ACRP CCRC EXAM PREP Exam Study Guide
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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 more
possible consequences of sites may be needed
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 immediate - Regulatory Authorities
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 enrolling - Subject has given written informed consent
a subject into your trial?
You've been delegated to - Contact the Sponsor, explain what happened and
handle the storage and ask for instructions
inventory of IP. The study - Set up a site staff meeting to conduct a root cause
drug must be stored analysis
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 the
site received IRB approval protocol.
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 You ask if the patient wishes to share the reason why
she no longer wants to she wants to leave the trial. If not, you exclude the
participant in the trial. subject from the trial immediately.
What should your course
of action be?
Questions with Correct Answers 2025 latest
update!!
Save
Terms in this set (298)
- The trial will overrun its projected timeline
What are expected or - The recruitment period will be prolonged and more
possible consequences of sites may be needed
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 immediate - Regulatory Authorities
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 enrolling - Subject has given written informed consent
a subject into your trial?
You've been delegated to - Contact the Sponsor, explain what happened and
handle the storage and ask for instructions
inventory of IP. The study - Set up a site staff meeting to conduct a root cause
drug must be stored analysis
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 the
site received IRB approval protocol.
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 You ask if the patient wishes to share the reason why
she no longer wants to she wants to leave the trial. If not, you exclude the
participant in the trial. subject from the trial immediately.
What should your course
of action be?
