CCRC Exam Question Bank
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 - correct answer ✔✔b and c
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 - correct answer ✔✔b
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 - correct answer ✔✔d
A patient in a clinical trial for joint pain experiences a bronchospasm while at home. The event would be:
a. not reportable bc 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 - correct answer ✔✔d
According to ICH, 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 - correct answer ✔✔c
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 - correct answer ✔✔a
Adverse events of marketed drugs usually imply:
a. multi-drug interactions
b. unreliable subjective measures
c. psychosomatic factors
d. causality - correct answer ✔✔d
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 - correct answer ✔✔d
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 - correct answer ✔✔a
and c
Serious adverse drug reactions must be filed with regulatory agencies:
a. ASAP, but no later than 8 days of first knowledge
b. ASAP, but no later than 10 days of first knowledge
c. ASAP, but no later than 15 days of first knowledge
d. ASAP, but no later than 1 month of first knowledge - correct answer ✔✔c
In ascertaining the basis of a serious adverse drug reaction in a randomized trial,
a. care should be taken not to break the blind for the patient
b. care should be taken to break the blind only for the single patient involved
c. the blind for the group of patients being treated at the site should be broken
d. the blind for the single patient should be broken only if the sponsor approves - correct answer ✔✔b
Breaking the blind for a single patient in a randomized clinical trial:
a. has negative implications of data integrity at the site level
b. has little or no significant implication for the investigation or final data analysis
c. may compromise drug approval bc of implications for final data analysis
d. provides no significant information regarding the safety of the patient - correct answer ✔✔b
Adverse drug reactions in the control group should be reported to:
a. the other manufacturer
b. appropriate regulatory agency
c. a only
d. a and b - correct answer ✔✔d
An adverse reaction occurs in patients after the study has been completed. The appropriate action on
the part of the investigator include:
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 - correct answer ✔✔b and c
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 - correct answer ✔✔b
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 - correct answer ✔✔d
A patient in a clinical trial for joint pain experiences a bronchospasm while at home. The event would be:
a. not reportable bc 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 - correct answer ✔✔d
According to ICH, 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 - correct answer ✔✔c
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 - correct answer ✔✔a
Adverse events of marketed drugs usually imply:
a. multi-drug interactions
b. unreliable subjective measures
c. psychosomatic factors
d. causality - correct answer ✔✔d
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 - correct answer ✔✔d
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 - correct answer ✔✔a
and c
Serious adverse drug reactions must be filed with regulatory agencies:
a. ASAP, but no later than 8 days of first knowledge
b. ASAP, but no later than 10 days of first knowledge
c. ASAP, but no later than 15 days of first knowledge
d. ASAP, but no later than 1 month of first knowledge - correct answer ✔✔c
In ascertaining the basis of a serious adverse drug reaction in a randomized trial,
a. care should be taken not to break the blind for the patient
b. care should be taken to break the blind only for the single patient involved
c. the blind for the group of patients being treated at the site should be broken
d. the blind for the single patient should be broken only if the sponsor approves - correct answer ✔✔b
Breaking the blind for a single patient in a randomized clinical trial:
a. has negative implications of data integrity at the site level
b. has little or no significant implication for the investigation or final data analysis
c. may compromise drug approval bc of implications for final data analysis
d. provides no significant information regarding the safety of the patient - correct answer ✔✔b
Adverse drug reactions in the control group should be reported to:
a. the other manufacturer
b. appropriate regulatory agency
c. a only
d. a and b - correct answer ✔✔d
An adverse reaction occurs in patients after the study has been completed. The appropriate action on
the part of the investigator include:
