ACRP CCRC Certification Exam Study Guide |
Advanced Practice Exam Questions with Verified
Answers & Detailed Rationales | Latest Update
2026/2027 -Graded A+
Question 1
A response to a medical product means (check all that apply):
A. A causal relationship between drug and adverse event is established
B. A causal relationship between drug and adverse event is a reasonable possibility
C. The relationship of the event to drug cannot be ruled out
D. An event that requires active medical intervention
Answer: B, C
Rationale: In pharmacovigilance, a response to a medical product does not require a
proven causal relationship. It is sufficient that a causal relationship is a reasonable
possibility or cannot be ruled out. This forms the basis for adverse event reporting.
Question 2
An adverse drug reaction is one which:
A. Results in death or hospitalization
B. A noxious and unintended response to a drug
C. Occurs frequently and with greater severity than usual
D. Likely occurs at normal doses of the drug
Answer: B
Rationale: An adverse drug reaction (ADR) is defined as a noxious and unintended
response to a drug that occurs at doses normally used in humans for prophylaxis,
diagnosis, or therapy.
Question 3
For a drug that is in a Phase IV trial, an adverse drug reaction is one which:
A. Is noxious and unintended
B. Occurs at normal doses used for prophylaxis
C. A only
D. A and B
pg. 1
,Answer: D
Rationale: In Phase IV trials, ADRs are defined as noxious and unintended responses
that occur at normal doses used for prophylaxis, diagnosis, or therapy. Both criteria
apply.
Question 4
A patient in a clinical trial for joint pain experiences a bronchospasm while at home. The
event would be:
A. Not reportable because it occurred in a home setting
B. An adverse event which does not require reporting
C. An unexpected adverse event which does not require expedited reporting
D. May be considered serious and should be considered for expedited reporting
Answer: D
Rationale: Bronchospasm is a serious medical event. The location (home) does not
affect reporting requirements. Any serious, unexpected event should be considered for
expedited reporting.
Question 5
According to ICH, a serious unexpected reaction to a drug should be:
A. Submitted to the appropriate regulatory authority within one week
B. Submitted to the appropriate regulatory authority within 15 days
C. Submitted to the appropriate regulatory authority on an expedited basis
D. Submitted promptly to the IRB
Answer: C
Rationale: ICH guidelines require that serious unexpected adverse drug reactions be
reported on an expedited basis (usually within 15 days, or 7 days for fatal/life-
threatening events).
Question 6
Clinical investigation of adverse events in clinical trials requires:
A. Root cause analysis
B. Complete medical records review
C. Investigation of potential protocol deviations
D. Causality assessment
Answer: A
pg. 2
, Rationale: Clinical investigation of adverse events requires root cause analysis to
determine the underlying cause and prevent recurrence.
Question 7
Adverse events of marketed drugs usually imply:
A. Multi-drug interactions
B. Unreliable subjective measures
C. Psychosomatic factors
D. Causality
Answer: D
Rationale: Adverse events of marketed drugs imply a potential causal relationship
between the drug and the event, requiring investigation and reporting.
Question 8
Expedited reporting of serious adverse events may be considered if:
A. There is an increased rate of occurrence in the serious adverse drug reaction
B. A lack of efficacy is evident in treating a life-threatening disease
C. A new safety consideration is evident from a new animal study
D. All of the above
Answer: D
Rationale: Expedited reporting is warranted for increased occurrence rates, lack of
efficacy in life-threatening diseases, and new safety considerations from animal studies.
