CITI TRAINING - GOOD
CLINICAL PRACTICE
Where is information on storage requirements for the investigational
product usually found? - ANSWERS-In the study protocol
Overview of U.S. FDA Regulations for Medical Devices -
ANSWERS-
An investigator conducting a study of a medical device under an IDE
is required to complete and sign which of the following? -
ANSWERS-An investigator's agreement
A 510(k) Premarket Notification is submitted: - ANSWERS-When the
new device to be marketed is substantially similar (equivalent) to one
already on the market
Evaluation of Unanticipated Adverse Device Effects (UADEs) must
be reported to the FDA by the: - ANSWERS-Sponsor
Detecting and Evaluating Adverse Events - ANSWERS-
When evaluating the causality of an adverse event, which of the
following should be a consideration? - ANSWERS-The timing of the
event in relation to administration of the investigational agent
, Accurate reporting of adverse events is most important for: -
ANSWERS-Ensuring subject safety.
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? - ANSWERS-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? - ANSWERS-Principal Investigator
Reporting Serious Adverse Events - ANSWERS-
The sponsor must submit an IND Safety Report to the FDA if an
adverse event is (1) serious; (2) unexpected; and: - ANSWERS-(3)
there is a reasonable possibility that the drug caused the event.
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
CLINICAL PRACTICE
Where is information on storage requirements for the investigational
product usually found? - ANSWERS-In the study protocol
Overview of U.S. FDA Regulations for Medical Devices -
ANSWERS-
An investigator conducting a study of a medical device under an IDE
is required to complete and sign which of the following? -
ANSWERS-An investigator's agreement
A 510(k) Premarket Notification is submitted: - ANSWERS-When the
new device to be marketed is substantially similar (equivalent) to one
already on the market
Evaluation of Unanticipated Adverse Device Effects (UADEs) must
be reported to the FDA by the: - ANSWERS-Sponsor
Detecting and Evaluating Adverse Events - ANSWERS-
When evaluating the causality of an adverse event, which of the
following should be a consideration? - ANSWERS-The timing of the
event in relation to administration of the investigational agent
, Accurate reporting of adverse events is most important for: -
ANSWERS-Ensuring subject safety.
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? - ANSWERS-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? - ANSWERS-Principal Investigator
Reporting Serious Adverse Events - ANSWERS-
The sponsor must submit an IND Safety Report to the FDA if an
adverse event is (1) serious; (2) unexpected; and: - ANSWERS-(3)
there is a reasonable possibility that the drug caused the event.
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
