CITI - GCP
`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? - ANS - 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: - ANS - 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: - ANS - Both of the subjects
A primary purpose of the ICH is to: - ANS - 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? - ANS - 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? - ANS
- Principal Investigator
According to ICH E6, an "audit" is defined as: - ANS - A systematic and independent
examination of trial-related activities and documents.
, According to ICH E6, an inspection is defined as: - ANS - 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: - ANS - Ensuring subject
safety.
An investigator conducting a study of a medical device under an IDE is required to
complete and sign which of the following? - ANS - An investigator's agreement
An investigator is confronted with a life-threatening situation that necessitates using a
test article in a human subject who is unable to provide informed consent and there is
no time to obtain consent for the individual's legal representative. Under the FDA
regulations, which of the following describes the best course of action for the
investigator: - ANS - The investigator and another physician not part of the study team
agree that the situation necessitates the use of the test article and the IRB will be
notified later.
At which study visits can the site expect the sponsor to review subjects' signed informed
consent forms? - ANS - Periodic and termination site visits
Development of most new drugs, from discovery to marketing approval, usually takes: -
ANS - 9 or more years
During the course of administration of an investigational drug, the following events
occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization;
On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by
aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of
these subject's events meets the FDA definition of "serious" and "unexpected" and
would require the sponsor to file an IND Safety Report with the FDA? - ANS - Subject
603 only
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the
FDA by the: - ANS - Sponsor
For a Phase I new drug study in humans, what is the primary source of the data
included in the initial Investigator's Brochure? - ANS - Preclinical data
Form FDA 1572, Statement of Investigator, is legally binding between the investigator
and the: - ANS - FDA
`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? - ANS - 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: - ANS - 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: - ANS - Both of the subjects
A primary purpose of the ICH is to: - ANS - 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? - ANS - 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? - ANS
- Principal Investigator
According to ICH E6, an "audit" is defined as: - ANS - A systematic and independent
examination of trial-related activities and documents.
, According to ICH E6, an inspection is defined as: - ANS - 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: - ANS - Ensuring subject
safety.
An investigator conducting a study of a medical device under an IDE is required to
complete and sign which of the following? - ANS - An investigator's agreement
An investigator is confronted with a life-threatening situation that necessitates using a
test article in a human subject who is unable to provide informed consent and there is
no time to obtain consent for the individual's legal representative. Under the FDA
regulations, which of the following describes the best course of action for the
investigator: - ANS - The investigator and another physician not part of the study team
agree that the situation necessitates the use of the test article and the IRB will be
notified later.
At which study visits can the site expect the sponsor to review subjects' signed informed
consent forms? - ANS - Periodic and termination site visits
Development of most new drugs, from discovery to marketing approval, usually takes: -
ANS - 9 or more years
During the course of administration of an investigational drug, the following events
occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization;
On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by
aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of
these subject's events meets the FDA definition of "serious" and "unexpected" and
would require the sponsor to file an IND Safety Report with the FDA? - ANS - Subject
603 only
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the
FDA by the: - ANS - Sponsor
For a Phase I new drug study in humans, what is the primary source of the data
included in the initial Investigator's Brochure? - ANS - Preclinical data
Form FDA 1572, Statement of Investigator, is legally binding between the investigator
and the: - ANS - FDA
