ACRP CP CERTIFICATION EXAM 2024
Study online at https://quizlet.com/_hlzsup
What would be the first priority for an
Try to obtain the subject's reason for with-
investigator when a subject wishes to
drawal.
withdraw prematurely from the trial?
CRO recently switched from paper CRF Validation
to an EDC system. The EDC system Accuracy
must conform to the established require- Reliability
ments for Completeness
Part of a sponsor's responsibility pertain- maintain an audit trail, data trail, and edit
ing to electronic trial data handling is to trail.
A research subject's responsibilities for
study participation should be described ICF
in the
What document would an investigator
reference to learn more about the pre-
Investigators brochure
vious clinical and nonclinical results of
studies of the IP?
During a multi site clinical study: whose
responsibility is it to report subject re- The CRA
cruitment rate?
An unconscious adult subject was en-
rolled in a study after obtaining consent
from an LAR: and protocol therapy was
initiated. The subject showed significant Obtain consent from the subject for the
improvement in his clinical condition: and study
regained consciousness. The Investiga-
tor should inform the subject about the
study and
A site is in the start up phase of an indus-
try sponsored phase 3 trial: and has re- A signed clinical trial agreement between
ceived IRB approval. The site can begin the site and sponsor is in place.
enrolling subjects after...
A site is screening potential subjects for
a study looking at mild cognitive impair-
ment. One of the inclusion criteria is a
score of 25 or less on a psychomet-
ric test: a research specific tool which
, ACRP CP CERTIFICATION EXAM 2024
Study online at https://quizlet.com/_hlzsup
measures cognitive ability. Which of the
following individuals can administer the A research assistant who is certified to
psychometric test to the potential sub- administer the psychometric test
jects?
A research study: in which there is no
intended clinical benefit to the subject: is
Wording indicating that there is no ex-
being submitted to the IRB. What bene-
pected benefit should be included
fit information should be included in the
ICF?
A CRA notices during an onsite visit that
the date on IRB approval letter for a pro-
tocol is prior to the effective date indi- Confirm dates of initial receipt of the
cated on the cover page of the proto- sponsor protocol and the IRB submis-
col and the signatures of the investigator sion dates.
and sponsor. What should the CRA do
FIRST?
In a multi arm: randomized clinical trial:
one arm of the protocol was terminated
due to an increased risk of cancer in sub- PI
jects. Who is responsible for providing a
written report to the IRB?
Which of the following required elements
should be included in a clinical trial pro- Subject inclusion and exclusion criteria
tocol?
Prior to archiving a study: documentation
of IP destruction at the site should be PI and Sponsor
filed in the study files of the
During a monitoring visit: what records
would a CRA reference to verify a
Electronic medical record
subject's compliance to the study visit
schedule and assessments?
When considering participation in a
Sees enough patients who would qualify
study: the investigator should determine
for the study
if he...
New safety information has become
available from the Sponsor about the IP
, ACRP CP CERTIFICATION EXAM 2024
Study online at https://quizlet.com/_hlzsup
being used in a clinical trial. The investi- Submit a revised ICF to the IRB noting
gator must the new safety information
Per ICH: an IRB must keep correspon-
dence for at least how long after the com- 3 Years
pletion of a clinical trial?
When would an impartial witness be
needed during the consent process for To observe the consent process
an illiterate subject?
A study which seeks to determine the
ideal dose and regimen of a new IP to Phase II
treat hypothyroidism is considered to be
After completion of a study: the final trial
close out monitoring report prepared by
The sponsors files
the CRA should be filed in which of the
following stakeholder files?
A blood sample collection is required
to screen for bloodborne pathogens be-
fore subject could be enrolled in a study.
ICF
Where will subjects find information of
the procedures and any foreseeable
risks or inconveniences?
When should a research study involving
human subjects be registered in a pub- Before recruiting the first subject
licly accessible database?
In the case of an incapacitated subject:
The subjects legally acceptable repre-
who should receive a copy of the signed
sentative
and dated ICF?
A medical student is approaches by a
faculty member for possible participa-
Consenting in the presence of figure of
tion in a cricothyroidotomy simulation re-
authority
search study. Which of the following in-
creases risk to the study?
