BCMAS Exam Questions With Correct
Answers
Most commonly used study design: - CORRECT ANSWER✔✔-parallel
| | | | | | |
Under what conditions can a pharma company provide financial support
| | | | | | | | |
for conferences and CME? - CORRECT ANSWER✔✔-The
| | | | | | |
grants/contributions are separate from other company funds
| | | | | | |
The company has had no control over the selection of content, faculty,
| | | | | | | | | | | |
or venue
|
Not required by ADR reporting: - CORRECT ANSWER✔✔-careful
| | | | | | | |
selection of clinical trial participants
| | | |
Required:
-recognition of events | |
-safety signals are identified against a background of events
| | | | | | | |
-accurate reporting |
,Individual board members are known as: - CORRECT ANSWER✔✔-
| | | | | | | |
advisors
in vitro diagnostic test - example - CORRECT ANSWER✔✔-microbiology
| | | | | | | | |
culture
in vitro versus in vivo - CORRECT ANSWER✔✔-in vitro describes
| | | | | | | | | |
something "in glass" such as a test tube or petri dish
| | | | | | | | | |
in vivo is "within a living organism"
| | | | | |
Fundamental requirement for ongoing risk evaluations of REMS: -
| | | | | | | | |
CORRECT ANSWER✔✔-timely data collection
| | |
Best practice and ethical standards for reporting research published in
| | | | | | | | | |
medical journals - CORRECT ANSWER✔✔-ICMJE
| | | |
T/F: Elements to Assure Safe Use (ETASU) are required medical
| | | | | | | | | |
interventions taken by HCPs prior to using the drug. - CORRECT
| | | | | | | | | | |
ANSWER✔✔-True
Combination product applicant(s) - CORRECT ANSWER✔✔-The
| | | | | |
company that holds the application for the combination product as a
| | | | | | | | | | |
whole
,T/F: Severe birth defects is not an FDA mandated REMS. - CORRECT
| | | | | | | | | | | |
ANSWER✔✔-False
Export challenge of a medical device company: - CORRECT ANSWER✔✔-
| | | | | | | | |
Violation of intellectual property rights
| | | |
Purposes of IIS - CORRECT ANSWER✔✔-develop and support new
| | | | | | | | |
indication
enhance pt benefits/health outcomes
| | |
improve available product safety and
| | | | |
NOT a purpose = support pt community
| | | | | |
Goals of pharmacogenomics - CORRECT ANSWER✔✔-Individualize
| | | | | |
therapies based on genetic differences | | | |
Predict individual responses to a drug to decrease adverse drug
| | | | | | | | | |
reactions
Improve the overall efficacy and safety of drugs
| | | | | | |
NOT a goal = decrease medication adherence
| | | | | |
, FDA clearance for medical devices - CORRECT ANSWER✔✔-May be
| | | | | | | | |
given for devices with substantial equivalence to a known predicate
| | | | | | | | | |
device
Allows the device to be marketed and sold once a Pre-Market
| | | | | | | | | | |
Notification has been submitted | | |
May be issued if the device existed in the market prior to 1976
| | | | | | | | | | | |
EBM databases - CORRECT ANSWER✔✔-DynaMed
| | | |
Cochrane Library |
T/F: Presentation skills are not essential for maintaining a position with
| | | | | | | | | | |
MA. - CORRECT ANSWER✔✔-False
| | |
What would cause the FDA to require post-marketing studies or clinical
| | | | | | | | | | |
trials at the time of approval or afterwards for a new product? -
| | | | | | | | | | | | |
CORRECT ANSWER✔✔-If the FDA becomes aware of new safety
| | | | | | | | |
information from SADR reporting. | | |
When first working on a publication, what should authors do to identify
| | | | | | | | | | | |
their rights, roles, and responsibilities? - CORRECT ANSWER✔✔-
| | | | | | |
Document the agreement | |
Answers
Most commonly used study design: - CORRECT ANSWER✔✔-parallel
| | | | | | |
Under what conditions can a pharma company provide financial support
| | | | | | | | |
for conferences and CME? - CORRECT ANSWER✔✔-The
| | | | | | |
grants/contributions are separate from other company funds
| | | | | | |
The company has had no control over the selection of content, faculty,
| | | | | | | | | | | |
or venue
|
Not required by ADR reporting: - CORRECT ANSWER✔✔-careful
| | | | | | | |
selection of clinical trial participants
| | | |
Required:
-recognition of events | |
-safety signals are identified against a background of events
| | | | | | | |
-accurate reporting |
,Individual board members are known as: - CORRECT ANSWER✔✔-
| | | | | | | |
advisors
in vitro diagnostic test - example - CORRECT ANSWER✔✔-microbiology
| | | | | | | | |
culture
in vitro versus in vivo - CORRECT ANSWER✔✔-in vitro describes
| | | | | | | | | |
something "in glass" such as a test tube or petri dish
| | | | | | | | | |
in vivo is "within a living organism"
| | | | | |
Fundamental requirement for ongoing risk evaluations of REMS: -
| | | | | | | | |
CORRECT ANSWER✔✔-timely data collection
| | |
Best practice and ethical standards for reporting research published in
| | | | | | | | | |
medical journals - CORRECT ANSWER✔✔-ICMJE
| | | |
T/F: Elements to Assure Safe Use (ETASU) are required medical
| | | | | | | | | |
interventions taken by HCPs prior to using the drug. - CORRECT
| | | | | | | | | | |
ANSWER✔✔-True
Combination product applicant(s) - CORRECT ANSWER✔✔-The
| | | | | |
company that holds the application for the combination product as a
| | | | | | | | | | |
whole
,T/F: Severe birth defects is not an FDA mandated REMS. - CORRECT
| | | | | | | | | | | |
ANSWER✔✔-False
Export challenge of a medical device company: - CORRECT ANSWER✔✔-
| | | | | | | | |
Violation of intellectual property rights
| | | |
Purposes of IIS - CORRECT ANSWER✔✔-develop and support new
| | | | | | | | |
indication
enhance pt benefits/health outcomes
| | |
improve available product safety and
| | | | |
NOT a purpose = support pt community
| | | | | |
Goals of pharmacogenomics - CORRECT ANSWER✔✔-Individualize
| | | | | |
therapies based on genetic differences | | | |
Predict individual responses to a drug to decrease adverse drug
| | | | | | | | | |
reactions
Improve the overall efficacy and safety of drugs
| | | | | | |
NOT a goal = decrease medication adherence
| | | | | |
, FDA clearance for medical devices - CORRECT ANSWER✔✔-May be
| | | | | | | | |
given for devices with substantial equivalence to a known predicate
| | | | | | | | | |
device
Allows the device to be marketed and sold once a Pre-Market
| | | | | | | | | | |
Notification has been submitted | | |
May be issued if the device existed in the market prior to 1976
| | | | | | | | | | | |
EBM databases - CORRECT ANSWER✔✔-DynaMed
| | | |
Cochrane Library |
T/F: Presentation skills are not essential for maintaining a position with
| | | | | | | | | | |
MA. - CORRECT ANSWER✔✔-False
| | |
What would cause the FDA to require post-marketing studies or clinical
| | | | | | | | | | |
trials at the time of approval or afterwards for a new product? -
| | | | | | | | | | | | |
CORRECT ANSWER✔✔-If the FDA becomes aware of new safety
| | | | | | | | |
information from SADR reporting. | | |
When first working on a publication, what should authors do to identify
| | | | | | | | | | | |
their rights, roles, and responsibilities? - CORRECT ANSWER✔✔-
| | | | | | |
Document the agreement | |
