BCMAS EXAM QUESTIONS WITH
CORRECT ANSWERS
Which of the following is responsible for establishing guidelines for
| | | | | | | | | |
publication practices? |
OIG
PhRMA
GPP3
FDA - CORRECT ANSWER✔✔-GPP3
| | |
ICMJE guidelines are for:
| | |
Educational materials |
Marketing materials |
Manuscripts
Safety reports|
Clinical trial protocols - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT
| | | | | | | | | | |
ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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
| | | | | | | | | |
CORRECT ANSWERS
Which of the following is responsible for establishing guidelines for
| | | | | | | | | |
publication practices? |
OIG
PhRMA
GPP3
FDA - CORRECT ANSWER✔✔-GPP3
| | |
ICMJE guidelines are for:
| | |
Educational materials |
Marketing materials |
Manuscripts
Safety reports|
Clinical trial protocols - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT
| | | | | | | | | | |
ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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 - CORRECT ANSWER✔✔-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
| | | | | | | | | |
