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
...
ACRP CP Exam
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
Study Type - Active control Correct 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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