersTry 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
- answersValidation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining
to electronic trial data handling is to -
,answersmaintain an audit trail, data trail,
and edit trail.
A research subject's responsibilities for
study participation should be described in
the - answersICF
What document would an investigator
reference to learn more about the previous
clinical and nonclinical results of studies of
the IP? - answersInvestigators brochure
During a multi site clinical study: whose
responsibility is it to report subject
recruitment rate? - answersThe CRA
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 - answersObtain 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 after... - answersA signed clinical
trial agreement between the site and
sponsor is in place.
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? - answersA 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. What benefit
information should be included in the ICF? -
answersWording indicating that there is no
expected benefit should be included
A CRA notices during an onsite visit that
the date on IRB 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? -
answersConfirm dates of initial receipt of
the sponsor protocol and the IRB
submission dates.
In a multi 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 written
report to the IRB? - answersPI
Which of the following required elements
should be included in a clinical trial
protocol? - answersSubject inclusion and
exclusion criteria
Prior to archiving a study: documentation of
IP destruction at the site should be filed in
the study files of the - answersPI and
Sponsor
During a monitoring visit: what records
would a CRA reference to verify a subject's
compliance to the study visit schedule and
ACTUAL EXAM COMPLETE ACCURATE
EXAM QUESTIONS WITH DETAILED
VERIFIED ANSWERS (100% CORRECT
ANSWERS
What would be the first priority for an
investigator when a subject wishes to
withdraw prematurely from the trial? -
answersTry 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
- answersValidation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining
to electronic trial data handling is to -
,answersmaintain an audit trail, data trail,
and edit trail.
A research subject's responsibilities for
study participation should be described in
the - answersICF
What document would an investigator
reference to learn more about the previous
clinical and nonclinical results of studies of
the IP? - answersInvestigators brochure
During a multi site clinical study: whose
responsibility is it to report subject
recruitment rate? - answersThe CRA
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 - answersObtain 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 after... - answersA signed clinical
trial agreement between the site and
sponsor is in place.
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? - answersA 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. What benefit
information should be included in the ICF? -
answersWording indicating that there is no
expected benefit should be included
A CRA notices during an onsite visit that
the date on IRB 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? -
answersConfirm dates of initial receipt of
the sponsor protocol and the IRB
submission dates.
In a multi 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 written
report to the IRB? - answersPI
Which of the following required elements
should be included in a clinical trial
protocol? - answersSubject inclusion and
exclusion criteria
Prior to archiving a study: documentation of
IP destruction at the site should be filed in
the study files of the - answersPI and
Sponsor
During a monitoring visit: what records
would a CRA reference to verify a subject's
compliance to the study visit schedule and
