Category:
Research Papers
Sub-Category:
Biology / Medicine
Date Published:
May 03, 2021
Keywords:
subject; clinical trial, ICHGCP guidelines; sponsor; FDA; investigator
Abstract:
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects and was developed with consideration of the current good clinical standards of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO). Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, and that the clinical trial data are credible. This standard should be followed when generating clinical trial data that are intended to be submitted to regulatory body (US Food and Drug Administration [FDA])
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