MI provides data-driven, targeted, and fair-balanced medical information for HCPs usually during what
phase? - Phase III clinical trials
What requires companies to report certain payments to the federal government? - The National
Physician Payment Transparency Program
Original publications, conference presentations, & dissertations are examples of what level of evidence?
- primary
Review articles, retrospective analyses, & meta-analyses are examples of what level of evidence? -
secondary
Textbooks, handbooks, & drug compendia are examples of what level of evidence? - tertiary
MI follows a 5-step process when responding to a Drug Information Question. Name them. - 1. knowing
who the audience is
2. understanding the primary question
3. developing appropriate research strategy
4. choosing best source
5. assessing the info & answering the question
What do you call the material prepared for HCPs & other stakeholders answering their questions about
products? - Standard Response Documents (SRDs)
True or False? In SRDs, no conclusions are presented to avoid MI bias. - True
True or False? SRDs may not include unapproved drug uses. - False
, True or False? Medical Information review both promotional & non-promotional materials in the
scientific review committee. - True
Information considered "off-label" should only be communicated by MSLs if they receive what? - ...
unsolicited requests by HCPs
Unsolicited communication of off-label or unapproved info by pharma manufacturers violates what? -
the Federal Food, Drug, & Cosmetic Act of 1938 (FD&C Act)
True or False? MSLs are responsible for identifying authors for publications. - True
Federal anti-kickback statute
a) allows MSLs to interact with KOLs
b) regulated the number of KOL each MSL may interact with
c) regulates investigator-sponsored studies
d) regulates publications by pharma companies - c) regulates investigator-sponsored studies
Why are ISS valuable to a pharma company? - may identify an area of unmet needs for a drug's use
Which MSL tier is responsible for training the sales team? - MSL associates
Aside of MSL directors & trainers, what are the levels of MSLs? - level I - MSL
level II - Senior MSL
level III - Principal (Distinguished) MSL
What are the 3 key steps in grant submission? - - pre-award
- submission/approval
- post-award
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