Exam (elaborations)
BCMAS TEST 3 QUESTIONS AND ANSWERS
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BCMAS TEST 3 QUESTIONS AND ANSWERS
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Name: Score:212 Multiple choice questions
Term 1 of 212
The abbreviation DHF stands for:
The design risk analysis file completed in Phase II
The design history file completed in Phase IV
The design risk analysis file completed in Phase III
The drug hazard file completed in Phase I
Term 2 of 212
Which of the following is a self-assessment that measures multiple aspects of a patient's
perceived well-being?
Health Status Assessment
Cost-benefit Assessment
Quantity of Life Assessment
Patient Preference Assessment
Term 3 of 212
Which of the following is considered "state-of-art" technology in in-vitro diagnostics arena?
DNA sequencing
Point-of-care
Immunoassays
Molecular Diagnostics
,Term 4 of 212
Which of the following best describes a publications workflow:
Selecting lead author → Identifying gaps in data → Kick-off call → Identifying
communication plan → Develop draft
Identifying communication plan → Identifying gaps in data → Selecting lead author →
Kick-off call → Develop draft
Kick-off call → Selecting lead author → Identifying communication plan → Identifying
gaps in data → Develop draft
Identifying gaps in data → Identifying communication plan →Selecting lead author →
Kick-off call → Develop draft
Term 5 of 212
Which of the following is NOT a tier of KOL identification?
Regional
Local
District
National
Term 6 of 212
True or False: It is recommended to use personal preference during advisory board selection.
For example, Dr. X has had a good relationship with company Y and therefore, tries to promote
their products as much as possible.
True
False
,Term 7 of 212
Which of the following are correct regarding initiating a REMS program?
REMS are initiated by independent investigators conducting ISS
REMS are initiated by the Company
REMS are initiated by FDA
REMS are initiated by Healthcare Professionals in conjunction with the Company
Term 8 of 212
True or false: A pharmaceutical company may fund a research grant for an investigator-
sponsored study provided the research aims to support evidence of drug efficacy.
True
False
Term 9 of 212
Which of the following warrant further investigation by the FDA:
A documented drug-drug interaction
Reports of a labeled adverse event
An increase in the frequency of a documented adverse drug event
Marketing of a drug that shows superiority
Term 10 of 212
ETASU is/are:
Medical intervention(s) that need to be undergone before drug use
A required medical guide given to the patient
A communication plan directed to HCPs
The patient package insert to be explained thoroughly to the patient before use
, Term 11 of 212
True or False. Sarah is an HEOR director at a mid-size biotech company and is trying to
determine what the most common discount rates are in the literature. She conducted a
literature review and uncovered that the most common discounted rates currently seen in the
literature are 3% to 5%.
True
False
Term 12 of 212
Which of the following describes a reactive interaction?
An MSL responding to an HCP asking for more information regarding possible
alternative indications
An MSL explaining to an HCP the PI of a drug
An MSL providing voluntary additional information about other possible indications of a
drug
An HCP asking for free samples
Term 13 of 212
True or False: Safety signals may be assessed through patient reports of severe adverse
events.
True
False
Term 14 of 212
True or False: Pharmacokinetics/pharmacodynamics profile of a drug is assessed during phase
1 of clinical trial.
True
False
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