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Exam (elaborations)

ACRP CP Exam Questions with 100% Correct Answers

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1571 Correct Answer IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 Correct Answer Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB Correct 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 Correct Answer everyone knows the treatment Study type - Single blind Correct Answer one party knows Tx, usually the patient does not know but the monitoring team does Study type - Double Blind Correct 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 Correct 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 Correct Answer Two groups of treatments. One group receives only treatment A and another group receives only treatment B Study Type - Crossover Correct 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 Correct 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.

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ACRP CP
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Uploaded on
November 13, 2024
Number of pages
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Written in
2024/2025
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ACRP CP Exam Questions with 100%
Correct Answers
1571 Correct Answer IND application; Permit to do research on humans for the first
time; has background info; and rationale; updated annually

1572 Correct Answer Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP

IB Correct 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 Correct Answer everyone knows the treatment

Study type - Single blind Correct Answer one party knows Tx, usually the patient does
not know but the monitoring team does

Study type - Double Blind Correct 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 Correct 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 Correct Answer Two groups of treatments. One group receives
only treatment A and another group receives only treatment B

Study Type - Crossover Correct 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 Correct 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 Correct Answer Subjects are matched for similar groups; ex: Smokers, sex and
age

Study Type - Placebo control Correct Answer 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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