BCMAS EXAM (ACTUAL EXAM) WITH
QUESTIONS WITH VERY ELABORATED
ANSWERS CORRECTRY WELL ORGANIZED
LATEST 2024 – 2025 ALREADY GRADED A+
What is another name for a group allocation design? - ANSWERS-cluster
randomization
Khaled, a Medical Information Specialist, is following a 5-step process to respond
to a Medical Information question. What is the third step they should follow? -
ANSWERS-Develop an appropriate research strategy
What IVD market segment would Molecular Diagnostics belong to? - ANSWERS-
technique
T/F: Manufacturers are not required to report serious adverse events to the FDA.
- ANSWERS-False
,Not required by ADR reporting: - ANSWERS-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: - ANSWERS-advisors
in vitro diagnostic test - example - ANSWERS-microbiology culture
in vitro versus in vivo - ANSWERS-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: - ANSWERS-
timely data collection
Best practice and ethical standards for reporting research published in medical
journals - ANSWERS-ICMJE
,Most commonly used study design: - ANSWERS-parallel
Under what conditions can a pharma company provide financial support for
conferences and CME? - ANSWERS-The grants/contributions are separate from
other company funds
The company has had no control over the selection of content, faculty, or venue
T/F: Elements to Assure Safe Use (ETASU) are required medical interventions
taken by HCPs prior to using the drug. - ANSWERS-True
Combination product applicant(s) - ANSWERS-The company that holds the
application for the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS. - ANSWERS-False
Export challenge of a medical device company: - ANSWERS-Violation of
intellectual property rights
Purposes of IIS - ANSWERS-develop and support new indication
enhance pt benefits/health outcomes
, improve available product safety and
NOT a purpose = support pt community
Goals of pharmacogenomics - ANSWERS-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 - ANSWERS-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 - ANSWERS-DynaMed
Cochrane Library
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