BCMAS QUESTIONS AND ANSWERS
What are some of the reasons for conducting Post-Marketing studies? Select all that
apply
-To support drug development
-As a condition for a drug's approval
-For supplemental data on Phase III Trials
Which of the following traits do individuals with strong EI possess? Select all that apply.
-have a robust vocabulary
-do not hold grudges
-are a good judge of character
Which one is an example of an IVD that is used to determine the presence/absence or
sensitivity of microorganisms in a sample from a human body?
Microbiology culture
What is a mobile medical application?
A mobile app that is intended to be used as an accessory to a regulated medical device.
The medical affairs team develops the clinical protocol for the study.
TRUE
TRUE/FALSE Administrative supplement grants are requests for additional funds either
for the current operating year or any future year to cover increased costs or expand the
scope of work.
TRUE
A phase III study is conducted to evaluate the efficacy and safety of an investigational
blood pressure medication osamarin compared with losartan, a drug already on the
market. There were 1,000 patients randomized with 500 participants in the osamarin
group and 500 in the losartan group. What type of study is this considered?
Randomized controlled trial
What are some of the reasons for conducting Post-Marketing studies? Select all that
apply
-To support drug development
-As a condition for a drug's approval
-For supplemental data on Phase III Trials
Which of the following traits do individuals with strong EI possess? Select all that apply.
-have a robust vocabulary
-do not hold grudges
-are a good judge of character
Which one is an example of an IVD that is used to determine the presence/absence or
sensitivity of microorganisms in a sample from a human body?
Microbiology culture
What is a mobile medical application?
A mobile app that is intended to be used as an accessory to a regulated medical device.
The medical affairs team develops the clinical protocol for the study.
TRUE
TRUE/FALSE Administrative supplement grants are requests for additional funds either
for the current operating year or any future year to cover increased costs or expand the
scope of work.
TRUE
A phase III study is conducted to evaluate the efficacy and safety of an investigational
blood pressure medication osamarin compared with losartan, a drug already on the
market. There were 1,000 patients randomized with 500 participants in the osamarin
group and 500 in the losartan group. What type of study is this considered?
Randomized controlled trial
