Correct Answers
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