ACRP CP Exam Questions & Answers (100% Verified )

ACRP CP Exam Questions & Ans 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 Define 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. wers (100% Verified )