Question 9
Fatal or life-threatening and unexpected adverse drug reactions in clinical investigations
should be reported to the regulatory agencies: (check all that apply)
A. No later than 7 days after first knowledge of event
B. No later than 15 days after first knowledge of event
C. By filing a complete report within 8 additional days of the initial notification
D. By filing a complete report within 15 additional days of the initial notification
Answer: A, C
Rationale: Fatal or life-threatening unexpected ADRs must be reported within 7 days,
with a complete follow-up report within 8 additional days (total 15 days).
pg. 3
Advanced Practice Exam Questions with Verified
Answers & Detailed Rationales | Latest Update
2026/2027 -Graded A+
Question 1
A response to a medical product means (check all that apply):
A. A causal relationship between drug and adverse event is established
B. A causal relationship between drug and adverse event is a reasonable possibility
C. The relationship of the event to drug cannot be ruled out
D. An event that requires active medical intervention
Answer: B, C
Rationale: In pharmacovigilance, a response to a medical product does not require a
proven causal relationship. It is sufficient that a causal relationship is a reasonable
possibility or cannot be ruled out. This forms the basis for adverse event reporting.
Question 2
An adverse drug reaction is one which:
A. Results in death or hospitalization
B. A noxious and unintended response to a drug
C. Occurs frequently and with greater severity than usual
D. Likely occurs at normal doses of the drug
Answer: B
Rationale: An adverse drug reaction (ADR) is defined as a noxious and unintended
response to a drug that occurs at doses normally used in humans for prophylaxis,
diagnosis, or therapy.
Question 3
For a drug that is in a Phase IV trial, an adverse drug reaction is one which:
A. Is noxious and unintended
B. Occurs at normal doses used for prophylaxis
C. A only
D. A and B
pg. 1
,Answer: D
Rationale: In Phase IV trials, ADRs are defined as noxious and unintended responses
that occur at normal doses used for prophylaxis, diagnosis, or therapy. Both criteria
apply.
Question 4
A patient in a clinical trial for joint pain experiences a bronchospasm while at home. The
event would be:
A. Not reportable because it occurred in a home setting
B. An adverse event which does not require reporting
C. An unexpected adverse event which does not require expedited reporting
D. May be considered serious and should be considered for expedited reporting
Answer: D
Rationale: Bronchospasm is a serious medical event. The location (home) does not
affect reporting requirements. Any serious, unexpected event should be considered for
expedited reporting.
Question 5
According to ICH, a serious unexpected reaction to a drug should be:
A. Submitted to the appropriate regulatory authority within one week
B. Submitted to the appropriate regulatory authority within 15 days
C. Submitted to the appropriate regulatory authority on an expedited basis
D. Submitted promptly to the IRB
Answer: C
Rationale: ICH guidelines require that serious unexpected adverse drug reactions be
reported on an expedited basis (usually within 15 days, or 7 days for fatal/life-
threatening events).
Question 6
Clinical investigation of adverse events in clinical trials requires:
A. Root cause analysis
B. Complete medical records review
C. Investigation of potential protocol deviations
D. Causality assessment
Answer: A
pg. 2
, Rationale: Clinical investigation of adverse events requires root cause analysis to
determine the underlying cause and prevent recurrence.
Question 7
Adverse events of marketed drugs usually imply:
A. Multi-drug interactions
B. Unreliable subjective measures
C. Psychosomatic factors
D. Causality
Answer: D
Rationale: Adverse events of marketed drugs imply a potential causal relationship
between the drug and the event, requiring investigation and reporting.
Question 8
Expedited reporting of serious adverse events may be considered if:
A. There is an increased rate of occurrence in the serious adverse drug reaction
B. A lack of efficacy is evident in treating a life-threatening disease
C. A new safety consideration is evident from a new animal study
D. All of the above
Answer: D
Rationale: Expedited reporting is warranted for increased occurrence rates, lack of
efficacy in life-threatening diseases, and new safety considerations from animal studies.
Question 9
Fatal or life-threatening and unexpected adverse drug reactions in clinical investigations
should be reported to the regulatory agencies: (check all that apply)
A. No later than 7 days after first knowledge of event
B. No later than 15 days after first knowledge of event
C. By filing a complete report within 8 additional days of the initial notification
D. By filing a complete report within 15 additional days of the initial notification
Answer: A, C
Rationale: Fatal or life-threatening unexpected ADRs must be reported within 7 days,
with a complete follow-up report within 8 additional days (total 15 days).
pg. 3
