ICH E6 (R2) Good clinical practice - Scientific guideline

This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Keywords: Good clinical practice (GCP), Ethics Committee, Institutional Review Board, investigator, sponsor, protocol, investigator's brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report


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