ACRP CP Exam Questions and Answers Complete
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 apr...
acrp cp exam questions and answers complete 1571 ind application permit to do research on humans for the first time has background info and rationale updated annually 1572 investigator statemen
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ACRP CP Exam Questions and Answers Complete
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
Study Type - Active control
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
Randomization
method used to equify distribution of Tx to subjects; to eliminate bias
Stratification
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