ACRP CP Exam
1571 ` - ANSIND application; Permit to do research on humans for the first time; has
background info; and rationale; updated annually
1572 - ANSInvestigator statement; commitment, done nationally and internationally by
sponsors intending to hava marketing aproval for IP
IB - ANSClinical 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 - ANSeveryone knows the treatment
Study type - Single blind - ANSone party knows Tx, usually the patient does not know but
the monitoring team does
Study type - Double Blind - ANS2 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 - ANSUse 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 - ANSTwo groups of treatments. One group receives only treatment A
and another group receives only treatment B
Study Type - Crossover - ANSUsually Chronic disease; receives more than one Tx with a
washout in between. A then B; could be randomized so the sequence changes
Overall Survival - ANSthe 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 - ANSSubjects are matched for similar groups; ex: Smokers, sex and age
Study Type - Placebo control - ANSin addition to a group of subjects that receives the
treatment to be evaluated, a separate control group receives a placebo
Study Type - Active control - ANSDone 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 - ANSmethod used to equify distribution of Tx to subjects; to eliminate bias
1571 ` - ANSIND application; Permit to do research on humans for the first time; has
background info; and rationale; updated annually
1572 - ANSInvestigator statement; commitment, done nationally and internationally by
sponsors intending to hava marketing aproval for IP
IB - ANSClinical 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 - ANSeveryone knows the treatment
Study type - Single blind - ANSone party knows Tx, usually the patient does not know but
the monitoring team does
Study type - Double Blind - ANS2 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 - ANSUse 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 - ANSTwo groups of treatments. One group receives only treatment A
and another group receives only treatment B
Study Type - Crossover - ANSUsually Chronic disease; receives more than one Tx with a
washout in between. A then B; could be randomized so the sequence changes
Overall Survival - ANSthe 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 - ANSSubjects are matched for similar groups; ex: Smokers, sex and age
Study Type - Placebo control - ANSin addition to a group of subjects that receives the
treatment to be evaluated, a separate control group receives a placebo
Study Type - Active control - ANSDone 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 - ANSmethod used to equify distribution of Tx to subjects; to eliminate bias
