AND ANSWERS SURE A+
✔✔T/F: Under the second-tier compliance regulations, in 21 CFR Part 50 (Protection of
Human Subjects), subpart B addresses detailed requirements for informed consent. -
✔✔True
✔✔What is outcomes research? - ✔✔An attempt to identify, measure, and evaluate the
results of health care services
✔✔Which advisory board is composed of up to 15 members with different backgrounds
for a large-sized company? - ✔✔multidisciplinary team
✔✔What are the four key drivers of growth in the pharmaceutical industry? - ✔✔aging
population
changing lifestyle
rise in chronic disease
globalization
✔✔Under what conditions may a company use prescriber data?
A) Use data with all information related to patient identity omitted
B) Use data to track adverse events of marketed prescription drugs
C) Use data to focus marketing activities towards HCPs who would most likely benefit
from the drug information.
D) Only use data if a physician has NOT made a request that their data not be made
available to sales representatives - ✔✔A, B, D
✔✔T/F: Post-Marketing Commitments (PMCs) include study designs not mandated by
the FDA. - ✔✔True
✔✔Your company now has sufficient evidence on safety and efficacy for a new COVID-
19 vaccine, and you are now ready to apply to launch your product on the market.
Which application do you need to file now? - ✔✔BLA (Biologics License Application)
✔✔Which of the following A/B Classification categories is an augmented pharmacologic
effect that is dose dependent and predictable? - ✔✔Type A
✔✔What science is involved in the detection, assessment, and prevention of adverse
effects in medicine? - ✔✔Pharmacovigilance
✔✔What is the first step to initiate the grant process? - ✔✔Identify the potential funding
source
, ✔✔What ratio of content to interactivity should you strive to maintain in a presentation?
- ✔✔10/30
✔✔In clinical research which term best represents the probability of developing the
outcome in the exposed group/the unexposed group? - ✔✔Odds ratio
✔✔How have the Good Publication Practices (GPP) Guidelines for Sponsored Medical
Research ensured industry standards? - ✔✔Ensure that medical and scientific
publications achieve the highest possible standards in publishing
✔✔T/F: Bias is any systematic error or influence that causes an estimated treatment
effect to deviate from the true effect. - ✔✔True
✔✔What does the "I" stand for in the PICO approach to practicing evidence-based
medicine? - ✔✔Intervention
✔✔PICO - ✔✔Patient/Population
Intervention
Comparison
Outcomes
✔✔In preparing a proposal for a grant, it is important to assemble all the information,
including:
A) Purposes of the grant
B) Detailed plans
C) Work schedule
D) Budget information - ✔✔A, B, D
✔✔Which of the following is a recommendation from the GPP guidelines? - ✔✔All
authors and contributors should disclose any relationships or potential competing
interests relating to the research
✔✔T/F: A medical science liaison is tasked with creating a slide deck for a medical
conference for physicians. The target audience is physicians. - ✔✔True
✔✔T/FL Overgeneralization and relying on citations without qualifications are
challenges around impact and influence measurements using scholarly big data. -
✔✔True
✔✔Your company is developing a drug, and is getting ready to initiate clinical trials.
Which type of application do you need to file with the FDA to obtain approval to initiate
clinical trials? - ✔✔IND (Investigational New Drug application)