A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy.
While the study is ongoing, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - ✖◻✖◻Discuss the pros and
cons of both the investigational drug and the commercially available drug and then allow the subject to
decide whether to withdraw from the research to take the new drug.
A 510(k) Premarket Notification is submitted: - ✖◻✖◻When the new device to be marketed is
substantially similar (equivalent) to one already on the market
A double-blinded trial for a new indication is conducted under an IND comparing two (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 for: - ✖◻✖◻Both of the subjects
A primary purpose of the ICH is to: - ✖◻✖◻Minimize the need for redundant research.
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? - ✖◻✖◻Report
adverse events of both a broken wrist and a mild concussion.
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 I study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event? - ✖◻✖◻Principal Investigator
According to ICH E6, an "audit" is defined as: - ✖◻✖◻A systematic and independent examination of
trial-related activities and documents.
According to ICH E6, an inspection is defined as: - ✖◻✖◻An official review of documents, facilities,
, records, and any other resources related to a clinical trial.
Accurate reporting of adverse events is most important for: - ✖◻✖◻Ensuring subject safety.
While the study is ongoing, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - ✖◻✖◻Discuss the pros and
cons of both the investigational drug and the commercially available drug and then allow the subject to
decide whether to withdraw from the research to take the new drug.
A 510(k) Premarket Notification is submitted: - ✖◻✖◻When the new device to be marketed is
substantially similar (equivalent) to one already on the market
A double-blinded trial for a new indication is conducted under an IND comparing two (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 for: - ✖◻✖◻Both of the subjects
A primary purpose of the ICH is to: - ✖◻✖◻Minimize the need for redundant research.
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? - ✖◻✖◻Report
adverse events of both a broken wrist and a mild concussion.
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 I study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event? - ✖◻✖◻Principal Investigator
According to ICH E6, an "audit" is defined as: - ✖◻✖◻A systematic and independent examination of
trial-related activities and documents.
According to ICH E6, an inspection is defined as: - ✖◻✖◻An official review of documents, facilities,
, records, and any other resources related to a clinical trial.
Accurate reporting of adverse events is most important for: - ✖◻✖◻Ensuring subject safety.
