ACRP CCRC EXAM PREP QUESTIONS UPDATED AND
CORRECT ANSWERS UPDATED QUESTIONS AND
CORRECT ANSWERS
Question:
1. What are expected or possible conse-quences of over-estimation of recruit-ment potential?
Answer:
- The trial will overrun its projected timeline
- The recruitment period will be prolonged and
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
Question:
2. What should be the first consideration when conducting a clinical trial?
Answer:
Subject welfare
Question:
3. When is the investigator allowed to de-viate from the protocol?
Answer:
When there is an immediate hazard to a patient.
Question:
4. 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
Question:
5. Which conditions should be fulfilled when enrolling a subject into your trial?
Answer:
- Subject meets all inclusion criteria
- Subject has given written informed consent
Question:
6. 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 record-ing
machine in the storage room has failed so you doin't know what the tem-perature 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
Question:
7. A protocol amendment was issued for a trial. Your site received IRB approval for the amendment
and wants to im-plement the increase in PO dose for your trial subjects as identified in the
amendment trial subjects. As delegat-ed consenting duties you must re-con-sent trial subjects before
being able to administer the adjusted dose. You de-cide 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 tri-al and therefore need to be updated on any changes to the
protocol.
Question:
8. 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 ex-clude
the subject from the trial immediately.
Question:
9. A patient cannot recall the name of the heart condition medication he took a few years ago. This is
important infor-mation for deciding whether the pa-tient may be enrolled in a clinical trial (IC/EC).
What's your best course of ac-tion?
Answer:
You attempt to retrieve the patients medical his-tory by contacting previous caregivers and you wait
for additional information before enroll-ment.
Question:
10. Who has ultimate trial responsibility for each subject?
Answer:
The principle investigator.
Question:
11. A trial subject suffers from severe re-peat headaches. Should this adverse event be reported to the
IRB?
Answer:
No
Question:
12. 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 medica-
tion
- All ADRs must be documented
,Question:
13. 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
Question:
14. During a study visit a patient tells the investigator that she visited an emer-gency room and
received intensive treatment for allergic bronchospasm. Since the patient was in the emergency room
for only three hours, the investi-gator did not assess the event as seri-ous. Is this a correct assessment?
Answer:
No, this would be a medically important event and should be considered serious
Question:
15. 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
Question:
16. During a visit with investigator, a sub-ject reported feeling heart palpitations for a brief period of
time during the pre-vious evening. The heart palpitations resolved without reoccurrence. The
in-vestigator 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 ad-
verse events
Question:
17. When asked by a regulatory body why they received SAE related informa-tion on 12/2013 from
an incident that occurred in 5/2013, the sponsor ex-plained the reason being they received the trial
related SAE information from the investigator in 12/2013. Is the spon-sor correct in only holding the
investi-gator accountable for their late report-ing?
Answer:
No, the sponsor should support the conduct QC activities with the sites to help them ensure time-ly
SAE reporting.
Question:
18. A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator
considers this event possibly related to the study drug even though this is not listed in the IB as a
potential adverse reaction. What would the investigator report this event to the sponsor as?
Answer:
An unexpected, serious adverse event
, Question:
19. A 22y/o male was entered into a clini-cal study for treatment of schizophre-nia The study drug
was administered orally, BID. One week later, the subject visited the investigator complaining of
sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug. How
should this severe throat be classified?
Answer:
- An adverse event
- An adverse drug reaction
Question:
20. In regards to AE and ADR reporting, what statements are true?
Answer:
- All ADRs are AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions
is an AE -Preplanned hospitalization is usually not an SAE
Question:
21. What determines the causality of an ad-verse event?
Answer:
The investigator
Question:
22. Which term best describes the cycli-cal process that involves the Plan, Do, Check, Act activities?
Answer:
Quality improvement
Question:
23. Which term best describes an indepen-dent assessment of completed work to ensure it will meet
applicable quality standards?
