______ is an independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
A. IRP
B. IAB
C. IRB
D. IIB
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The first modern randomized, placebo controlled trial of streptomycin for tuberculosis in _______, attempted to address the bias concern by assigning treatments to patients using a random selection process.
A. 1945
B. 1948
C. 1950
D. 1954
In Phase II trials, the new drug or treatment is given to a group of _____________ people to determine its effectiveness and to further study its safety.
A. 100–500
B. 30–300
C. 100–300
D. 200–400
In Phase III trials, the new drug or treatment is given to large groups of _________________ people to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
A. 1,000–5,000
B. 1,000–3,000
C. 400–3,000
D. 600–4,000
After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment benefits, and optimal use in Phase ____ trials.
A. II
B. III
C. IV
D. V