ممارسة سريرية جيدة
The tripartite harmonised ICH Guideline was finalised underStep 4 بشهر مايو 1996. تصف هذه الممارسات السريرية الجيدة مسؤوليات وتوقعات جميع المشاركين في إجراء التجارب السريرية, 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
الاتحاد الأوروبي:
Adopted by CPMP, يوليو 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 May 1997, Vol. 62, لا. 90, ص. 25691-25709
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