ACRP CP Exam 2023 Verified 100% 1571 ` - Answer IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 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 Study Type - Double dummy - 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 - Answer Two groups of treatments. One group receives only treatment A and another group receives only treatment B Study Type - Crossover - Answer Usually Chronic disease; receives more than one Tx with a washout in between. A then B; could be randomized so the sequence changes Overall Survival - Answer the 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.Cohort - Answer Subjects are matched for similar groups; ex: Smokers, sex and age Study Type - Placebo control - Answer in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a placebo Study Type - Active control - Answer Done when use of placebo is unethical like antibiotics studies.Means that a known, effective treatment (as opposed to a placebo) is compared to an experimental treatment Randomization - Answer method used to equify distribution of Tx to subjects; to eliminate bias Stratification - Answer method used to control assignment based on variables; like disease status; ALLOWS BALANCED COMPARABILITY
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