ACRP CP CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE ACCURATE
EXAM QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS
Terms in this set (216)
What would be the first Try to obtain the subject's reason for withdrawal.
priority for an investigator
when a subject wishes to
withdraw prematurely from
the trial?
CRO recently switched from Validati
paper CRF to an EDC system. on
The EDC system must conform Accurac
to the established requirements y
for Reliabil
ity
Completeness
Part of a sponsor's responsibility maintain an audit trail, data trail, and edit trail.
pertaining to electronic trial
data handling is to
A research subject's ICF
responsibilities for study
participation should be described
in the
What document would an Investigators brochure
investigator
reference to learn more about
the previous clinical and
nonclinical results of studies of
the IP?
During a multi site clinical study: The CRA
whose responsibility is it to
report subject
recruitment rate?
,An unconscious adult subject was Obtain consent from the subject for the study
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
A site is in the start up phase of A signed clinical trial agreement between the site and sponsor is in place.
an industry sponsored phase 3
trial: and has received IRB
approval. The site can begin
enrolling subjects after...
A site is screening potential A research assistant who is certified to administer the psychometric test
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?
A research study: in which there is Wording indicating that there is no expected benefit should be included
no
intended clinical benefit to the
subject: is being submitted to
the IRB. What benefit
information should be included
in the ICF?
, A CRA notices during an onsite Confirm dates of initial receipt of the sponsor protocol and the IRB
visit that the date on IRB submission dates.
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?
In a multi arm: randomized PI
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?
Which of the following required Subject inclusion and exclusion criteria
elements should be included in
a clinical trial
protocol?
Prior to archiving a study: PI and Sponsor
documentation of IP destruction
at the site should be filed in the
study files of the
During a monitoring visit: what Electronic medical record
records
would a CRA reference to verify a
subject's compliance to the study
visit schedule and assessments?
When considering participation Sees enough patients who would qualify for the study
in a study: the investigator
should determine if he...
New safety information has Submit a revised ICF to the IRB noting the new safety information
become available from the
Sponsor about the IP being used
in a clinical trial. The
investigator must
EXAM QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS
Terms in this set (216)
What would be the first Try to obtain the subject's reason for withdrawal.
priority for an investigator
when a subject wishes to
withdraw prematurely from
the trial?
CRO recently switched from Validati
paper CRF to an EDC system. on
The EDC system must conform Accurac
to the established requirements y
for Reliabil
ity
Completeness
Part of a sponsor's responsibility maintain an audit trail, data trail, and edit trail.
pertaining to electronic trial
data handling is to
A research subject's ICF
responsibilities for study
participation should be described
in the
What document would an Investigators brochure
investigator
reference to learn more about
the previous clinical and
nonclinical results of studies of
the IP?
During a multi site clinical study: The CRA
whose responsibility is it to
report subject
recruitment rate?
,An unconscious adult subject was Obtain consent from the subject for the study
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
A site is in the start up phase of A signed clinical trial agreement between the site and sponsor is in place.
an industry sponsored phase 3
trial: and has received IRB
approval. The site can begin
enrolling subjects after...
A site is screening potential A research assistant who is certified to administer the psychometric test
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?
A research study: in which there is Wording indicating that there is no expected benefit should be included
no
intended clinical benefit to the
subject: is being submitted to
the IRB. What benefit
information should be included
in the ICF?
, A CRA notices during an onsite Confirm dates of initial receipt of the sponsor protocol and the IRB
visit that the date on IRB submission dates.
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?
In a multi arm: randomized PI
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?
Which of the following required Subject inclusion and exclusion criteria
elements should be included in
a clinical trial
protocol?
Prior to archiving a study: PI and Sponsor
documentation of IP destruction
at the site should be filed in the
study files of the
During a monitoring visit: what Electronic medical record
records
would a CRA reference to verify a
subject's compliance to the study
visit schedule and assessments?
When considering participation Sees enough patients who would qualify for the study
in a study: the investigator
should determine if he...
New safety information has Submit a revised ICF to the IRB noting the new safety information
become available from the
Sponsor about the IP being used
in a clinical trial. The
investigator must
