FDA-Regulated Research Test Questions and Answers
A sponsor proposes research to evaluate records and electronic signatures (21 CFR
reengineering a commercially available Part 11) is intended to: - ANSWER -
pacemaker. It is hoped that the new Allow the use of electronic documents and
pacemaker will pose fewer risks to signatures in the regulatory process for drugs
individuals when compared to the current and devices.
commercially available product. How should
this device be classified? - ANSWER -
Significant risk device An academic medical center is selecting a
new database system for clinical research.
The system needs to be "Part 11 compliant" in
An adult with attention deficit hyperactivity order to allow: - ANSWER -The medical
disorder (ADHD) presents to a physician. To center to replace the use of paper records
date, no behavioral or drug interventions with electronic records for its research.
have proven useful. The physician has just
read several reports about a drug that is
approved and marketed for another
indication, but has shown some benefit for
ADHD. The physician wants to prescribe this
drug, in the labeled marketed dose, for the
individual patient. Which of the following
would be the most appropriate course of
action? - ANSWER -Treat the patient
with the drug based on physician's best
medical judgment
An investigator proposes to study a marketed
product sold to treat high blood pressure in
individuals over age 12 using a liquid
formulation for children under age 12. The
drug sponsor hopes that the information from
the research can be used to change the
labeling for use of the drug in younger
children. Which of the following is the
investigator's most appropriate course of
action? - ANSWER -Submit the
research protocol to the IRB for review and
submit an IND application to the FDA before
conducting the research
The FDA's regulations related to electronic
1/1
A sponsor proposes research to evaluate records and electronic signatures (21 CFR
reengineering a commercially available Part 11) is intended to: - ANSWER -
pacemaker. It is hoped that the new Allow the use of electronic documents and
pacemaker will pose fewer risks to signatures in the regulatory process for drugs
individuals when compared to the current and devices.
commercially available product. How should
this device be classified? - ANSWER -
Significant risk device An academic medical center is selecting a
new database system for clinical research.
The system needs to be "Part 11 compliant" in
An adult with attention deficit hyperactivity order to allow: - ANSWER -The medical
disorder (ADHD) presents to a physician. To center to replace the use of paper records
date, no behavioral or drug interventions with electronic records for its research.
have proven useful. The physician has just
read several reports about a drug that is
approved and marketed for another
indication, but has shown some benefit for
ADHD. The physician wants to prescribe this
drug, in the labeled marketed dose, for the
individual patient. Which of the following
would be the most appropriate course of
action? - ANSWER -Treat the patient
with the drug based on physician's best
medical judgment
An investigator proposes to study a marketed
product sold to treat high blood pressure in
individuals over age 12 using a liquid
formulation for children under age 12. The
drug sponsor hopes that the information from
the research can be used to change the
labeling for use of the drug in younger
children. Which of the following is the
investigator's most appropriate course of
action? - ANSWER -Submit the
research protocol to the IRB for review and
submit an IND application to the FDA before
conducting the research
The FDA's regulations related to electronic
1/1
