ACRP CP Exam (Latest ) Graded A

IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP 1B - 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 - everyone knows the treatment Study type - Single blind - one party knows TX, usually the patient does not know but the monitoring team does Study type - Double Blind - 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 - 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 - Two groups of treatments. One group receives only treatment A and another group receives only treatment B Study Type - Crossover - Usually Chronic disease; receives more than one Txwith a washout in between. A then B; could be randomized so the sequence changes Overall Survival - 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 - Subjects are matched for similar groups; ex: Smokers, sex and age Study Type - Placebo control - in addition to a group of subjects that receives the treatment to be evaluated, a separate control g