BCMAS EXAM QUESTIONS AND ANSWERS
Clinical trials designed to meet regulatory approval criteria are conducted to do all of the
following. Choose all that apply
-guarantee that the drug/device is tolerated, safe, and effective
-ensure the safety and efficacy of a medical strategy
-explore how a drug or device interacts with the physiology of the human body
Which type of study can determine a cause-effect relationship?
Randomized controlled trials
A Pharma company is looking to begin the development of a new drug. Why would the
company consult an advisory board?
To provide their opinion on the research and development of the drug
TRUE/FALSE Standard Response Documents (SRDs) are prepared only for HCPs in
response to questions about product(s)
FALSE
What type of FDA-mandated studies are most common? Select the best answer
Randomized Controlled Trials (RCTs)
Dr. Simpson, a neurologist, occasionally participates on an advisory board for Lightning
Pharmaceuticals. Dr. Simpson has also just become a member of a national committee
that makes recommendations for clinical guidelines and formulary decisions. Is Dr.
Simpson required to disclose her relationship with Lightning Pharmaceuticals to the
national committee she is a member of?
Yes, it would be unethical and potentially a conflict of interest if she does not disclose
the relationship
TRUE/FALSE Post-Marketing studies are only conducted on newly-approved drugs.
FALSE
Clinical trials designed to meet regulatory approval criteria are conducted to do all of the
following. Choose all that apply
-guarantee that the drug/device is tolerated, safe, and effective
-ensure the safety and efficacy of a medical strategy
-explore how a drug or device interacts with the physiology of the human body
Which type of study can determine a cause-effect relationship?
Randomized controlled trials
A Pharma company is looking to begin the development of a new drug. Why would the
company consult an advisory board?
To provide their opinion on the research and development of the drug
TRUE/FALSE Standard Response Documents (SRDs) are prepared only for HCPs in
response to questions about product(s)
FALSE
What type of FDA-mandated studies are most common? Select the best answer
Randomized Controlled Trials (RCTs)
Dr. Simpson, a neurologist, occasionally participates on an advisory board for Lightning
Pharmaceuticals. Dr. Simpson has also just become a member of a national committee
that makes recommendations for clinical guidelines and formulary decisions. Is Dr.
Simpson required to disclose her relationship with Lightning Pharmaceuticals to the
national committee she is a member of?
Yes, it would be unethical and potentially a conflict of interest if she does not disclose
the relationship
TRUE/FALSE Post-Marketing studies are only conducted on newly-approved drugs.
FALSE
