BCMAS MAIN EXAMINATION 2026 SET QUESTIONS
AND ANSWERS SURE A+
✔✔True or False: Adverse event reports may be carried out through medical registries.
True
False - ✔✔True
✔✔True or False: Adverse event reports may be carried out through medical registries.
True
False - ✔✔True
✔✔Which of the following statement(s) is/are true? (Select all that apply)
The Quality system in the US for devices is not identical to that of pharmaceuticals
(Good Manufacturing Practices - GMPs).
The basic quality system requirements for drug and drug products is the same as for
devices.
Quality Systems are required to be in place for the US for medical devices as well as
pharmaceuticals. - ✔✔The Quality system in the US for devices is not identical to that of
pharmaceuticals (Good Manufacturing Practices - GMPs).
Quality Systems are required to be in place for the US for medical devices as well as
pharmaceuticals.
✔✔Second tier compliance includes (Select all that apply)
Protection of Human Subjects
Good Laboratory Practice
IRB
GMP
Criminal violations - ✔✔Protection of Human Subjects
Good Laboratory Practice
IRB
✔✔Which of the following is NOT a limitation of meta-analysis?
It is a qualitative summary of results
Accumulation of biases
Limited by the quality of the studies included
Errors in original work cannot be checked - ✔✔It is a qualitative summary of results
✔✔True or False: An MSL can proactively discuss information with an HCP as long as it
relates to the PI only.
,True
False - ✔✔True
✔✔Which of the following statements regarding reimbursement is true:
As long as the surgeon decides on a device for his patient, he will get it.
As long as marketing can create an excellent animation of the device's benefits, CMS
can set appropriate benefit-value reimbursement levels.
Only large manufacturers need to set reimbursement strategies.
None are true. - ✔✔None are true.
✔✔PMR stands for:
Postmarketing rollout
Postmarketing revelance
Postmarketing research
Postmarketing requirements - ✔✔Postmarketing requirements
✔✔When is a cost-utility analysis (CUA) used?
When outcomes of each treatment are measured in nonmonetary units
When all outcomes are measured in monetary units
When all outcomes are expected to be equal
When patient preferences for alternative treatments are being considered - ✔✔When
patient preferences for alternative treatments are being considered
✔✔True or False: An MSL may invite an HCP to dinner to reactively discuss a newly
marketed drug.
True
False - ✔✔True
✔✔The role of Medical Affairs in postmarketing research is to (Select all that apply):
Ensure that the drug is safe for public use
Put together an advisory board
Create a strategy for phase IV studies
Inform health care professionals about new changes in labeling
Provide information on off-label uses - ✔✔Create a strategy for phase IV studies
Inform health care professionals about new changes in labeling
Provide information on off-label uses
✔✔An API is produced by companies that:
Produce drugs under license from other companies
Produce raw materials
, Sell off-patented drugs
Design and sell patented drugs - ✔✔Produce raw materials
✔✔True or False: RCT is the best experimental design to provide the most reliable
information and data.
True
False - ✔✔True
✔✔The investigator needs to present the following in a grant proposal (Select all that
apply):
Understanding of regulations by noting all relevant regulations
Budget
Curriculum vitae
Protocol
An explanation of the discovery process of the drug
Name of the MSL who suggested the study, if any - ✔✔Budget
Curriculum vitae
Protocol
✔✔One of the purposes of phase IV studies is:
Pricing negotiations
Determining superiority over the gold-standard
Creating the PI of the drug
Outlining toxicity of the drug - ✔✔Pricing negotiations
✔✔An example of secondary sources of information include:
Internet sources
Dissertations
Drug compendia
Review articles - ✔✔Review articles
✔✔Good Laboratory Practices are defined by regulations in the Code of Federal
Regulations. Which of the responses below are NOT correct?
There is a need for a formally approved protocol for GLP studies.
GLPs are applied to in vitro and in vivo preclinical safety studies.
There is the requirement of oversite by an IRB.
