ACRP CCRC Exam Prep - Questions With
Complete Solutions
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Terms in this set (298)
- The trial will overrun its projected timeline
What are expected or - The recruitment period will be prolonged and
possible consequences more sites may be needed
of over-estimation of - The study will not have sufficient data within the
recruitment potential? required timeframe and will be stopped because of
lack of budget
What should be the first Subject welfare
consideration when
conducting a clinical
trial?
When is the investigator When there is an immediate hazard to a patient.
allowed to deviate from
the protocol?
If the investigator wanted - The Sponsor
to deviate from the - IRB/IEC
protocol for an - Regulatory Authorities
immediate hazard to a
patient, according to ICH
E6 guidelines who world
they need to report the
deviation and rationale
to, if appropriate?
Which conditions should - Subject meets all inclusion criteria
be fulfilled when - Subject has given written informed consent
enrolling a subject into
your trial?
,You've been delegated - Contact the Sponsor, explain what happened and
to handle the storage ask for instructions
and inventory of IP. The - Set up a site staff meeting to conduct a root cause
study drug must be analysis
stored below 25C/77F.
On a summer Monday
morning you discover
that the temperature
recording machine in the
storage room has failed
so you doin't know what
the temperature has
been over the weekend.
You check the current
temperature; it's 24C/75F.
What should you do?
,A protocol amendment No, these subjects are still enrolled in the trial and
was issued for a trial. Your therefore need to be updated on any changes to
site received IRB the protocol.
approval for the
amendment and wants to
implement the increase in
PO dose for your trial
subjects as identified in
the amendment trial
subjects. As delegated
consenting duties you
must re-consent trial
subjects before being
able to administer the
adjusted dose. You
decide to only re-
consent trial subjects
who are still taking the IP
and not from the subjects
woh already completed
their drug intake period.
Is this allowed according
the E6 Guideline for
GCP?
A trial subject informs You ask if the patient wishes to share the reason why
you she no longer wants she wants to leave the trial. If not, you exclude the
to participant in the trial. subject from the trial immediately.
What should your course
of action be?
, A patient cannot recall You attempt to retrieve the patients medical history
the name of the heart by contacting previous caregivers and you wait for
condition medication he additional information before enrollment.
took a few years ago. This
is important information
for deciding whether the
patient may be enrolled
in a clinical trial (IC/EC).
What's your best course
of action?
Who has ultimate trial The principle investigator.
responsibility for each
subject?
A trial subject suffers No
from severe repeat
headaches. Should this
adverse event be
reported to the IRB?
- All noxious and unintended responses to a
What statements are true medicinal product related to any dose should be
concerning an adverse considered as an ADR
drug reaction? - An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events - Any AE that results in death
(AEs) are Serious - Any AE that results in inpatient hospitalization
Adverse Events (SAEs)? - Any AE that is a congenital anomaly
Complete Solutions
Save
Terms in this set (298)
- The trial will overrun its projected timeline
What are expected or - The recruitment period will be prolonged and
possible consequences more sites may be needed
of over-estimation of - The study will not have sufficient data within the
recruitment potential? required timeframe and will be stopped because of
lack of budget
What should be the first Subject welfare
consideration when
conducting a clinical
trial?
When is the investigator When there is an immediate hazard to a patient.
allowed to deviate from
the protocol?
If the investigator wanted - The Sponsor
to deviate from the - IRB/IEC
protocol for an - Regulatory Authorities
immediate hazard to a
patient, according to ICH
E6 guidelines who world
they need to report the
deviation and rationale
to, if appropriate?
Which conditions should - Subject meets all inclusion criteria
be fulfilled when - Subject has given written informed consent
enrolling a subject into
your trial?
,You've been delegated - Contact the Sponsor, explain what happened and
to handle the storage ask for instructions
and inventory of IP. The - Set up a site staff meeting to conduct a root cause
study drug must be analysis
stored below 25C/77F.
On a summer Monday
morning you discover
that the temperature
recording machine in the
storage room has failed
so you doin't know what
the temperature has
been over the weekend.
You check the current
temperature; it's 24C/75F.
What should you do?
,A protocol amendment No, these subjects are still enrolled in the trial and
was issued for a trial. Your therefore need to be updated on any changes to
site received IRB the protocol.
approval for the
amendment and wants to
implement the increase in
PO dose for your trial
subjects as identified in
the amendment trial
subjects. As delegated
consenting duties you
must re-consent trial
subjects before being
able to administer the
adjusted dose. You
decide to only re-
consent trial subjects
who are still taking the IP
and not from the subjects
woh already completed
their drug intake period.
Is this allowed according
the E6 Guideline for
GCP?
A trial subject informs You ask if the patient wishes to share the reason why
you she no longer wants she wants to leave the trial. If not, you exclude the
to participant in the trial. subject from the trial immediately.
What should your course
of action be?
, A patient cannot recall You attempt to retrieve the patients medical history
the name of the heart by contacting previous caregivers and you wait for
condition medication he additional information before enrollment.
took a few years ago. This
is important information
for deciding whether the
patient may be enrolled
in a clinical trial (IC/EC).
What's your best course
of action?
Who has ultimate trial The principle investigator.
responsibility for each
subject?
A trial subject suffers No
from severe repeat
headaches. Should this
adverse event be
reported to the IRB?
- All noxious and unintended responses to a
What statements are true medicinal product related to any dose should be
concerning an adverse considered as an ADR
drug reaction? - An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events - Any AE that results in death
(AEs) are Serious - Any AE that results in inpatient hospitalization
Adverse Events (SAEs)? - Any AE that is a congenital anomaly
