Which of the following is responsible for establishing guidelines for publication practices?
OIG
PhRMA
GPP3
FDA - GPP3
ICMJE guidelines are for:
Educational materials
Marketing materials
Manuscripts
Safety reports
Clinical trial protocols - Manuscripts
The results sections should include (Select all that apply):
Dropout rates
Limitations
A synopsis of the purpose of the study
Implications
The number of patients who completed the study
Numerical analysis - Dropout rates
Implications
The number of patients who completed the study
Numerical analysis
,The three essentials of an effective presentation are: (Select all that apply)
Audience
Improvisation
Think ahead
Prepare and know the data - Audience
Improvisation
Prepare and know the data
The primary role of the IRB is to
Ensure the protection and rights of research personnel.
Ensure the protection of subjects in a clinical study.
Ensure that policies regarding drug and medical device manufacturing are reinforced.
Ensure the protection of patients taking the marketed drug - Ensure the protection of subjects in a
clinical study.
When reaching the end of phase 3 of clinical trials, companies/sponsors should file what type of
application? (Select all that apply)
BLA
NDA
ANDA
IND - BLA
NDA
A study sought to examine the effects of beta-carotene and aspirin in preventing cardiovascular disease
and cancer. Approximately 10,000 male physicians were enrolled and randomized in order to evaluate
,the independent and combined effects of the two treatments. Which study design best describes this
trial?
Crossover
2 separate parallel randomized trials, one for beta-carotene and one for aspirin
Factorial
Group allocation - Factorial
How long should an experienced MSL generally expect to prepare for prior to a KOL meeting?
1 hour
Twice as long as the meeting allotment
1 day
Equivalent to the meeting allotment - Twice as long as the meeting allotment
To help your audience understand how your product is of relevance to them, you need to:
Provide a concise biography of yourself
Be able to read the room
Provide a clear purpose statement at the beginning of the presentation
Be able to make an impression in the first 7 minutes - Provide a clear purpose statement at the
beginning of the presentation
True or False: Medical Affairs has become more of an important role in the success of advisory boards.
True
False - True
Filing a 510(K) with the FDA demonstrates that a
, Device is class I
Device has a legally marketed predicate
Device is approved for market
Device is class II and safe - Device has a legally marketed predicate
Which of the following is not included in a scientific platform?
Strategic objectives
The important scientific information that will be communicated
Guidelines for selecting authors
Data from Phase IV - Guidelines for selecting authors
Which type of abstract is characterized by having results and conclusion:
Descriptive
Regulatory
Commercial
Informative - Informative
What are some of the core responsibilities of an MSL? (Select all that apply)
Communicating interest in ISS
Medical writing
Networking and identifying potential KOLs
Conducting market research
Developing slide kits for presentations
Understanding regulatory issues that may increase corporate risk
No choices are correct - Communicating interest in ISS
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