Good Clinical Practices: 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. The tripartite harmonised ICH guideline was finalised ( Step 4 ) in May 1996.

EU : Adopted by CPMP, July 96, issued as CPMP/ICH/135/95/Step5, Explanatory Note and Comments to the above, issued as CPMP/768/97
MHLW : Adopted March 97, PAB Notification No.430, MHLW Ordinance No.28
FDA : Published in the Federal Register, Vol. 62, No. 90, May 9, 1997, pages 25691-25709E7

Status : Step 5
May 1996

http://www.ich.org/cache/compo/276-254-1.html