Exam (elaborations)
ACRP CP Exam (Latest 2023 – 2024) Graded A
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ACRP CP Exam (Latest 2023 – 2024) Graded A
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ACRP CP Exam (Latest 2023 – 2024)Graded A
1571 ` - 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
IB - 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 Tx with 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 group receives a placebo
Study Type - Active control - Done when use of placebo is unethical like antibiotics studies.
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