Clinical Safety Data Management

Question 1

An adverse event is defined as one which
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to drug
d) Is life threatening

Answer 1

An adverse event is defined as one which
c) Is not necessarily causally related to drug

Question 2

An adverse event is one which
a) Is an unfavorable and unintended sign, symptom or disease
b) Is one that is temporally associated with drug regardless of whether it is related or not
c) a only
d) a and b

Answer 2

An adverse event is one which
d) a and b

a) Is an unfavorable and unintended sign,
symptom or disease
b) Is one that is temporally associated with
drug regardless of whether it is related or
not

Question 3

A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as
a) An adverse event
b) An adverse drug reaction
c) An unexpected adverse drug reaction
d) A serious adverse event

Answer 3

A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as
a) An adverse event

Question 4

A response to a medical product means (check all options 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 4

A response to a medical product means (check all options that apply)
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

Question 5

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 5

An adverse drug reaction is one which
b) A noxious and unintended response to a drug

Question 6

For a drug that is in a Phase IV trial and 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

Answer 6

For a drug that is in a Phase IV trial and adverse drug reaction is one which
d) a and b

a) Is noxious and unintended
b) Occurs at normal doses used for
prophylaxis

Question 7

A serious adverse event is one which results in
a) Death or life threatening event
b) A hospitalization or prolongation of hospitalization
c) Persistent or significant disability
d) Congenital anomaly or birth defect
e) All of the above

Answer 7

A serious adverse event is one which results in
e) All of the above

a) Death or life threatening event
b) A hospitalization or prolongation of hospitalization
c) Persistent or significant disability
d) Congenital anomaly or birth defect

Question 8

The term, life threatening, in a serious adverse event refers to
a) An event which required hospitalization
b) An event where risk of death was evident at the time of the event
c) An event that required treatment in an emergency room
d) An event which might have caused a death if left untreated

Answer 8

The term, life threatening, in a serious adverse event refers to
b) An event where risk of death was evident at the time of the event

Question 9

An event may be classified as serious if it
a) Not immediately life threatening, but may jeopardize the patient
b) Not immediately life threatening but may require and intervention to prevent hospitalization
c) a only
d) a and b

Answer 9

An event may be classified as serious if it
d) a and b

a) Not immediately life threatening, but may jeopardize the patient
b) Not immediately life threatening but may require and intervention to prevent hospitalization

Question 10

A patient in a clinical I 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 10

A patient in a clinical I trial for joint pain experiences a bronchospasm while at home. The event would be
d) May be considered serious and should be considered for expedited reporting

Question 11

Events which may be classified as serious even though they do not result in hospitalization include
a) Allergic bronchospasm
b) Blood dyscrasias
c) Convulsions
d) All of the above

Answer 11

Events which may be classified as serious even though they do not result in hospitalization include
d) All of the above

Question 12

An unexpected adverse reaction is one which is
a) Not expected by the investigator
b) Not mentioned in the investigator’s brochure or relevant source document
c) Classified as such by the IRB
d) Classified as such by the sponsor’s medical safety officer

Answer 12

An unexpected adverse reaction is one which is
b) Not mentioned in the investigator’s brochure or relevant source document

Question 13

Which of the following is an unexpected adverse event?
a) A report which adds significant information to an already documented serious adverse event
b) A report of interstitial nephritis in a patient with acute renal failure
c) A report of fulminant hepatitis in patient with an initial report of hepatitis
d) All of the above

Answer 13

Which of the following is an unexpected adverse event?
d) All of the above

a) A report which adds significant information to an already documented serious adverse event
b) A report of interstitial nephritis in a patient with acute renal failure
c) A report of fulminant hepatitis in patient with an initial report of hepatitis

Question 14

For expedited reporting and event must be
a) Serious
b) Serious and unexpected
c) Only temporally associated with drug administration
d) Causally related to drug administration

Answer 14

For expedited reporting and event must be
b) Serious and unexpected

Question 15

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

Answer 15

According to ICH serious unexpected reaction toa drug should be
a) Submitted to the appropriate regulatory authority within one week

Question 16

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 16

Clinical investigation of adverse events in clinical trials requires
a) Root cause analysis

Question 17

Adverse events of marketed drugs usually imply
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality

Answer 17

Adverse events of marketed drugs usually imply
d) Causality

Question 18

Rapid communication of single case reports of serious adverse events is merited if the information
a) Influences risk benefit assessment
b) Implies a change need in drug administration
c) A change in the conduct of the clinical investigation
d) All of the above

Answer 18

Rapid communication of single case reports of serious adverse events is merited if the information
d) All of the above

a) Influences risk benefit assessment
b) Implies a change need in drug administration
c) A change in the conduct of the clinical investigation

