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SOCRA REAL EXAM AND STUDY GUIDE LATESTE , 200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED A+ Accurate reporting of adverse events is most important for$20.49
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SOCRA REAL EXAM AND STUDY GUIDE LATESTE , 200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED A+ Accurate reporting of adverse events is most important for
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SOCRA REAL
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SOCRA REAL
SOCRA REAL EXAM AND STUDY GUIDE LATESTE ,
200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED
A+
Accurate reporting of adverse events is most important for
SOCRA REAL EXAM AND STUDY GUIDE LATESTE ,
200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED
A+
Accurate reporting of adverse events is...
SOCRA REAL EXAM AND STUDY GUIDE LATESTE 2024-2025,
200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED
A+
Accurate reporting of adverse events is most important for
A. Updating recruitment materials.
B. Allowing re-challenge of subjects.
C. Ensuring correct site reimbursement for work performed.
D. Ensuring subject safety. - ANSWER-D. Ensuring subject safety.
A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject
sustained a broken wrist and mild concussion. The subject was treated and released from the
emergency department. What should the investigator do when learning of the crash?
A. Report adverse events of both a broken wrist and a mild concussion to the Sponsor according to the
timetable specified in the protocol.
B. No report is needed because the subject was a passenger in the vehicle and not driving.
C. No report is needed because these are not serious adverse events.
D. Report both a broken wrist and a mild concussion to the Sponsor immediately. - ANSWER-A. Report
adverse events of both a broken wrist and a mild concussion to the Sponsor according to the timetable
specified in the protocol.
A subject presents to the emergency department (ED) with complaints of chest pain and shortness of
breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a
history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a
Phase 1 study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event?
A. Pharmacist
B. Sponsor
C. ED nurse
D. Investigator - ANSWER-B. Sponsor
The sponsor must submit an IND safety report to the FDA if a suspected adverse reaction is both related
to the use of the investigational agent AND:
,A. Can reasonably be expected to recur
B. Resolves quickly
C. Is unexpected
D. Is life-threatening but listed in the Investigator's Brochure - ANSWER-C. Is unexpected
A double-blinded trial for a new indication is conducted under an IND comparing 2 marketed drugs, at
twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing, although it was life-
threatening initially, subject 603 was treated and discharged directly from the emergency department
after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required
blood pressure lowering medications. These episodes cannot be explained on the basis of the
pharmacological property of either drug or the subjects' medical histories. The investigator would
submit an SAE report to the Sponsor for:
A. Neither of the subjects
B. Subject 603 only
C. Subject 20 only
D. Both of the subjects - ANSWER-D. Both of the subjects
During the course of administration of an investigational drug, the following events occurred: On Day 7,
subject 603 has an unexpected stroke that requires hospitalization. On Day 15, subject 415 complains of
nausea, vomiting, and headache relieved by aspirin. On Day 21, subject 20 has brief dizzy spells upon
trying to stand. An IND Safety Report is most likely filed by the sponsor with the FDA for the
observations associated with
A. Subject 603 only
B. None of the subjects
C. All three of the subjects
D. Subject 20 only - ANSWER-A. Subject 603 only
Subject 311 has had elevated white blood cell (WBC) counts for the past 2 study visits, with no clinical
signs or symptoms. "Increased WBC count" is not listed in the Investigator's Brochure (IB) as an adverse
event. The investigator should:
A. Immediately fax a handwritten SAE report to the FDA.
B. Report the elevated WBC to the sponsor as an unexpected adverse effect
C. Repeat the laboratory tests until they return to normal before reporting
,D. Hospitalize subject for transfusion - ANSWER-B. Report the elevated WBC to the sponsor as an
unexpected adverse effect
When does an IND Safety Report have to be reported to the FDA within 15 calendar days?
A. When the event is serious, unexpected and thought to be caused by the study agent
B. When the event is unexpected and fatal or life threatening
C. When the event is serious and unexpected
D. When the event is listed in the Investigator Brochure - ANSWER-A. When the event is serious,
unexpected and thought to be caused by the study agent
An Adverse Reaction is:
A. Any untoward medical occurrence associated with the use of a drug in humans
B. Any adverse event caused by a drug
C. Any adverse reaction for which there is a reasonable possibility that the drug caused the event
D. Any adverse event that is unexpected - ANSWER-B. Any adverse event caused by a drug
The primary document used in determining whether an event is expected is:
A. The protocol
B. The consent form
C. The Investigator Brochure
D. The lab manual - ANSWER-C. The Investigator Brochure
Who determines if an event is serious?
A. Investigator
B. Sponsor
C. Monitor
D. Either the Investigator or the Sponsor - ANSWER-D. Either the Investigator or the Sponsor
An investigator must submit to the sponsor and the reviewing IRB a report of any unanticipated adverse
device effect no later than:
, A. 7 working days
B. 10 working days
C. 7 calendar days
D. 10 calendar days - ANSWER-B. 10 working days
A Serious Adverse Event or Reaction is any untoward medical occurrence at any dose that:
A. Results in death, is life threatening, requires inpatient hospitalization or prolongation of existing
hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth
defect.
B. Results in death, is life threatening, requires inpatient hospitalization or prolongation of existing
hospitalization, or is a congenital anomaly/birth defect.
C. Results in death, is life threatening, results in persistent or significant disability/incapacity or is a
congenital anomaly/birth defect.
D. Results in death, is life threatening, requires inpatient hospitalization or prolongation of existing
hospitalization, or results in persistent or significant disability/incapacity. - ANSWER-A. Results in death,
is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
A serious, unexpected Adverse Drug Reaction must be submitted to the FDA within:
A. 7 calendar days
B. 10 working days
C. 15 working days
D. 15 calendar days - ANSWER-D. 15 calendar days
An adverse event for which there is a reasonable possibility that the drug caused the event is
A. Adverse event
B. Adverse Reaction
C. Adverse Drug Reaction
D. Suspected Adverse Reaction - ANSWER-D. Suspected Adverse Reaction
Who determines if an adverse event or suspected adverse reaction is unexpected?
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