BCMAS STUDY GUIDE | BOARD CERTIFIED MEDICAL AFFAIRS SPECIALIST
CERTIFICATION EXAM REVIEW QUESTIONS AND ANSWERS 2026/2027
Which of the following is responsible for establishing guidelines for publication practices?
OIG
PhRMA
GPP3
FDA - correct answer ✔✔GPP3
ICMJE guidelines are for:
Educational materials
Marketing materials
Manuscripts
Safety reports
Clinical trial protocols - correct answer ✔✔Manuscripts
The results sections should include (Select all that apply):
Dropout rates
Limitations
A synopsis of the purpose of the study
Implications
The number of patients who completed the study
Numerical analysis - correct answer ✔✔Dropout rates
Implications
The number of patients who completed the study
Numerical analysis
The three essentials of an effective presentation are: (Select all that apply)
Audience
Improvisation
Think ahead
Prepare and know the data - correct answer ✔✔Audience
Improvisation
Prepare and know the data
The primary role of the IRB is to
Ensure the protection and rights of research personnel.
Ensure the protection of subjects in a clinical study.
Ensure that policies regarding drug and medical device manufacturing are reinforced.
Ensure the protection of patients taking the marketed drug - correct answer ✔✔Ensure the protection of
subjects in a clinical study.
,When reaching the end of phase 3 of clinical trials, companies/sponsors should file what type of
application? (Select all that apply)
BLA
NDA
ANDA
IND - correct answer ✔✔BLA
NDA
A study sought to examine the effects of beta-carotene and aspirin in preventing cardiovascular disease
and cancer. Approximately 10,000 male physicians were enrolled and randomized in order to evaluate
the independent and combined effects of the two treatments. Which study design best describes this
trial?
Crossover
2 separate parallel randomized trials, one for beta-carotene and one for aspirin
Factorial
Group allocation - correct answer ✔✔Factorial
How long should an experienced MSL generally expect to prepare for prior to a KOL meeting?
1 hour
Twice as long as the meeting allotment
1 day
Equivalent to the meeting allotment - correct answer ✔✔Twice as long as the meeting allotment
To help your audience understand how your product is of relevance to them, you need to:
Provide a concise biography of yourself
Be able to read the room
Provide a clear purpose statement at the beginning of the presentation
Be able to make an impression in the first 7 minutes - correct answer ✔✔Provide a clear purpose
statement at the beginning of the presentation
True or False: Medical Affairs has become more of an important role in the success of advisory boards.
True
False - correct answer ✔✔True
Filing a 510(K) with the FDA demonstrates that a
Device is class I
Device has a legally marketed predicate
Device is approved for market
Device is class II and safe - correct answer ✔✔Device has a legally marketed predicate
Which of the following is not included in a scientific platform?
,Strategic objectives
The important scientific information that will be communicated
Guidelines for selecting authors
Data from Phase IV - correct answer ✔✔Guidelines for selecting authors
Which type of abstract is characterized by having results and conclusion:
Descriptive
Regulatory
Commercial
Informative - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔False
Some of the risks REMS aim to mitigate include: (select all that apply)
Serious Infection
Liver damage
Severe birth defects
Severe allergic reaction - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔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. - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔BLA
Procedures for performance standards development can be found under
Sections 21 CFR 861
SOR/98-282
CFR 807 Subpart E
Section 510(k) - correct answer ✔✔Sections 21 CFR 861
CERTIFICATION EXAM REVIEW QUESTIONS AND ANSWERS 2026/2027
Which of the following is responsible for establishing guidelines for publication practices?
OIG
PhRMA
GPP3
FDA - correct answer ✔✔GPP3
ICMJE guidelines are for:
Educational materials
Marketing materials
Manuscripts
Safety reports
Clinical trial protocols - correct answer ✔✔Manuscripts
The results sections should include (Select all that apply):
Dropout rates
Limitations
A synopsis of the purpose of the study
Implications
The number of patients who completed the study
Numerical analysis - correct answer ✔✔Dropout rates
Implications
The number of patients who completed the study
Numerical analysis
The three essentials of an effective presentation are: (Select all that apply)
Audience
Improvisation
Think ahead
Prepare and know the data - correct answer ✔✔Audience
Improvisation
Prepare and know the data
The primary role of the IRB is to
Ensure the protection and rights of research personnel.
Ensure the protection of subjects in a clinical study.
Ensure that policies regarding drug and medical device manufacturing are reinforced.
Ensure the protection of patients taking the marketed drug - correct answer ✔✔Ensure the protection of
subjects in a clinical study.
,When reaching the end of phase 3 of clinical trials, companies/sponsors should file what type of
application? (Select all that apply)
BLA
NDA
ANDA
IND - correct answer ✔✔BLA
NDA
A study sought to examine the effects of beta-carotene and aspirin in preventing cardiovascular disease
and cancer. Approximately 10,000 male physicians were enrolled and randomized in order to evaluate
the independent and combined effects of the two treatments. Which study design best describes this
trial?
Crossover
2 separate parallel randomized trials, one for beta-carotene and one for aspirin
Factorial
Group allocation - correct answer ✔✔Factorial
How long should an experienced MSL generally expect to prepare for prior to a KOL meeting?
1 hour
Twice as long as the meeting allotment
1 day
Equivalent to the meeting allotment - correct answer ✔✔Twice as long as the meeting allotment
To help your audience understand how your product is of relevance to them, you need to:
Provide a concise biography of yourself
Be able to read the room
Provide a clear purpose statement at the beginning of the presentation
Be able to make an impression in the first 7 minutes - correct answer ✔✔Provide a clear purpose
statement at the beginning of the presentation
True or False: Medical Affairs has become more of an important role in the success of advisory boards.
True
False - correct answer ✔✔True
Filing a 510(K) with the FDA demonstrates that a
Device is class I
Device has a legally marketed predicate
Device is approved for market
Device is class II and safe - correct answer ✔✔Device has a legally marketed predicate
Which of the following is not included in a scientific platform?
,Strategic objectives
The important scientific information that will be communicated
Guidelines for selecting authors
Data from Phase IV - correct answer ✔✔Guidelines for selecting authors
Which type of abstract is characterized by having results and conclusion:
Descriptive
Regulatory
Commercial
Informative - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔False
Some of the risks REMS aim to mitigate include: (select all that apply)
Serious Infection
Liver damage
Severe birth defects
Severe allergic reaction - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔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. - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔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 - correct answer ✔✔BLA
Procedures for performance standards development can be found under
Sections 21 CFR 861
SOR/98-282
CFR 807 Subpart E
Section 510(k) - correct answer ✔✔Sections 21 CFR 861
