The anticipated benefit of the trial to the individual subject and society must outweigh the foreseeable risks and inconveniences.
The protection of the trial subject, which should be the most important consideration.
The responsibilities of the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
The responsibilities of the investigator and sponsor.
The informed consent of the trial subjects.
The study protocol and investigator’s brochure and the essential documentation required to undertake a clinical trial.
KeywordsHormone Replacement Therapy Trial Subject Patient Information Sheet Fracture Intervention Trial Lateral Spine Radiograph
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