ACRP CCRA EXAM PREP STUDY GUIDE Exam |
Questions with 100% Correct Answers | Verified |
Latest Update 2026/2027
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Terms in this set (298)
What are expected or possible - The trial will overrun its projected timeline
consequences of over-estimation of - The recruitment period will be prolonged and
recruitment potential? more sites may be needed
- The study will not have sufficient data within the
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 allowed to When there is an immediate hazard to a patient.
deviate from the protocol?
If the investigator wanted to deviate - The Sponsor
from the protocol for an immediate - IRB/IEC
hazard to a patient, according to ICH - Regulatory Authorities
E6 guidelines who world they need
to report the deviation and rationale
to, if appropriate?
,Which conditions should be fulfilled - Subject meets all inclusion criteria
when enrolling a subject into your - Subject has given written informed consent
trial?
You've been delegated to handle the - Contact the Sponsor, explain what happened and
storage and inventory of IP. The ask for instructions
study drug must be stored below - Set up a site staff meeting to conduct a root
25C/77F. On a summer Monday cause analysis
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 was issued No, these subjects are still enrolled in the trial and
for a trial. Your site received IRB therefore need to be updated on any changes to
approval for the amendment and the protocol.
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 she no You ask if the patient wishes to share the reason
longer wants to participant in the why she wants to leave the trial. If not, you exclude
trial. What should your course of the subject from the trial immediately.
action be?
A patient cannot recall the name of You attempt to retrieve the patients medical history
the heart condition medication he by contacting previous caregivers and you wait for
took a few years ago. This is additional information before enrollment.
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 responsibility The principle investigator.
for each subject?
A trial subject suffers from severe No
repeat headaches. Should this
adverse event be reported to the
IRB?
What statements are true concerning - All noxious and unintended responses to a
an adverse drug reaction? medicinal product related to any dose should be
considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events (AEs) are - Any AE that results in death
Serious Adverse Events (SAEs)? - Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
Questions with 100% Correct Answers | Verified |
Latest Update 2026/2027
Save
Terms in this set (298)
What are expected or possible - The trial will overrun its projected timeline
consequences of over-estimation of - The recruitment period will be prolonged and
recruitment potential? more sites may be needed
- The study will not have sufficient data within the
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 allowed to When there is an immediate hazard to a patient.
deviate from the protocol?
If the investigator wanted to deviate - The Sponsor
from the protocol for an immediate - IRB/IEC
hazard to a patient, according to ICH - Regulatory Authorities
E6 guidelines who world they need
to report the deviation and rationale
to, if appropriate?
,Which conditions should be fulfilled - Subject meets all inclusion criteria
when enrolling a subject into your - Subject has given written informed consent
trial?
You've been delegated to handle the - Contact the Sponsor, explain what happened and
storage and inventory of IP. The ask for instructions
study drug must be stored below - Set up a site staff meeting to conduct a root
25C/77F. On a summer Monday cause analysis
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 was issued No, these subjects are still enrolled in the trial and
for a trial. Your site received IRB therefore need to be updated on any changes to
approval for the amendment and the protocol.
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 she no You ask if the patient wishes to share the reason
longer wants to participant in the why she wants to leave the trial. If not, you exclude
trial. What should your course of the subject from the trial immediately.
action be?
A patient cannot recall the name of You attempt to retrieve the patients medical history
the heart condition medication he by contacting previous caregivers and you wait for
took a few years ago. This is additional information before enrollment.
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 responsibility The principle investigator.
for each subject?
A trial subject suffers from severe No
repeat headaches. Should this
adverse event be reported to the
IRB?
What statements are true concerning - All noxious and unintended responses to a
an adverse drug reaction? medicinal product related to any dose should be
considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
What Adverse Events (AEs) are - Any AE that results in death
Serious Adverse Events (SAEs)? - Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