Question 19

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 19

Expedited reporting of serious adverse events may be considered if
d) All of the above

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

Question 20

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 20

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
c) By filing a complete report within 8 additional days of the initial notification

Question 21

Serious adverse drug reactions must be filed with regulatory agencies
a) As soon as possible, but not later than 8 days of first knowledge
b) As soon as possible, but not later than 10 days of first knowledge
c) As soon as possible, but not later than 15 days of first knowledge
d) As soon as possible, but not later than 1 month of first knowledge

Answer 21

Serious adverse drug reactions must be filed with regulatory agencies
c) As soon as possible, but not later than 15 days of first knowledge

Question 22

In ascertaining the basis for 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

Answer 22

In ascertaining the basis for a serious adverse drug reaction in a randomized trial
b) Care should be taken to break the blind only for the single patient involved

Question 23

Breaking the blind for a single patient in randomized clinical trial
a) Has negative implications for 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 because of implications for final data analysis
d) Provides no significant information regarding the safety of the patient

Answer 23

Breaking the blind for a single patient in randomized clinical trial
b) Has little or no significant implication for the investigation or final data analysis

Question 24

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

Answer 24

Adverse drug reactions in the control group should be reported to
d) a and b
a) The other manufacturer
b) Appropriate regulatory agency
c) a only

Question 25

An adverse reaction occurs in patients after the study has been completed. The appropriate action on the part of the investigator include
a) Report the event to the sponsor
b) Consider the event for reporting as though it was a study report
c) Conduct causality assessment and determination of expectedness prior to expedited reporting
d) All of the above

Answer 25

An adverse reaction occurs in patients after the study has been completed. The appropriate action on the part of the investigator include
d) all of the above

a) Report the event to the sponsor
b) Consider the event for reporting as though it was a study report
c) Conduct causality assessment and determination of expectedness prior to expedited reporting

Question 26

New safety information regarding a study drug should be updated by the sponsor by
a) Notifying the IRB
b) Notifying the investigator
c) Updating the protocol
d) Updating the Investigator’s Brochure

Answer 26

New safety information regarding a study drug should be updated by the sponsor by
d) Updating the Investigator’s Brochure

Question 27

An unexpected adverse drug reaction is a reaction
a) Happens immediately after drug administration
b) Is inconsistent with the documented product information in the investigator’s brochure or other source document
c) Known to occur frequently in preclinical studies
d) Dependent on the dose the drug

Answer 27

An unexpected adverse drug reaction is a reaction
b) Is inconsistent with the documented product information in the investigator’s brochure or other source document

Question 28

An adverse event that is severe in intensity
a) May qualify for expedited reporting
b) Could be classified as a serious adverse event
c) May not meet the definition of a serious adverse event
d) Need not be reported to the sponsor if it is part of the disease condition

Answer 28

An adverse event that is severe in intensity
c) May not meet the definition of a serious adverse event

Question 29

To be characterized as severe an adverse event is one
a) That qualifies for expedited reporting
b) Is always life threatening
c) Is always one that can be characterized as serious
d) That merely describes the intensity of the medical event

Answer 29

To be characterized as severe an adverse event is one
d) That merely describes the intensity of the medical event

Question 30

Which of the following statements is correct?
a) An adverse event is one that is always viewed as potentially serious
b) An adverse event is an adverse drug reaction
c) An adverse event qualifies for expedited reporting
d) None of the above

Answer 30

Which of the following statements is correct?
d) None of the above

Question 31

An adverse drug reaction is one which
a) Always associated with a hospitalization
b) Qualifies for expedited reporting
c) Has a reasonable suspected causal relationship to the drug
d) Can usually be characterized as severe

Answer 31

An adverse drug reaction is one which
c) Has a reasonable suspected causal relationship to the drug

Question 32

In a clinical trial of congestive heart failure a hospitalization for one day until acute symptoms resolve is considered usual. Patient X was hospitalized for a period for five days.
This event
a) Is an adverse event
b) Unexpected adverse drug reaction
c) A serious adverse drug reaction
d) Cannot be characterized as serious as it is reflective of the disease and not the drug

Answer 32

In a clinical trial of congestive heart failure a hospitalization for one day until acute symptoms resolve is considered usual. Patient X was hospitalized for a period for five days.
This event
c) A serious adverse drug reaction

Question 33

A serious adverse event which has resulted in death requires
a) An autopsy report
b) A detailed account of relationship to drug
c) A definitive exclusion of the effects of concomitant drugs
d) All of the above

Answer 33

A serious adverse event which has resulted in death requires
d) All of the above

a) An autopsy report
b) A detailed account of relationship to drug
c) A definitive exclusion of the effects of concomitant drugs