ACRP CP Exam 2023 Verified 100%

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 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. Define 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 Define Randomization - ANSWER method used to equify distribution of Tx to subjects; to eliminate bias Define Stratification - ANSWER method used to control assignment based on variables; like disease status; ALLOWS BALANCED COMPARABILITY What are PK studies?