ACRP CP EXAM QUESTIONS AND ANSWERS 100% CORRECT!!

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 -ANS