ACRP-CP CERTIFICATION EXAM QUESTIONS |
GUARANTEED ACCURATE ANSWERS |VERIFIED |
COMPLETE!!
Terms in this set (216)
What would be the first priority Try to obtain the subject's reason for withdrawal.
for an investigator when a
subject wishes to withdraw
prematurely from the trial?
CRO recently switched from Validation
paper CRF to an EDC system. Accurac
The EDC system must conform y
to the established requirements Reliability
for 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 Obtain consent from the subject for the study
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 phase A signed clinical trial agreement between the site and sponsor is
of an industry sponsored in place.
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
subjects for a study looking psychometric test
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 should be
there is no intended clinical included
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
visit that the date on IRB 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
GUARANTEED ACCURATE ANSWERS |VERIFIED |
COMPLETE!!
Terms in this set (216)
What would be the first priority Try to obtain the subject's reason for withdrawal.
for an investigator when a
subject wishes to withdraw
prematurely from the trial?
CRO recently switched from Validation
paper CRF to an EDC system. Accurac
The EDC system must conform y
to the established requirements Reliability
for 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 Obtain consent from the subject for the study
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 phase A signed clinical trial agreement between the site and sponsor is
of an industry sponsored in place.
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
subjects for a study looking psychometric test
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 should be
there is no intended clinical included
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
visit that the date on IRB 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
