Bonnes pratiques cliniques

The tripartite harmonised ICH Guideline was finalised underÉtape 4 en mai 1996. Ce document de bonnes pratiques cliniques décrit les responsabilités et les attentes de tous les participants à la conduite des essais cliniques., 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.

Étape 5

Adopted by CPMP, Juillet 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 Peut 1997, Vol. 62, Non. 90, p. 25691-25709