What is Good Clinical Practice, GCP? GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with GCP assures that the rights, safety, and wellbeing of trial subject are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trail data are credible.
Statement from DHHS: The Good Clinical Practice Guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.
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