Unanticipated Events Flashcards
The most important consideration in reporting an adverse event in a clinical trial is?
a) Whether the event occurred in the time frame of drug administration
b) Whether the event is reported as drug related by the research subject
c) Whether the event is listed as an adverse event in the investigator’s brochure
d) Whether the event is listed as an adverse event in the protocol.
a) Whether the event occurred in the time frame of drug administration
Timely and accurate reporting of an adverse event is most important for?
a) Ensuring drug approval by the regulatory agency
b) Prevention of study suspension by the IRB
c) Updating the consent form
d) Protection of subject safety
d) Protection of subject safety
A research subject enrolled in a clinical trial is involved in a car accident and suffers significant physical injuries. The event occurs while the drug administration phase of the protocol is still ongoing. The investigator should?
a) Report the event to the sponsor and the IRB
b) Not report the event
c) Report the event to the REGULATORY AGENCY
d) Report the event to OHRP
a) Report the event to the sponsor and the IRB
A research subject enrolled in a clinical trial experiences significant chest pain and is admitted to the emergency department for the possible evaluation of a cardiac event. The event occurs while the drug administration is still ongoing in the clinical trial. The causality of the event should be determined by?
a) The principal investigator
b) The study sponsor
c) The IRB
d) The subject’s personal physician
a) The principal investigator
The sponsor must report a serious adverse event in an IND safety report to the regulatory agency if the event is?
a) Serious, unanticipated and possibly related to the drug
b) Serious regardless of anticipatedness or proof of relatedness
c) Mentioned as a high risk event in the investigator’s brochure
d) Stated in the informed consent
a) Serious, unanticipated and possibly related to the drug
A research subject in clinical trial under IND experiences difficulty breathing and self admits to the emergency department. The investigator should?
a) Submit the SAE report to the sponsor only
b) Not report the event as the admission to the emergency department was self-reported
c) Report the event to the IRB but not the study sponsor
d) Report the event to the study sponsor and the IRB
d) Report the event to the study sponsor and the IRB
Reporting a health related adverse event in clinical trial as serious, unanticipated and possibly related are criteria required by?
a) The REGULATORY AGENCY and the IRB
b) OHRP
c) The sponsor’s instruction to the investigator
d) The subject’s personal physician
a) The REGULATORY AGENCY and the IRB
In clinical trial under an IND Subject A experiences difficulty breathing and self admits to the emergency room. Subject B experiences nausea and vomiting which is resolved by home rest for a day. Which event should be reported as “serious” to the regulatory agency?
a) Subject A
b) Subject B
c) Subjects A and B
d) Neither subject.
a) Subject A
In a clinical trial, reports of adverse events from the investigator to the sponsor should include?
a) Any adverse event observed in the subject
b) Only events which meet the definition of a serious event
c) Only events which are unanticipated
d) Only events which meet the definition of possibly related to drug
a) Any adverse event observed in the subject
For an adverse event to be characterized as unexpected OHRP guidance advises that the event should be in nature, severity or frequency be?
a) Not listed in the research protocol
b) Not listed in the informed consent
c) Not a characteristic of the study population
d) All of the above
d) All of the above
a) Not listed in the research protocol
b) Not listed in the informed consent
c) Not a characteristic of the study population
According to OHRP guidance, corrective actions which may be needed in response to an unexpected problem include?
a) Modification of the research protocol including eligibility criteria
b) Modification of informed consent and
re-consent of currently enrolled subjects
c) Suspension of new enrollment and of current procedures in enrolled subjects
d) All of the above.
d) All of the above.
a) Modification of the research protocol including eligibility criteria
b) Modification of informed consent and
re-consent of currently enrolled subjects
c) Suspension of new enrollment and of current procedures in enrolled subjects
In a clinical trial under an IND the investigator determines that a protocol procedure should be changed immediately in consideration of patient safety. He does not inform the IRB or the sponsor?
a) His action is approvable under regulations
b) His action constitutes serious noncompliance
c) His action merits study suspension
d) His action merits disciplinary action from the institution
a) His action is approvable under regulations
Adverse events encompass?
a) Physical harms only
b) Psychological harms only
c) Physical and psychological harms
d) Harms determined as relevant and serious by the investigator.
c) Physical and psychological harms
According to OHRP an adverse event represents an unanticipated problem if it is?
a) Unexpected, possibly related to participation
b) Unexpected and meets the REGULATORY AGENCY definition of serious
c) Possibly related to participation even if expected
d) Unexpected, possibly related to participation and places the subject or others at a greater risk of harm than previously recognized.
d) Unexpected, possibly related to participation and places the subject or others at a greater risk of harm than previously recognized.
