ACRP CP Exam/21 Questions with 100% Accurate Answe
ACRP CP Exam/21 Questions with 100% Accurate Answe
ACRP CP Exam/21 Questions with 100% Accurate Answe
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ACRP CP Exam/21 Questions with 100%
Accurate Answers
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
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