Good Clinical Practice (GCP)
1. 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 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 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 GCP, an "Audit" is defined as: - ANS - A systematic and
independent examination of trial-related activities and documents.
According to ICH E6 GCP, 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.
Adults with more than a 12-month history of migraines were assigned randomly in a
double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or
placebo. The primary efficacy measure was the reduction in severity of the migraine
attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical
phase of this study? - ANS - Phase III
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 from 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 who is 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 years or more
During the course of administration of an investigational drug, the following events
occur: 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: -
ANS - Subject 603 only
1. 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 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 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 GCP, an "Audit" is defined as: - ANS - A systematic and
independent examination of trial-related activities and documents.
According to ICH E6 GCP, 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.
Adults with more than a 12-month history of migraines were assigned randomly in a
double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or
placebo. The primary efficacy measure was the reduction in severity of the migraine
attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical
phase of this study? - ANS - Phase III
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 from 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 who is 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 years or more
During the course of administration of an investigational drug, the following events
occur: 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: -
ANS - Subject 603 only
