ACRP CP Exam 2023 Verified 100%
1571 ` - Answer IND application; Permit to do research on humans for the first time;
has background info; and rationale; updated annually
1572 - Answer Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP
IB - 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 - Answer everyone knows the treatment
Study type - Single blind - Answer one party knows Tx, usually the patient does not
know but the monitoring team does
Study type - Double Blind - 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 - 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 - Answer Two groups of treatments. One group receives only
treatment A and another group receives only treatment B
Study Type - Crossover - 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 - 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 - Answer Subjects are matched for similar groups; ex: Smokers, sex and age
Study Type - Placebo control - 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 - 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
Randomization - Answer method used to equify distribution of Tx to subjects; to
eliminate bias
Stratification - Answer method used to control assignment based on variables; like
disease status; ALLOWS BALANCED COMPARABILITY
1571 ` - Answer IND application; Permit to do research on humans for the first time;
has background info; and rationale; updated annually
1572 - Answer Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP
IB - 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 - Answer everyone knows the treatment
Study type - Single blind - Answer one party knows Tx, usually the patient does not
know but the monitoring team does
Study type - Double Blind - 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 - 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 - Answer Two groups of treatments. One group receives only
treatment A and another group receives only treatment B
Study Type - Crossover - 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 - 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 - Answer Subjects are matched for similar groups; ex: Smokers, sex and age
Study Type - Placebo control - 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 - 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
Randomization - Answer method used to equify distribution of Tx to subjects; to
eliminate bias
Stratification - Answer method used to control assignment based on variables; like
disease status; ALLOWS BALANCED COMPARABILITY