An adverse event is defined as serious if it is?
a) Death or life threatening event
b) Results in hospitalization or prolongation of a hospitalization
c) Results in a persistent or significant disability
d) Results in a congenital anomaly or birth defect
e) Any of the above
e) Any of the above
a) Death or life threatening event
b) Results in hospitalization or prolongation of a hospitalization
c) Results in a persistent or significant disability
d) Results in a congenital anomaly or birth defect
With regard to obtaining continued approval of a clinical trial, the IRB has the authority to require additional detailed information from?
a) The investigator only
b) The investigator and the sponsor
c) The study coordinating center
d) The investigator, the sponsor, the coordinating center and the DSMB.
d) The investigator, the sponsor, the coordinating center and the DSMB.
According to OHRP guidance unanticipated problems which are serious should be reported to the IRB within?
a) One day
b) One week
c) Two weeks
d) One month
b) One week
According to OHRP guidance unanticipated problems which are other than serious should be reported to the IRB within?
a) One day
b) One week
c) Two weeks
d) One month
c) Two weeks
In a clinical trial a serious adverse event should be reported by the investigator to the sponsor within?
a) Promptly
b) Seven days
c) Fifteen days
d) One month
a) Promptly
With respect to monitoring of adverse events in a clinical trial, the IRB should consider?
a) The type of data, events and the entity responsible for reporting
b) The time frame and frequency of assessments of events and their relationship to stopping rules
c) The appropriate procedures for timely communication of the monitoring results to the IRB and sponsor
d) All of the above
d) All of the above
a) The type of data, events and the entity responsible for reporting
b) The time frame and frequency of assessments of events and their relationship to stopping rules
c) The appropriate procedures for timely communication of the monitoring results to the IRB and sponsor
In order to distinguish an event as being probably versus possibly related to a drug it is important to eliminate?
a) Natural progression of disease or disease related events
b) Contributions from concomitant medications’
c) Both a and b
d) Neither a nor b
c) Both a and b
An investigator conducting a study of illicit drug behavior has the data on a laptop in an unencrypted fashion. The laptop is stolen. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under DHHS regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulations
d) DHHS regulations do not apply
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations
A pharmacist makes a dosing error in a clinical trial that results in no harm to any subject. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under DHHS regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulations
d) DHHS regulations do not apply
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations
Subjects in a cancer trial received serum that was not screened for the hepatitis virus. No illness in subjects is reported. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under DHHS regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulations
d) DHHS regulations do not apply
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations
A subject in an oncology trial develops multi organ failure and dies. The event is a known complication of the disease and standard therapy and is described in an IRB approved protocol. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulations
d) DHHS regulations do not apply
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations
A subject in a psychology study requires sequestration in small space and develops claustrophobia which is described as one of the risks in the IRB approved protocol. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulations
d) DHHS regulations do not apply
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations
An investigator carries out prospective chart reviews of neonates in the intensive care unit. One of the neonates dies. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulations
d) DHHS regulations do not apply
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations
A subject in clinical trial for Gi reflux disease develops renal failure, an event not described in the protocol or informed consent. The event is?
a) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulations
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under DHHS regulations
c) Adverse event that does represent an unanticipated problem that needs to be reported under regulations
d) Regulations do not apply
c) Adverse event that does represent an unanticipated problem that needs to be reported under regulations
With regard to reporting serious adverse events to the DSMB the sponsor should?
a) Report all serious events to the DSMB
b) Forward only the IND safety reports sent to the REGULATORY AGENCY to the DSMB
c) Forward only the events reported to the IRB
d) Forward only the events to be reported to the funding agency
a) Report all serious events to the DSMB
