Clinical Safety Data Management Flashcards
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
An adverse event is defined as one which
c) Is not necessarily causally related to drug
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
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
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
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
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
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
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
An adverse drug reaction is one which
b) A noxious and unintended response to a drug
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
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
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
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
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
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
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
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
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
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
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
Events which may be classified as serious even though they do not result in hospitalization include
d) All of the above
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
An unexpected adverse reaction is one which is
b) Not mentioned in the investigator’s brochure or relevant source document
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
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
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
For expedited reporting and event must be
b) Serious and unexpected
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
According to ICH serious unexpected reaction toa drug should be
a) Submitted to the appropriate regulatory authority within one week
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
Clinical investigation of adverse events in clinical trials requires
a) Root cause analysis
Adverse events of marketed drugs usually imply
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality
Adverse events of marketed drugs usually imply
d) Causality
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
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
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
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
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
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
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
Serious adverse drug reactions must be filed with regulatory agencies
c) As soon as possible, but not later than 15 days of first knowledge
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
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
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
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
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
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
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
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
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
New safety information regarding a study drug should be updated by the sponsor by
d) Updating the Investigator’s Brochure
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
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
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
An adverse event that is severe in intensity
c) May not meet the definition of a serious adverse event
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
To be characterized as severe an adverse event is one
d) That merely describes the intensity of the medical event
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
Which of the following statements is correct?
d) None of the above
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
An adverse drug reaction is one which
c) Has a reasonable suspected causal relationship to the drug
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
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
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
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
