Good Clinical Practice Course (Medical
Clinical Research)
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?
a. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
b. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients
c. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed
d. 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. - ANS - d. 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:
a. When clinical trials of a Class III device are completed
b. When the new device to be marketed is substantially similar (equivalent) to one
already on the market
c. Before any clinical trials of an investigational device can begin
d. When no alternative treatment exists for a life-threatening condition - ANS - b.
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:
, a. Neither of the subjects
b. Subject 603 only
c. Both of the subjects
d. Subject 20 only - ANS - c. Both of the subjects
A primary purpose of the ICH is to:
a. Require FDA registration of worldwide clinical trials.
b. Minimize the need for redundant research.
c. Require publication of negative trial results.
d. Develop mandatory worldwide regulations for drug development. - ANS - b.
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?
a. No report is needed because the subject was a passenger in the vehicle and not
driving.
b. Report adverse events of both a broken wrist and a mild concussion.
c. Report only the concussion because it might become serious.
d. No report is needed because these are not serious adverse events. - ANS - b.
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?
a. Principal Investigator
b. ED nurse
c. Pharmacist
d. Study Coordinator - ANS - a. Principal Investigator
According to ICH E6, an "audit" is defined as:
a. The act of overseeing the progress of a clinical trial.
b. An official review of documents, facilities, records, and any other resources related to
a clinical trial.
c. A systematic and independent examination of trial-related activities and documents.
d. An institutional self-assessment. - ANS - c. A systematic and independent
examination of trial-related activities and documents.
Clinical Research)
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?
a. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
b. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients
c. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed
d. 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. - ANS - d. 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:
a. When clinical trials of a Class III device are completed
b. When the new device to be marketed is substantially similar (equivalent) to one
already on the market
c. Before any clinical trials of an investigational device can begin
d. When no alternative treatment exists for a life-threatening condition - ANS - b.
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:
, a. Neither of the subjects
b. Subject 603 only
c. Both of the subjects
d. Subject 20 only - ANS - c. Both of the subjects
A primary purpose of the ICH is to:
a. Require FDA registration of worldwide clinical trials.
b. Minimize the need for redundant research.
c. Require publication of negative trial results.
d. Develop mandatory worldwide regulations for drug development. - ANS - b.
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?
a. No report is needed because the subject was a passenger in the vehicle and not
driving.
b. Report adverse events of both a broken wrist and a mild concussion.
c. Report only the concussion because it might become serious.
d. No report is needed because these are not serious adverse events. - ANS - b.
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?
a. Principal Investigator
b. ED nurse
c. Pharmacist
d. Study Coordinator - ANS - a. Principal Investigator
According to ICH E6, an "audit" is defined as:
a. The act of overseeing the progress of a clinical trial.
b. An official review of documents, facilities, records, and any other resources related to
a clinical trial.
c. A systematic and independent examination of trial-related activities and documents.
d. An institutional self-assessment. - ANS - c. A systematic and independent
examination of trial-related activities and documents.