The clinical trial phase that focuses
on safety and human pharmacology in Phase I
healthy volunteers
Study online at https://quizlet.com/_hlzsup
What would be the first priority for an
Try to obtain the subject's reason for with-
investigator when a subject wishes to
drawal.
withdraw prematurely from the trial?
CRO recently switched from paper CRF Validation
to an EDC system. The EDC system Accuracy
must conform to the established require- Reliability
ments for Completeness
Part of a sponsor's responsibility pertain- maintain an audit trail, data trail, and edit
ing to electronic trial data handling is to trail.
A research subject's responsibilities for
study participation should be described ICF
in the
What document would an investigator
reference to learn more about the pre-
Investigators brochure
vious clinical and nonclinical results of
studies of the IP?
During a multi site clinical study: whose
responsibility is it to report subject re- The CRA
cruitment rate?
An unconscious adult subject was en-
rolled in a study after obtaining consent
from an LAR: and protocol therapy was
initiated. The subject showed significant Obtain consent from the subject for the
improvement in his clinical condition: and study
regained consciousness. The Investiga-
tor should inform the subject about the
study and
A site is in the start up phase of an indus-
try sponsored phase 3 trial: and has re- A signed clinical trial agreement between
ceived IRB approval. The site can begin the site and sponsor is in place.
enrolling subjects after...
A site is screening potential subjects for
a study looking at mild cognitive impair-
ment. One of the inclusion criteria is a
score of 25 or less on a psychomet-
ric test: a research specific tool which
, ACRP CP CERTIFICATION EXAM 2024
Study online at https://quizlet.com/_hlzsup
measures cognitive ability. Which of the
following individuals can administer the A research assistant who is certified to
psychometric test to the potential sub- administer the psychometric test
jects?
A research study: in which there is no
intended clinical benefit to the subject: is
Wording indicating that there is no ex-
being submitted to the IRB. What bene-
pected benefit should be included
fit information should be included in the
ICF?
A CRA notices during an onsite visit that
the date on IRB approval letter for a pro-
tocol is prior to the effective date indi- Confirm dates of initial receipt of the
cated on the cover page of the proto- sponsor protocol and the IRB submis-
col and the signatures of the investigator sion dates.
and sponsor. What should the CRA do
FIRST?
In a multi arm: randomized clinical trial:
one arm of the protocol was terminated
due to an increased risk of cancer in sub- PI
jects. Who is responsible for providing a
written report to the IRB?
Which of the following required elements
should be included in a clinical trial pro- Subject inclusion and exclusion criteria
tocol?
Prior to archiving a study: documentation
of IP destruction at the site should be PI and Sponsor
filed in the study files of the
During a monitoring visit: what records
would a CRA reference to verify a
Electronic medical record
subject's compliance to the study visit
schedule and assessments?
When considering participation in a
Sees enough patients who would qualify
study: the investigator should determine
for the study
if he...
New safety information has become
available from the Sponsor about the IP
, ACRP CP CERTIFICATION EXAM 2024
Study online at https://quizlet.com/_hlzsup
being used in a clinical trial. The investi- Submit a revised ICF to the IRB noting
gator must the new safety information
Per ICH: an IRB must keep correspon-
dence for at least how long after the com- 3 Years
pletion of a clinical trial?
When would an impartial witness be
needed during the consent process for To observe the consent process
an illiterate subject?
A study which seeks to determine the
ideal dose and regimen of a new IP to Phase II
treat hypothyroidism is considered to be
After completion of a study: the final trial
close out monitoring report prepared by
The sponsors files
the CRA should be filed in which of the
following stakeholder files?
A blood sample collection is required
to screen for bloodborne pathogens be-
fore subject could be enrolled in a study.
ICF
Where will subjects find information of
the procedures and any foreseeable
risks or inconveniences?
When should a research study involving
human subjects be registered in a pub- Before recruiting the first subject
licly accessible database?
In the case of an incapacitated subject:
The subjects legally acceptable repre-
who should receive a copy of the signed
sentative
and dated ICF?
A medical student is approaches by a
faculty member for possible participa-
Consenting in the presence of figure of
tion in a cricothyroidotomy simulation re-
authority
search study. Which of the following in-
creases risk to the study?
The clinical trial phase that focuses
on safety and human pharmacology in Phase I
healthy volunteers
