Exam (elaborations)
BCMAS 14-17 MI, MSLS, GRANTS, & BOARDS QUESTIONS AND ANSWERS
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BCMAS 14-17 MI, MSLS, GRANTS, & BOARDS QUESTIONS AND ANSWERS
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Name: Score:41 Multiple choice questions
Term 1 of 41
A successful advisory board is dependent upon
ensuring that all members have the same background
all members getting along
meetings set wit clear agendas
ensuring that the board has a single function
Term 2 of 41
Three reasons IIS may be sought would be to...
- pre-award
- submission/approval
- post-award
- improve safety & efficacy
- develop or support a new indication
- enhance patient benefits
- professional societies
- government agencies
- pharma companies
- biotech companies
- medical device companies
level I - MSL
level II - Senior MSL
level III - Principal (Distinguished) MSL
,Term 3 of 41
Investigators are help accountable to design a sound & ethical protocol & must abide by what
federal regulations?
The National Physician Payment Transparency Program
the Federal Food, Drug, & Cosmetic Act of 1938 (FD&C Act)
- 21 CFR 312.50
- SOPs (standard operating procedures)
- designing
- conducting
- recruiting
- reporting
Term 4 of 41
Types of advisory boards include:
- improve safety & efficacy
- develop or support a new indication
- enhance patient benefits
- single function
- multidisciplinary team
may identify an area of unmet needs for a drug's use
- pre-award
- submission/approval
- post-award
,Term 5 of 41
During ISS, companies that own the products can still provide support by offering what?
- designing
- conducting
- recruiting
- reporting
Promotional Medical Education Agencies
equipment, products, or financial support
... unsolicited requests by HCPs
Term 6 of 41
During ISS, the investigator must comply with regulatory requirements throughout the whole
study process. Four of these processes include...
- designing
- conducting
- recruiting
- reporting
- 21 CFR 312.50
- SOPs (standard operating procedures)
The National Physician Payment Transparency Program
equipment, products, or financial support
Term 7 of 41
Which MSL tier is responsible for training the sales team?
Budget Increment
MSL associates
Extension
False
, Term 8 of 41
True or False? In SRDs, no conclusions are presented to avoid MI bias.
True
False
Term 9 of 41
Why are ISS valuable to a pharma company?
- single function
- multidisciplinary team
The National Physician Payment Transparency Program
may identify an area of unmet needs for a drug's use
- pre-award
- submission/approval
- post-award
Term 10 of 41
What type of grant?
- request for re-budgeting of current award due to difference in allowable direct costs (from
initial plans)
New Funding
Budget Increment
Administrative Supplement
Renewal
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