BCMAS 2026 STUDY GUIDE TEST QUESTIONS AND
ANSWERS SURE A+
✔✔Which type of abstract is characterized by having results and conclusion:
Descriptive
Regulatory
Commercial
Informative - ✔✔Informative
✔✔What are some of the core responsibilities of an MSL? (Select all that apply)
Communicating interest in ISS
Medical writing
Networking and identifying potential KOLs
Conducting market research
Developing slide kits for presentations
Understanding regulatory issues that may increase corporate risk
No choices are correct - ✔✔Communicating interest in ISS
Medical writing
Networking and identifying potential KOLs
Conducting market research
Developing slide kits for presentations
Understanding regulatory issues that may increase corporate risk
✔✔True or False: It is considered appropriate for company representatives to offer
meals as a business courtesy to HCPs and their family members.
True
False - ✔✔False
✔✔Some of the risks REMS aim to mitigate include: (select all that apply)
Serious Infection
Liver damage
Severe birth defects
Severe allergic reaction - ✔✔Serious Infection
Liver damage
Severe birth defects
Severe allergic reaction
✔✔The ultimate objective of a medical brand strategy is advancing:
Clinical Practice
Medical science
,Patient Outcomes
All of these are true - ✔✔All of these are true
✔✔Labeling for the prescribing information takes place:
After an NDA is approved
Before an IND is filed
During post-market research
After the FDA determines that the drug is safe and effective - ✔✔After the FDA
determines that the drug is safe and effective
✔✔Payments to external authors are permissible as long as the following criteria are
met:
The author states his/her conflict of interest on the final manuscript.
The author has had a long standing relationship with the pharmaceutical company.
The author is writing a review article that is promotional in nature.
The author is close friends with the CEO of the pharmaceutical company. - ✔✔The
author is writing a review article that is promotional in nature.
✔✔The stage at which experiments are conducted on humans is during:
Discovery phase
Labeling process
Clinical trials
Pre-clinical trials - ✔✔Clinical trials
✔✔Equivalence studies are conducted when
The researcher wants to examine whether the treatment is similar to a control
Sampling from a target population is difficult
It is unethical to provide one group with the treatment
The researcher wants to test whether the effect of a new drug is not statistically
significant from the effect of a standard one - ✔✔The researcher wants to examine
whether the treatment is similar to a control
✔✔Identify the type of document or application submitted for marketing a vaccine:
BLA
IND
ANDA
NDA - ✔✔BLA
✔✔Procedures for performance standards development can be found under
,Sections 21 CFR 861
SOR/98-282
CFR 807 Subpart E
Section 510(k) - ✔✔Sections 21 CFR 861
✔✔True or False: Medical Information typically creates SRDs for products within the
company's pipeline in response to questions.
True
False - ✔✔True
✔✔Choose the correct answer about medical writing:
ICH guidelines are important in Regulatory Writing
Medical writing does not require good literature research skills
Medical writing is only valued within Medical Affairs - ✔✔ICH guidelines are important in
Regulatory Writing
✔✔True or False: Cohort studies and RCTs are both considered experimental studies
True
False - ✔✔False
✔✔Which of the following is NOT a tier of KOL identification?
Regional
Local
District
National - ✔✔District
✔✔According to the PhRMA Code, which of the following is an appropriate item for a
company to offer to a non-faculty HCP?
A $25 gift card for attending a company-sponsored CME program
A $40-worth anatomical model of the heart to be used in the office to educate patients
on heart failure
A stapler with the logo of company's new diabetes drug accompanied by patient
educational pamphlets
Tickets to a local baseball game - ✔✔A $40-worth anatomical model of the heart to be
used in the office to educate patients on heart failure
✔✔True or False: Medical Information reviews both promotional and non-promotional
materials in the scientific review committee.
True
, False - ✔✔True
✔✔Superiority trials are conducted when:
The researcher wants to test whether the effect of a new drug is better than the effect of
a standard one
The researcher wants to examine whether the treatment is similar to a control
It is unethical to provide one group with the treatment
Sampling from a target population is difficult - ✔✔The researcher wants to test whether
the effect of a new drug is better than the effect of a standard one
✔✔Time-dependent reactions include: (Select all that apply)
Delayed reactions that can occur after the drug has been discontinued
Reaction that only occurs after the first dose
Reactions that occur early in treatment
Due to administering two or more drugs at the same time
Reactions when a drug is administered too quickly
Reaction due to the patient's age - ✔✔Delayed reactions that can occur after the drug
has been discontinued
Reaction that only occurs after the first dose
Reactions that occur early in treatment
Reactions when a drug is administered too quickly
✔✔Identify the phase during which an IND is submitted:
Before clinical trials
After clinical trials
After the drug discovery process
Before pre-clinical trials - ✔✔Before clinical trials
✔✔The conclusion section should include (Select all that apply):
Significance of the study
Implications
Interpretation of p-values
Important Numerical findings
A summary of the study and its purpose - ✔✔Significance of the study
Implications
✔✔Discounting is a term that describes:
The discount of present costs based on future values
The discount a healthcare provider (HCP) gets when purchasing a certain device
The discount of future costs adjustments based on present values
ANSWERS SURE A+
✔✔Which type of abstract is characterized by having results and conclusion:
Descriptive
Regulatory
Commercial
Informative - ✔✔Informative
✔✔What are some of the core responsibilities of an MSL? (Select all that apply)
Communicating interest in ISS
Medical writing
Networking and identifying potential KOLs
Conducting market research
Developing slide kits for presentations
Understanding regulatory issues that may increase corporate risk
No choices are correct - ✔✔Communicating interest in ISS
Medical writing
Networking and identifying potential KOLs
Conducting market research
Developing slide kits for presentations
Understanding regulatory issues that may increase corporate risk
✔✔True or False: It is considered appropriate for company representatives to offer
meals as a business courtesy to HCPs and their family members.
