E6(R1): Good Clinical Practice : Consolidated Guideline

Regulatory Resource: E6(R1): Good Clinical Practice : Consolidated Guideline

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.

Download Document: E6(R1): Good Clinical Practice : Consolidated Guideline

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