Good Clinical Practice

The tripartite harmonised ICH Guideline was finalised under 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.

Step 5

Adopted by CPMP, July 1996, issued as CPMP/ICH/135/95/Step5, Explanatory Note and Comments to the above, issued as CPMP/768/97

Adopted March 1997, PAB Notification No. 430, MHLW Ordinance No. 28

Published in the Federal Register, 9 May 1997, Vol. 62, No. 90, p. 25691-25709