Exam (elaborations)
BCMAS 1 QUESTIONS AND ANSWERS
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BCMAS 1 QUESTIONS AND ANSWERS
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Name: Score:24 Multiple choice questions
Term 1 of 24
You are conducting a study that does not require a mean and variance. What type of
distribution does that indicate you have?
Case-control
Standard Deviation
T-Distribution
Chairperson/moderator
Term 2 of 24
What is outcomes research?
A method to analyze the financial costs of health care services
A study focused solely on patient satisfaction surveys
An attempt to identify, measure, and evaluate the results of health care services
A process to develop new health care technologies
Term 3 of 24
True/False An Abbreviated New Drug Application (ANDA) is required for generic drug
approval.
True
False
,Term 4 of 24
Ashley is an MSL involved in reviewing drug promotional materials for a newly approved
medication for hypertension. Which of the following would be a goal for Ashley at her
medical-legal-regulatory review meeting tomorrow?
Focus on the financial benefits of the medication for the company
Promote the medication through aggressive marketing strategies
-A/B Alphabetic classification
-The Dose, Time, and Susceptibility (DOTS) classification
Provide physicians and patients with accurate, ethical, and unbiased drug information
Term 5 of 24
What role of Medical Affairs is responsible for documenting and reporting adverse events,
side effects, and safety issues?
Research
Pharmacovigilance
Safety Signal
Suspected Adverse Drug Reaction
Term 6 of 24
Which 2 systems are used to classify suspected adverse drug reactions? Select all that apply.
-Achievable
-Measurable
-Specific
-A/B Alphabetic classification
-The Dose, Time, and Susceptibility (DOTS) classification
-speaking during a transition
-hovering over the projector
-talking too quickly
Provide physicians and patients with accurate, ethical, and unbiased drug information
, Term 7 of 24
Which member of the board is tasked with guiding members to reach closure or consensus on
proposed issues?
Clinical Researcher
Chairperson/moderator
Nurse Practitioner
T-distribution
Term 8 of 24
Under the first-tier compliance regulations, which statement best describes 21 CFR Part 820
(subparts A-M)?
Guidelines For ethical marketing practices in pharmaceuticals
Standards For the training of healthcare professionals
GMP Quality system regulations for medical devices
Regulations Concerning the labeling of over-the-counter drugs
Term 9 of 24
TRUE/FALSE The primary function of an advisory board is to offer trusted advice on various
issues for the company.
True
False
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