ACRP CCRA EXAM 2026 FULL PRACTICE
QUESTIONS AND ANSWERS
◉ What should be the first consideration when conducting a clinical
trial? Answer: Subject welfare
◉ When is the investigator allowed to deviate from the protocol?
Answer: When there is an immediate hazard to a patient.
◉ If the investigator wanted to deviate from the protocol for an
immediate hazard to a patient, according to ICH E6 guidelines who
world they need to report the deviation and rationale to, if
appropriate? Answer: - The Sponsor
- IRB/IEC
- Regulatory Authorities
◉ Which conditions should be fulfilled when enrolling a subject into
your trial? Answer: - Subject meets all inclusion criteria
- Subject has given written informed consent
◉ You've been delegated to handle the storage and inventory of IP.
The study drug must be 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? Answer: - Contact
the Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
◉ A protocol amendment was issued for a trial. Your site received
IRB 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? Answer: No, these subjects are still enrolled in the trial and
therefore need to be updated on any changes to the protocol.
◉ A trial subject informs you she no longer wants to participant in
the trial. What should your course of action be? Answer: You ask if
the patient wishes to share the reason why she wants to leave the
trial. If not, you exclude the subject from the trial immediately.
◉ A patient cannot recall the name of the heart condition
medication he 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? Answer: You attempt to
retrieve the patients medical history by contacting previous
,caregivers and you wait for additional information before
enrollment.
◉ Who has ultimate trial responsibility for each subject? Answer:
The principle investigator.
◉ A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB? Answer: No
◉ What statements are true concerning an adverse drug reaction?
Answer: - All noxious and unintended responses to a 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 Serious Adverse Events (SAEs)?
Answer: - Any AE that results in death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
◉ During a study visit a patient tells the investigator that she visited
an emergency room and received intensive treatment for allergic
bronchospasm. Since the patient was in the emergency room for
only three hours, the investigator did not assess the event as serious.
, Is this a correct assessment? Answer: No, this would be a medically
important event and should be considered serious
◉ What data points minimally need to be reported by the site when
reporting an SAE, so that the sponsor can process the event?
Answer: Identification of event, product, and trial subject
◉ During a visit with investigator, a subject reported feeling heart
palpitations for a brief period of time during the previous evening.
The heart palpitations resolved without reoccurrence. The
investigator considered these symptoms to be unrelated to study
drug. The next day, the subject told a fellow student that he felt tired
and was planning on taking a nap. Later, the subject was found dead.
A preliminary report from the medical examiner indicated the
subject died of pulmonary embolism. What should your next course
of action be? Answer: - Record these events in case report form
- Immediately notify sponsor about serious adverse events
◉ When asked by a regulatory body why they received SAE related
information on 12/2013 from an incident that occurred in 5/2013,
the sponsor explained the reason being they received the trial
related SAE information from the investigator in 12/2013. Is the
sponsor correct in only holding the investigator accountable for
their late reporting? Answer: No, the sponsor should support the
conduct QC activities with the sites to help them ensure timely SAE
reporting.
QUESTIONS AND ANSWERS
◉ What should be the first consideration when conducting a clinical
trial? Answer: Subject welfare
◉ When is the investigator allowed to deviate from the protocol?
Answer: When there is an immediate hazard to a patient.
◉ If the investigator wanted to deviate from the protocol for an
immediate hazard to a patient, according to ICH E6 guidelines who
world they need to report the deviation and rationale to, if
appropriate? Answer: - The Sponsor
- IRB/IEC
- Regulatory Authorities
◉ Which conditions should be fulfilled when enrolling a subject into
your trial? Answer: - Subject meets all inclusion criteria
- Subject has given written informed consent
◉ You've been delegated to handle the storage and inventory of IP.
The study drug must be 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? Answer: - Contact
the Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
◉ A protocol amendment was issued for a trial. Your site received
IRB 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? Answer: No, these subjects are still enrolled in the trial and
therefore need to be updated on any changes to the protocol.
◉ A trial subject informs you she no longer wants to participant in
the trial. What should your course of action be? Answer: You ask if
the patient wishes to share the reason why she wants to leave the
trial. If not, you exclude the subject from the trial immediately.
◉ A patient cannot recall the name of the heart condition
medication he 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? Answer: You attempt to
retrieve the patients medical history by contacting previous
,caregivers and you wait for additional information before
enrollment.
◉ Who has ultimate trial responsibility for each subject? Answer:
The principle investigator.
◉ A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB? Answer: No
◉ What statements are true concerning an adverse drug reaction?
Answer: - All noxious and unintended responses to a 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 Serious Adverse Events (SAEs)?
Answer: - Any AE that results in death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
◉ During a study visit a patient tells the investigator that she visited
an emergency room and received intensive treatment for allergic
bronchospasm. Since the patient was in the emergency room for
only three hours, the investigator did not assess the event as serious.
, Is this a correct assessment? Answer: No, this would be a medically
important event and should be considered serious
◉ What data points minimally need to be reported by the site when
reporting an SAE, so that the sponsor can process the event?
Answer: Identification of event, product, and trial subject
◉ During a visit with investigator, a subject reported feeling heart
palpitations for a brief period of time during the previous evening.
The heart palpitations resolved without reoccurrence. The
investigator considered these symptoms to be unrelated to study
drug. The next day, the subject told a fellow student that he felt tired
and was planning on taking a nap. Later, the subject was found dead.
A preliminary report from the medical examiner indicated the
subject died of pulmonary embolism. What should your next course
of action be? Answer: - Record these events in case report form
- Immediately notify sponsor about serious adverse events
◉ When asked by a regulatory body why they received SAE related
information on 12/2013 from an incident that occurred in 5/2013,
the sponsor explained the reason being they received the trial
related SAE information from the investigator in 12/2013. Is the
sponsor correct in only holding the investigator accountable for
their late reporting? Answer: No, the sponsor should support the
conduct QC activities with the sites to help them ensure timely SAE
reporting.
