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
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
