Questions and CORRECT Answers
1571 - CORRECT ANSWER IND application; Permit to do research on humans for the
first time; has background info; and rationale; updated annually
1572 - CORRECT ANSWER Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP
IB - CORRECT ANSWER Clinical and non-clinical data on the investigational product
that is relevant to the study in human subjects; supplied prior to regulatory approval
Study type - Open Label - CORRECT ANSWER everyone knows the treatment
Study type - Single blind - CORRECT ANSWER one party knows Tx, usually the patient
does not know but the monitoring team does
Study type - Double Blind - CORRECT ANSWER 2 or more people are blinded, usually
the patient and monitoring tram do not know which drug is given.
A 3rd party unblinded pharmacist is used and an unblinded CRA is needed
Study Type - Double dummy - CORRECT ANSWER Use to blind similar Tx's; one is
active and one is placebo. This occurs when the drug and placebo cannot be made identical (pill
vs liquid)
Study Type - Parallel - CORRECT ANSWER Two groups of treatments. One group
receives only treatment A and another group receives only treatment B