ACRP-CP Certification Exam with Correct
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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 Validation
from paper CRF to an Accuracy
EDC system. The EDC Reliability
system must conform to Completeness
the established
requirements for
Part of a sponsor's maintain an audit trail, data trail, and edit trail.
responsibility 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 The CRA
study: whose
responsibility is it to report
subject recruitment rate?
An unconscious adult Obtain consent from the subject for the study
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
A site is in the start up A signed clinical trial agreement between the site and
phase of an industry sponsor is in place.
sponsored phase 3 trial:
and has received IRB
approval. The site can
begin enrolling subjects
after...
, A site is screening A research assistant who is certified to administer the
potential subjects for a psychometric test
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 Wording indicating that there is no expected benefit
there is no intended should be included
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 Confirm dates of initial receipt of the sponsor
onsite visit that the date protocol and the IRB submission dates.
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?
Answers
Save
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 Validation
from paper CRF to an Accuracy
EDC system. The EDC Reliability
system must conform to Completeness
the established
requirements for
Part of a sponsor's maintain an audit trail, data trail, and edit trail.
responsibility 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 The CRA
study: whose
responsibility is it to report
subject recruitment rate?
An unconscious adult Obtain consent from the subject for the study
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
A site is in the start up A signed clinical trial agreement between the site and
phase of an industry sponsor is in place.
sponsored phase 3 trial:
and has received IRB
approval. The site can
begin enrolling subjects
after...
, A site is screening A research assistant who is certified to administer the
potential subjects for a psychometric test
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 Wording indicating that there is no expected benefit
there is no intended should be included
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 Confirm dates of initial receipt of the sponsor
onsite visit that the date protocol and the IRB submission dates.
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?
