Exam (elaborations)
ACRP CP FINAL EXAM LATEST 2024
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ACRP CP FINAL EXAM LATEST 2024
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ACRP CP FINAL EXAM LATEST 2024/2025 REALEXAM
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
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 - 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
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