True
False - ✔✔False
✔✔Some of the risks REMS aim to mitigate include: (select all that apply)
Serious Infection
Liver damage
Severe birth defects
Severe allergic reaction - ✔✔Serious Infection
Liver damage
Severe birth defects
Severe allergic reaction
✔✔The ultimate objective of a medical brand strategy is advancing:
Clinical Practice
Medical science
,Patient Outcomes
All of these are true - ✔✔All of these are true
✔✔Labeling for the prescribing information takes place:
After an NDA is approved
Before an IND is filed
During post-market research
After the FDA determines that the drug is safe and effective - ✔✔After the FDA
determines that the drug is safe and effective
✔✔Payments to external authors are permissible as long as the following criteria are
met:
The author states his/her conflict of interest on the final manuscript.
The author has had a long standing relationship with the pharmaceutical company.
The author is writing a review article that is promotional in nature.
The author is close friends with the CEO of the pharmaceutical company. - ✔✔The
author is writing a review article that is promotional in nature.
✔✔The stage at which experiments are conducted on humans is during:
Discovery phase
Labeling process
Clinical trials
Pre-clinical trials - ✔✔Clinical trials
✔✔Equivalence studies are conducted when
The researcher wants to examine whether the treatment is similar to a control
Sampling from a target population is difficult
It is unethical to provide one group with the treatment
The researcher wants to test whether the effect of a new drug is not statistically
significant from the effect of a standard one - ✔✔The researcher wants to examine
whether the treatment is similar to a control
✔✔Identify the type of document or application submitted for marketing a vaccine:
BLA
IND
ANDA
NDA - ✔✔BLA
✔✔Procedures for performance standards development can be found under
,Sections 21 CFR 861
SOR/98-282
CFR 807 Subpart E
Section 510(k) - ✔✔Sections 21 CFR 861
✔✔True or False: Medical Information typically creates SRDs for products within the
company's pipeline in response to questions.
True
False - ✔✔True
✔✔Choose the correct answer about medical writing:
ICH guidelines are important in Regulatory Writing
Medical writing does not require good literature research skills
Medical writing is only valued within Medical Affairs - ✔✔ICH guidelines are important in
Regulatory Writing
✔✔True or False: Cohort studies and RCTs are both considered experimental studies
True
False - ✔✔False
✔✔Which of the following is NOT a tier of KOL identification?
Regional
Local
District
National - ✔✔District
✔✔According to the PhRMA Code, which of the following is an appropriate item for a
company to offer to a non-faculty HCP?
A $25 gift card for attending a company-sponsored CME program
A $40-worth anatomical model of the heart to be used in the office to educate patients
on heart failure
A stapler with the logo of company's new diabetes drug accompanied by patient
educational pamphlets
Tickets to a local baseball game - ✔✔A $40-worth anatomical model of the heart to be
used in the office to educate patients on heart failure
✔✔True or False: Medical Information reviews both promotional and non-promotional
materials in the scientific review committee.
True
, False - ✔✔True
✔✔Superiority trials are conducted when:
The researcher wants to test whether the effect of a new drug is better than the effect of
a standard one
The researcher wants to examine whether the treatment is similar to a control
It is unethical to provide one group with the treatment
Sampling from a target population is difficult - ✔✔The researcher wants to test whether
the effect of a new drug is better than the effect of a standard one
✔✔Time-dependent reactions include: (Select all that apply)
Delayed reactions that can occur after the drug has been discontinued
Reaction that only occurs after the first dose
Reactions that occur early in treatment
Due to administering two or more drugs at the same time
Reactions when a drug is administered too quickly
Reaction due to the patient's age - ✔✔Delayed reactions that can occur after the drug
has been discontinued
Reaction that only occurs after the first dose
Reactions that occur early in treatment
Reactions when a drug is administered too quickly
✔✔Identify the phase during which an IND is submitted:
Before clinical trials
After clinical trials
After the drug discovery process
Before pre-clinical trials - ✔✔Before clinical trials
✔✔The conclusion section should include (Select all that apply):
Significance of the study
Implications
Interpretation of p-values
Important Numerical findings
A summary of the study and its purpose - ✔✔Significance of the study
Implications
✔✔Discounting is a term that describes:
The discount of present costs based on future values
The discount a healthcare provider (HCP) gets when purchasing a certain device
The discount of future costs adjustments based on present values
