QUESTIONS WITH SOLUTIONS GRADED A+
●● 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