ICH GCP Firsts
Which of the following is the first paragraph in Chapter 2 of ICH GCP?
Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society.
The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial
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