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. Compliance
with this standard provides public assurance that the rights, safety
and well-being of trial subjects are protected, consistent with the
principles that have their origin in the Declaration of Helsinki,
and that the clinical trial data are credible.
objective of this ICH GCP Guideline is to provide a unified standard
for the European Union (EU), Japan and the United States to facilitate
the mutual acceptance of clinical data by the regulatory authorities
in these jurisdictions.
guideline was developed with consideration of the current good clinical
practices 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).
guideline should be followed when generating clinical trial data that
are intended to be submitted to regulatory authorities.
principles established in this guideline may also be applied to other
clinical investigations that may have an impact on the safety and
well-being of human subjects.