ACRP CP EXAM WITH LATEST QUESTIONS AND 100% CORRECT ANSWERS ALREADY GRADED A+
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Course
ACRP CP
Institution
ACRP CP
ACRP CP EXAM WITH LATEST
QUESTIONS AND 100% CORRECT
ANSWERS ALREADY GRADED A+
1571 - ANS-IND application; Permit to do research on humans for the first time; has background info;
and rationale; updated annually
1572 - ANS-Investigator statement; commitment, done nationally and internationa...
ACRP CP EXAM 2024-2025 WITH LATEST
QUESTIONS AND 100% CORRECT
ANSWERS ALREADY GRADED A+
1571 - ANS-IND application; Permit to do research on humans for the first time; has background info;
and rationale; updated annually
1572 - ANS-Investigator statement; commitment, done nationally and internationally by sponsors
intending to hava marketing aproval for IP
IB - ANS-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 - Placebo control - ANS-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 - ANS-Done when use of placebo is unethical like antibiotics studies.
Study type - Open Label - ANS-everyone knows the treatment
, Study type - Single blind - ANS-one party knows Tx, usually the patient does not know but the
monitoring team does
Study type - Double Blind - ANS-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 - ANS-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 - ANS-Two groups of treatments. One group receives only treatment A and another
group receives only treatment B
Study Type - Crossover - ANS-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 - ANS-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 - ANS-Subjects are matched for similar groups; ex: Smokers, sex and age
Means that a known, effective treatment (as opposed to a placebo) is compared to an experimental
treatment
Define Randomization - ANS-method used to equify distribution of Tx to subjects; to eliminate bias
Define Stratification - ANS-method used to control assignment based on variables; like disease status;
ALLOWS BALANCED COMPARABILITY
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