İyi Klinik Uygulamaları
The tripartite harmonised ICH Guideline was finalised underStep 4 Mayısta 1996. Bu İyi Klinik Uygulamalar belgesi, klinik araştırmaların yürütülmesinde tüm katılımcıların sorumluluklarını ve beklentilerini açıklamaktadır., 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
AB:
Adopted by CPMP, Temmuz 1996, issued as CPMP/ICH/135/95/Step5, Explanatory Note and Comments to the above, issued as CPMP/768/97
MHLW:
Adopted March 1997, PAB Notification No. 430, MHLW Ordinance No. 28
FDA:
Published in the Federal Register, 9 Mayıs 1997, Vol. 62, HAYIR. 90, P. 25691-25709
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