Good Clinical Practice
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.
* Informed consent is not a one-time procedure but a continuing and ongoing process.
45 CFR 116(b) and 21 CFR 50.25(b) requires that the informed consent document
include a statement indicating that if significant new findings are developed during
research which may relate to the subject's willingness to continue they will be explained
to the subject. The informed consent document must also describe the process whereby
subjects will be notified of significant new findings.
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 510(k) Premarket Notification is submitted when a manufacturer wishes to market a
qualified medical device in the U.S. without conducting clinical trials. To do so, the
manufacturer must demonstrate to FDA that the device is equivalent to one already
marketed. An IDE must be submitted when clinical trials of investigational devices are
needed to determine the safety and effectiveness of a new device or when studying
substantial modifications to or new intended uses for devices already on the market. A
Premarket Approval (PMA) might be submitted for the FDA to evaluate the results of a
completed clinical trial of a Class III device.
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
, * While subject 603 was admitted and discharged from the emergency department
which is not considered meeting the SAE criteria of a hospitalization, the life-threatening
nature of the symptoms does meet SAE criteria. Subject 20 was hospitalized which is
reportable as an SAE.
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.
* The broken wrist and mild concussion are changes from the subject's baseline and are
unexpected and untoward medical occurrences and therefore reportable as adverse
events. The motor vehicle crash is the cause of the adverse events, not the adverse
event itself.
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
* Determining the relationship of the investigational agent to an adverse event requires
medical decision making and expertise. The person making this determination should
be medically qualified to do so. The Principal Investigator of the Phase I study is
responsible for assessing and reporting adverse events.
According to ICH E6, an "audit" is defined as: - ANS - A systematic and independent
examination of trial-related activities and documents.
* A systematic and independent examination of trial-related activities and documents is
"an audit" and the act of overseeing the progress of a clinical trial is "monitoring." An
inspection is defined as the act by a regulatory authority(ies) of conducting an official
review of documents, facilities, records, and any other resources related to a clinical
trial.
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.
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.
* Informed consent is not a one-time procedure but a continuing and ongoing process.
45 CFR 116(b) and 21 CFR 50.25(b) requires that the informed consent document
include a statement indicating that if significant new findings are developed during
research which may relate to the subject's willingness to continue they will be explained
to the subject. The informed consent document must also describe the process whereby
subjects will be notified of significant new findings.
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 510(k) Premarket Notification is submitted when a manufacturer wishes to market a
qualified medical device in the U.S. without conducting clinical trials. To do so, the
manufacturer must demonstrate to FDA that the device is equivalent to one already
marketed. An IDE must be submitted when clinical trials of investigational devices are
needed to determine the safety and effectiveness of a new device or when studying
substantial modifications to or new intended uses for devices already on the market. A
Premarket Approval (PMA) might be submitted for the FDA to evaluate the results of a
completed clinical trial of a Class III device.
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
, * While subject 603 was admitted and discharged from the emergency department
which is not considered meeting the SAE criteria of a hospitalization, the life-threatening
nature of the symptoms does meet SAE criteria. Subject 20 was hospitalized which is
reportable as an SAE.
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.
* The broken wrist and mild concussion are changes from the subject's baseline and are
unexpected and untoward medical occurrences and therefore reportable as adverse
events. The motor vehicle crash is the cause of the adverse events, not the adverse
event itself.
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
* Determining the relationship of the investigational agent to an adverse event requires
medical decision making and expertise. The person making this determination should
be medically qualified to do so. The Principal Investigator of the Phase I study is
responsible for assessing and reporting adverse events.
According to ICH E6, an "audit" is defined as: - ANS - A systematic and independent
examination of trial-related activities and documents.
* A systematic and independent examination of trial-related activities and documents is
"an audit" and the act of overseeing the progress of a clinical trial is "monitoring." An
inspection is defined as the act by a regulatory authority(ies) of conducting an official
review of documents, facilities, records, and any other resources related to a clinical
trial.
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.
