BCMAS EXAM QUESTIONS AND ANSWERS
Most commonly used study design: - Answer -parallel
Under what conditions can a pharma company provide financial support for conferences
and CME? - Answer -The grants/contributions are separate from other company funds
The company has had no control over the selection of content, faculty, or venue
Not required by ADR reporting: - Answer -careful selection of clinical trial participants
Required:
-recognition of events
-safety signals are identified against a background of events
-accurate reporting
Individual board members are known as: - Answer -advisors
in vitro diagnostic test - example - Answer -microbiology culture
in vitro versus in vivo - Answer -in vitro describes something "in glass" such as a test
tube or petri dish
in vivo is "within a living organism"
Fundamental requirement for ongoing risk evaluations of REMS: - Answer -timely data
collection
Best practice and ethical standards for reporting research published in medical journals
- Answer -ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required medical interventions taken by
HCPs prior to using the drug. - Answer -True
Combination product applicant(s) - Answer -The company that holds the application for
the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS. - Answer -False
Export challenge of a medical device company: - Answer -Violation of intellectual
property rights
Purposes of IIS - Answer -develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
,NOT a purpose = support pt community
Goals of pharmacogenomics - Answer -Individualize therapies based on genetic
differences
Predict individual responses to a drug to decrease adverse drug reactions
Improve the overall efficacy and safety of drugs
NOT a goal = decrease medication adherence
FDA clearance for medical devices - Answer -May be given for devices with substantial
equivalence to a known predicate device
Allows the device to be marketed and sold once a Pre-Market Notification has been
submitted
May be issued if the device existed in the market prior to 1976
EBM databases - Answer -DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with MA. - Answer -
False
The risk associated with this type of drug may not be well understood. - Answer -New
drug substance
Amber is an MSL and receives a question from a physician about a medication
indication that is not FDA approved. Which of the following is true? - Answer -This is an
unsolicited request.
This information is off-label.
A Pharma company is looking to begin the development of a new drug. Why would the
company consult an advisory board? - Answer -To provide their opinion on the
research and development of the drug
T/F: Under the second-tier regulations, in 21 CFR Part 56 (Institutional Review Board
(IRB)) subpart B, there needs to be a minimum of 2 members in the IRB. - Answer -
False
Which are considered key items the FDA will contemplate when deciding on whether
REMS is needed? - Answer -Seriousness of the disease
Seriousness of side effects
Benefit of the drug
, In research which of the terms below describes a distortion caused by other variables to
both exposure and outcome? - Answer -confounding
T/F: Medical writers should avoid addressing the public's questions to prevent the
spread of health misinformation. - Answer -False
What are some of the ways that companies can benefit from non-mandated Post-
Marketing studies? - Answer -Detect any cost-benefits associated with the drugs
Compare a drug with other currently available medications in the same class
Detect other uses of the drugs
Approximately how many slides should a 15 minute presentation include? - Answer -7-
8
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? - Answer -Yes, it would be unethical and
potentially a conflict of interest if she does not disclose the relationship.
What would cause the FDA to require post-marketing studies or clinical trials at the time
of approval or afterwards for a new product? - Answer -If the FDA becomes aware of
new safety information from SADR reporting.
When first working on a publication, what should authors do to identify their rights, roles,
and responsibilities? - Answer -Document the agreement
The process of internal cooperation, coordination, and common standards across the
global pharmaceutical industry is referred to as: - Answer -Harmonization
5-step process to respond to a medical information question - Answer -1) Determine
who the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
4) Choose the best source
5) Assess the information source and answer the question
T/f: SRDs are prepared only for HCPs in response to questions about product(s). -
Answer -False
Who is required to submit a periodic safety update report? - Answer -Marketing
authorization holders (MAHs) according to the data points outlined in the EURD list.
Most commonly used study design: - Answer -parallel
Under what conditions can a pharma company provide financial support for conferences
and CME? - Answer -The grants/contributions are separate from other company funds
The company has had no control over the selection of content, faculty, or venue
Not required by ADR reporting: - Answer -careful selection of clinical trial participants
Required:
-recognition of events
-safety signals are identified against a background of events
-accurate reporting
Individual board members are known as: - Answer -advisors
in vitro diagnostic test - example - Answer -microbiology culture
in vitro versus in vivo - Answer -in vitro describes something "in glass" such as a test
tube or petri dish
in vivo is "within a living organism"
Fundamental requirement for ongoing risk evaluations of REMS: - Answer -timely data
collection
Best practice and ethical standards for reporting research published in medical journals
- Answer -ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required medical interventions taken by
HCPs prior to using the drug. - Answer -True
Combination product applicant(s) - Answer -The company that holds the application for
the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS. - Answer -False
Export challenge of a medical device company: - Answer -Violation of intellectual
property rights
Purposes of IIS - Answer -develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
,NOT a purpose = support pt community
Goals of pharmacogenomics - Answer -Individualize therapies based on genetic
differences
Predict individual responses to a drug to decrease adverse drug reactions
Improve the overall efficacy and safety of drugs
NOT a goal = decrease medication adherence
FDA clearance for medical devices - Answer -May be given for devices with substantial
equivalence to a known predicate device
Allows the device to be marketed and sold once a Pre-Market Notification has been
submitted
May be issued if the device existed in the market prior to 1976
EBM databases - Answer -DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with MA. - Answer -
False
The risk associated with this type of drug may not be well understood. - Answer -New
drug substance
Amber is an MSL and receives a question from a physician about a medication
indication that is not FDA approved. Which of the following is true? - Answer -This is an
unsolicited request.
This information is off-label.
A Pharma company is looking to begin the development of a new drug. Why would the
company consult an advisory board? - Answer -To provide their opinion on the
research and development of the drug
T/F: Under the second-tier regulations, in 21 CFR Part 56 (Institutional Review Board
(IRB)) subpart B, there needs to be a minimum of 2 members in the IRB. - Answer -
False
Which are considered key items the FDA will contemplate when deciding on whether
REMS is needed? - Answer -Seriousness of the disease
Seriousness of side effects
Benefit of the drug
, In research which of the terms below describes a distortion caused by other variables to
both exposure and outcome? - Answer -confounding
T/F: Medical writers should avoid addressing the public's questions to prevent the
spread of health misinformation. - Answer -False
What are some of the ways that companies can benefit from non-mandated Post-
Marketing studies? - Answer -Detect any cost-benefits associated with the drugs
Compare a drug with other currently available medications in the same class
Detect other uses of the drugs
Approximately how many slides should a 15 minute presentation include? - Answer -7-
8
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? - Answer -Yes, it would be unethical and
potentially a conflict of interest if she does not disclose the relationship.
What would cause the FDA to require post-marketing studies or clinical trials at the time
of approval or afterwards for a new product? - Answer -If the FDA becomes aware of
new safety information from SADR reporting.
When first working on a publication, what should authors do to identify their rights, roles,
and responsibilities? - Answer -Document the agreement
The process of internal cooperation, coordination, and common standards across the
global pharmaceutical industry is referred to as: - Answer -Harmonization
5-step process to respond to a medical information question - Answer -1) Determine
who the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
4) Choose the best source
5) Assess the information source and answer the question
T/f: SRDs are prepared only for HCPs in response to questions about product(s). -
Answer -False
Who is required to submit a periodic safety update report? - Answer -Marketing
authorization holders (MAHs) according to the data points outlined in the EURD list.
