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ICH-GCP refers to Guideline E6(R1): Good Clinical Practice : Consolidated Guideline, prepared by the International Conference of Harmonisation.

It was finalised in May 1996 and describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs (ethics committees). GCPs cover aspects of monitoring, reporting and archiving of clinical trials, and Essential Documents.

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16y ago

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