Clinical Research Professionals
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 have marketing approval 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