Answer:
Quality assurance
Question:
24. Which term best describes the activities done to ensure quality output?
Answer:
Quality control
Question:
25. Which term requires structure and a definition of acceptable standards of performance?
Answer:
Quality planning
Question:
26. Which is represented in ALCOA-C?
Answer:
Attributable
CORRECT ANSWERS UPDATED QUESTIONS AND
CORRECT ANSWERS
Question:
1. What are expected or possible conse-quences of over-estimation of recruit-ment potential?
Answer:
- The trial will overrun its projected timeline
- The recruitment period will be prolonged and
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
Question:
2. What should be the first consideration when conducting a clinical trial?
Answer:
Subject welfare
Question:
3. When is the investigator allowed to de-viate from the protocol?
Answer:
When there is an immediate hazard to a patient.
Question:
4. 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
Question:
5. Which conditions should be fulfilled when enrolling a subject into your trial?
Answer:
- Subject meets all inclusion criteria
- Subject has given written informed consent
Question:
6. 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 record-ing
machine in the storage room has failed so you doin't know what the tem-perature 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
Question:
7. A protocol amendment was issued for a trial. Your site received IRB approval for the amendment
and wants to im-plement the increase in PO dose for your trial subjects as identified in the
amendment trial subjects. As delegat-ed consenting duties you must re-con-sent trial subjects before
being able to administer the adjusted dose. You de-cide 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 tri-al and therefore need to be updated on any changes to the
protocol.
Question:
8. 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 ex-clude
the subject from the trial immediately.
Question:
9. A patient cannot recall the name of the heart condition medication he took a few years ago. This is
important infor-mation for deciding whether the pa-tient may be enrolled in a clinical trial (IC/EC).
What's your best course of ac-tion?
Answer:
You attempt to retrieve the patients medical his-tory by contacting previous caregivers and you wait
for additional information before enroll-ment.
Question:
10. Who has ultimate trial responsibility for each subject?
Answer:
The principle investigator.
Question:
11. A trial subject suffers from severe re-peat headaches. Should this adverse event be reported to the
IRB?
Answer:
No
Question:
12. 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 medica-
tion
- All ADRs must be documented
,Question:
13. 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
Question:
14. During a study visit a patient tells the investigator that she visited an emer-gency room and
received intensive treatment for allergic bronchospasm. Since the patient was in the emergency room
for only three hours, the investi-gator did not assess the event as seri-ous. Is this a correct assessment?
Answer:
No, this would be a medically important event and should be considered serious
Question:
15. 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
Question:
16. During a visit with investigator, a sub-ject reported feeling heart palpitations for a brief period of
time during the pre-vious evening. The heart palpitations resolved without reoccurrence. The
in-vestigator 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 ad-
verse events
Question:
17. When asked by a regulatory body why they received SAE related informa-tion on 12/2013 from
an incident that occurred in 5/2013, the sponsor ex-plained the reason being they received the trial
related SAE information from the investigator in 12/2013. Is the spon-sor correct in only holding the
investi-gator accountable for their late report-ing?
Answer:
No, the sponsor should support the conduct QC activities with the sites to help them ensure time-ly
SAE reporting.
Question:
18. A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator
considers this event possibly related to the study drug even though this is not listed in the IB as a
potential adverse reaction. What would the investigator report this event to the sponsor as?
Answer:
An unexpected, serious adverse event
, Question:
19. A 22y/o male was entered into a clini-cal study for treatment of schizophre-nia The study drug
was administered orally, BID. One week later, the subject visited the investigator complaining of
sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug. How
should this severe throat be classified?
Answer:
- An adverse event
- An adverse drug reaction
Question:
20. In regards to AE and ADR reporting, what statements are true?
Answer:
- All ADRs are AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions
is an AE -Preplanned hospitalization is usually not an SAE
Question:
21. What determines the causality of an ad-verse event?
Answer:
The investigator
Question:
22. Which term best describes the cycli-cal process that involves the Plan, Do, Check, Act activities?
Answer:
Quality improvement
Question:
23. Which term best describes an indepen-dent assessment of completed work to ensure it will meet
applicable quality standards?
Answer:
Quality assurance
Question:
24. Which term best describes the activities done to ensure quality output?
Answer:
Quality control
Question:
25. Which term requires structure and a definition of acceptable standards of performance?
Answer:
Quality planning
Question:
26. Which is represented in ALCOA-C?
Answer:
Attributable
