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1571 ` - ANSWERIND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - ANSWERInvestigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - ANSWERClinical 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 - ANSWEReveryone knows the treatment Study type - Single blind - ANSWERone party knows Tx, usually the patient does not know but the monitoring team does Study type - Double Blind - ANSWER2 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 - ANSWERUse 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 - ANSWERTwo groups of treatments. One group receives only treatment A and another group receives only treatment B Study Type - Crossover - ANSWERUsually Chronic disease; receives more than one Tx with a washout in between. A then B; could be randomized so the sequence changes Overall Survival - ANSWERthe length of time from treatment until time of death. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.