BCMAS Exam Questions & Answers
Question : Which of the following is responsible for
establishing guidelines for publication practices?
OIG PhRMA GPP3 FDA
CORRECT ANSWER : GPP3
Question : ICMJE guidelines are for:
Educational materials Marketing materials Manuscripts Safety reports Clinical trial protocols
CORRECT ANSWER : Manuscripts
Question : 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
The number of patients who completed the study Numerical analysis
Question : The three essentials of an effective presentation
are: (Select all that apply)
Audience Improvisation Think ahead
Prepare and know the data
CORRECT ANSWER : Audience
Think ahead Prepare and know the data
Question : 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.
Question : 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
Question : 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
- separate parallel randomized trials, one for beta-carotene
and one for aspirin Factorial Group allocation