The tripartite harmonised ICH Guideline was finalised under Passo 4 a maggio 1996. Questo documento sulle Buone Pratiche Cliniche descrive le responsabilità e le aspettative di tutti i partecipanti nello svolgimento degli studi clinici, 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.
Adopted by CPMP, luglio 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 Maggio 1997, vol. 62, No. 90, p. 25691-25709