题目内容
________ is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
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______ 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.
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.
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.
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.
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