BCMAS Exam Questions Bank July 2024 | Questions & Answers (100 %Score) Latest
Updated 2024/2025 Comprehensive Questions A+ Graded Answers | With Expert Solutions
One of the important functions of an advisory board is to: - Address knowledge gaps
Point-of-Care diagnostics are: - Simple medical tests that may produce immediate results
True or False: Publication planning is generally overseen by Medical Affairs. - True
A researcher decides to test whether completing a certain cardio workout regimen helps reduce
cholesterol levels in male cardiac patients. To reduce sampling error, the researcher needs to: - Ensure
that the participants have similar characteristics
True or False: IIS are similar to industry sponsored trials in that they must be carried out in accordance
with GCP. - True
A company filling a MAA is the function of - Regulatory
Criteria for ADR reports to be considered valid and reportable include all of the following, except: -
Confirmatory evidence of the ADR
When is a cost minimization analysis (CMA) used? - When all outcomes are expected to be equal
An SRD may include: - Unapproved use of the drug
A Pharmaceutical company is exploring options of extending the patent of their leading rheumatoid
arthritis drug. What in your opinion should be the best strategy to do so? - Ask the researcher and
development team to create a new delivery system for the drug
Once the UK withdraws from the EU, they will no longer be part of the centralized approval procedure
for the EMA. Which of the following will MAHs in the UK not need to transfer? - Pediatric Investigation
Plans
,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
True or False: MSLs can communicate off-label information about a company's product upon unsolicited
requests by an HCP. - True.
Subjects receive both types of treatments in a: - Crossover design
True or False: It is appropriate to provide HCPs promotional materials such as pens, mugs or notepads as
long as the drug and company name are clearly written on the items. - False.
When are the probabilities of outcomes determined during a pharmacoeconomic analysis? - After
identifying necessary resources to conduct analysis.
The five steps of EBM practice are: - Use the PICO method > conduct a literature review > evaluate
available evidence > examine applicability of evidence > reach a conclusive clinical judgment.
True or False: IIS can also be conducted on drugs/devices that are already available on market. - True.
Failing to reject the null hypothesis when it is false is known as: - Making a type 2 error.
You are presenting to a group of clinical scientists on the topic of dyslipidemia. All of the following are
aspects of your presentation to focus except: - Give your best "elevator pitch".
AI will have potential value when it comes to clinical trials by increasing enrolment and efficiency. - True.
Which of the following is a classification of an ADR? - - Bizarre effects
- Failure of therapy
- Genetic
- Delayed effects
, Reimbursement challenges that medtech companies may face include: - Companies can run into
situations where they are faced with irregular data requirements.
The following best describe cohort studies: - - Cohort study starts at level of exposure and evaluate the
likelihood of outcome due to exposure
- Cohort study is suitable to study rare exposures or multiple outcomes
What should always be contained in the response to a medical information question within the SRD? -
Approved product labelling.
Which of the following is NOT a tier of KOL identification? - District.
When is a cost effectiveness analysis (CEA) used? - When outcomes of each treatment are measured in
non-monetary units.
Which of the following is not included in a scientific platform? - Guidelines for selecting authors.
The difference between the communication plan and the medication guide is that the communication
plan: - Is directed to HCPs and not the patient.
There are specific MAA procedures for all of the following, except: - All of these have specific MAA
procedures (Biosimilars, Hybrid Medicines, Orphan Medicines).
True or False: Medical Information typically creates SRDs for products within the company's pipeline in
response to questions. - True.
True or False: Michael, a senior MSL at ACME Biotech can be asked to present health outcomes data for
his company's new product. - True.
Which of the following is NOT an example of Molecular Diagnostics? - Lipid panel testing.
Updated 2024/2025 Comprehensive Questions A+ Graded Answers | With Expert Solutions
One of the important functions of an advisory board is to: - Address knowledge gaps
Point-of-Care diagnostics are: - Simple medical tests that may produce immediate results
True or False: Publication planning is generally overseen by Medical Affairs. - True
A researcher decides to test whether completing a certain cardio workout regimen helps reduce
cholesterol levels in male cardiac patients. To reduce sampling error, the researcher needs to: - Ensure
that the participants have similar characteristics
True or False: IIS are similar to industry sponsored trials in that they must be carried out in accordance
with GCP. - True
A company filling a MAA is the function of - Regulatory
Criteria for ADR reports to be considered valid and reportable include all of the following, except: -
Confirmatory evidence of the ADR
When is a cost minimization analysis (CMA) used? - When all outcomes are expected to be equal
An SRD may include: - Unapproved use of the drug
A Pharmaceutical company is exploring options of extending the patent of their leading rheumatoid
arthritis drug. What in your opinion should be the best strategy to do so? - Ask the researcher and
development team to create a new delivery system for the drug
Once the UK withdraws from the EU, they will no longer be part of the centralized approval procedure
for the EMA. Which of the following will MAHs in the UK not need to transfer? - Pediatric Investigation
Plans
,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
True or False: MSLs can communicate off-label information about a company's product upon unsolicited
requests by an HCP. - True.
Subjects receive both types of treatments in a: - Crossover design
True or False: It is appropriate to provide HCPs promotional materials such as pens, mugs or notepads as
long as the drug and company name are clearly written on the items. - False.
When are the probabilities of outcomes determined during a pharmacoeconomic analysis? - After
identifying necessary resources to conduct analysis.
The five steps of EBM practice are: - Use the PICO method > conduct a literature review > evaluate
available evidence > examine applicability of evidence > reach a conclusive clinical judgment.
True or False: IIS can also be conducted on drugs/devices that are already available on market. - True.
Failing to reject the null hypothesis when it is false is known as: - Making a type 2 error.
You are presenting to a group of clinical scientists on the topic of dyslipidemia. All of the following are
aspects of your presentation to focus except: - Give your best "elevator pitch".
AI will have potential value when it comes to clinical trials by increasing enrolment and efficiency. - True.
Which of the following is a classification of an ADR? - - Bizarre effects
- Failure of therapy
- Genetic
- Delayed effects
, Reimbursement challenges that medtech companies may face include: - Companies can run into
situations where they are faced with irregular data requirements.
The following best describe cohort studies: - - Cohort study starts at level of exposure and evaluate the
likelihood of outcome due to exposure
- Cohort study is suitable to study rare exposures or multiple outcomes
What should always be contained in the response to a medical information question within the SRD? -
Approved product labelling.
Which of the following is NOT a tier of KOL identification? - District.
When is a cost effectiveness analysis (CEA) used? - When outcomes of each treatment are measured in
non-monetary units.
Which of the following is not included in a scientific platform? - Guidelines for selecting authors.
The difference between the communication plan and the medication guide is that the communication
plan: - Is directed to HCPs and not the patient.
There are specific MAA procedures for all of the following, except: - All of these have specific MAA
procedures (Biosimilars, Hybrid Medicines, Orphan Medicines).
True or False: Medical Information typically creates SRDs for products within the company's pipeline in
response to questions. - True.
True or False: Michael, a senior MSL at ACME Biotech can be asked to present health outcomes data for
his company's new product. - True.
Which of the following is NOT an example of Molecular Diagnostics? - Lipid panel testing.
