Exam (elaborations)
BCMAS TERMS QUESTIONS AND ANSWERS
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BCMAS TERMS QUESTIONS AND ANSWERS
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Name: Score:150 Multiple choice questions
Definition 1 of 150
Conference poster, published trial
primary literature
Adjuvant Therapy
chronic diseases
FDA review post NDA
Definition 2 of 150
A type of result analyses of clinical trial that compares outcomes between study groups and
include only subjects who have completed the treatment protocol (no major violation of
protocol and receive at least 90% of the doses).
Per-protocol
Kick-off call
Superiority
Cohort study
Definition 3 of 150
a small study carried out to test the feasibility of a larger one. Pilot study is usually phase II
trials.
Adulteration
Pilot study
PMA for medical devices
tertiary literature
,Definition 4 of 150
Risk evaluation and mitigation strategy - a program designed by FDA to ensure the benefits of
the products outweigh their risks over time.
REMS
IIS
Bias
GPP3
Definition 5 of 150
The publications plan consists of re-analyzing the phase I, II, and III data, in addition to any
available data on phases IIIb and IV. The publications plan also includes the health economics
outcomes research (HEOR) data.
Who in the pharma company is involved in the publication approval process
Publication plan
Orphan drug
Communication plan
Definition 6 of 150
equivalence to predicate device
Bias
DHF
OPDP
510K
,Definition 7 of 150
The type of clinical study where participants are randomly assigned to two or more groups.
The experiment group(s) receives an intervention and the other (comparison or control group)
receives an alternative treatment or placebo.
Meta-analysis
Systematic review
Randomized controlled trial
Post-marketing surveillance
Definition 8 of 150
10 min of information for a 30 min presentation
Indirect cost
Superiority
10/30 rule
Fast track
Definition 9 of 150
The type of clinical study that uses statistical technique that summarizes the results of several
studies (usually RCTs) in a single weight estimate, in which more weight is given to results of
studies with more events and sometimes to studies of higher quality. Meta-analysis is a
quantitative summary of evidence to provide greater power than single studies.
Meta-analysis
ETASU
Randomized controlled trial
Pre-amendment devices
, Definition 10 of 150
Only required when the REMS include an ETASU section.
chronic diseases
Drug development phases
Informative Abstract
Medication Guide of REMS
Definition 11 of 150
PCR
DNA sequencing and NGS(Next gen sequencing)
Microarray
Considered state-of-the-art
Examples (CF carrier testing, MRSA/HPV screening, TB screening, BRAF, HIV viral load)
Molecular diagnostics examples
In vitro Diagnostics (IVD)
Phase II Clinical Trials
Essential presentation skills
Definition 12 of 150
2.3% on each device sold
Excise tax on devices
Observational study
Cross-sectional study
Is REMS dispensed with the drug
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