2026 COMPLETE ANSWERS ACCURATE
⫸ 1572 Answer: Investigator statement; commitment, done nationally
and internationally by sponsors intending to hava marketing aproval for
IP
⫸ IB 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 Answer: everyone knows the treatment
⫸ Study type - Single blind Answer: one party knows Tx, usually the
patient does not know but the monitoring team does
⫸ Study type - Double Blind 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