All choices are correct responses - ✔✔There is the requirement of oversite by an IRB
✔✔A new drug that targets serious condition and unmet medical need can apply for this
expedited process for approval:
AND ANSWERS SURE A+
✔✔True or False: Adverse event reports may be carried out through medical registries.
True
False - ✔✔True
✔✔True or False: Adverse event reports may be carried out through medical registries.
True
False - ✔✔True
✔✔Which of the following statement(s) is/are true? (Select all that apply)
The Quality system in the US for devices is not identical to that of pharmaceuticals
(Good Manufacturing Practices - GMPs).
The basic quality system requirements for drug and drug products is the same as for
devices.
Quality Systems are required to be in place for the US for medical devices as well as
pharmaceuticals. - ✔✔The Quality system in the US for devices is not identical to that of
pharmaceuticals (Good Manufacturing Practices - GMPs).
Quality Systems are required to be in place for the US for medical devices as well as
pharmaceuticals.
✔✔Second tier compliance includes (Select all that apply)
Protection of Human Subjects
Good Laboratory Practice
IRB
GMP
Criminal violations - ✔✔Protection of Human Subjects
Good Laboratory Practice
IRB
✔✔Which of the following is NOT a limitation of meta-analysis?
It is a qualitative summary of results
Accumulation of biases
Limited by the quality of the studies included
Errors in original work cannot be checked - ✔✔It is a qualitative summary of results
✔✔True or False: An MSL can proactively discuss information with an HCP as long as it
relates to the PI only.
,True
False - ✔✔True
✔✔Which of the following statements regarding reimbursement is true:
As long as the surgeon decides on a device for his patient, he will get it.
As long as marketing can create an excellent animation of the device's benefits, CMS
can set appropriate benefit-value reimbursement levels.
Only large manufacturers need to set reimbursement strategies.
None are true. - ✔✔None are true.
✔✔PMR stands for:
Postmarketing rollout
Postmarketing revelance
Postmarketing research
Postmarketing requirements - ✔✔Postmarketing requirements
✔✔When is a cost-utility analysis (CUA) used?
When outcomes of each treatment are measured in nonmonetary units
When all outcomes are measured in monetary units
When all outcomes are expected to be equal
When patient preferences for alternative treatments are being considered - ✔✔When
patient preferences for alternative treatments are being considered
✔✔True or False: An MSL may invite an HCP to dinner to reactively discuss a newly
marketed drug.
True
False - ✔✔True
✔✔The role of Medical Affairs in postmarketing research is to (Select all that apply):
Ensure that the drug is safe for public use
Put together an advisory board
Create a strategy for phase IV studies
Inform health care professionals about new changes in labeling
Provide information on off-label uses - ✔✔Create a strategy for phase IV studies
Inform health care professionals about new changes in labeling
Provide information on off-label uses
✔✔An API is produced by companies that:
Produce drugs under license from other companies
Produce raw materials
, Sell off-patented drugs
Design and sell patented drugs - ✔✔Produce raw materials
✔✔True or False: RCT is the best experimental design to provide the most reliable
information and data.
True
False - ✔✔True
✔✔The investigator needs to present the following in a grant proposal (Select all that
apply):
Understanding of regulations by noting all relevant regulations
Budget
Curriculum vitae
Protocol
An explanation of the discovery process of the drug
Name of the MSL who suggested the study, if any - ✔✔Budget
Curriculum vitae
Protocol
✔✔One of the purposes of phase IV studies is:
Pricing negotiations
Determining superiority over the gold-standard
Creating the PI of the drug
Outlining toxicity of the drug - ✔✔Pricing negotiations
✔✔An example of secondary sources of information include:
Internet sources
Dissertations
Drug compendia
Review articles - ✔✔Review articles
✔✔Good Laboratory Practices are defined by regulations in the Code of Federal
Regulations. Which of the responses below are NOT correct?
There is a need for a formally approved protocol for GLP studies.
GLPs are applied to in vitro and in vivo preclinical safety studies.
There is the requirement of oversite by an IRB.
All choices are correct responses - ✔✔There is the requirement of oversite by an IRB
✔✔A new drug that targets serious condition and unmet medical need can apply for this
expedited process for approval:
