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ممارسة سريرية جيدة

ممارسة سريرية جيدة

وصف: 

The tripartite harmonised ICH Guideline was finalised underStep 4 بشهر مايو 1996. تصف وثيقة 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.

Implementation

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

ادارة الاغذية والعقاقير:

Published in the Federal Register, 9 يمكن 1997, Vol. 62, No. 90, p. 25691-25709

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