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Good Clinical Practice

Good Clinical Practice

描述: 

The tripartite harmonised ICH Guideline was finalised underStep 4 in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, 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

EU:

Adopted by CPMP, 七月 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

美国食品药品监督管理局:

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

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乌克兰的干细胞治疗

Current problems of gastroenterology and abdominal Surgery 2024 医学会议

Current problems of gastroenterology and abdominal Surgery medical conference Registration Conference Description Programme 10.00 Gastroenterology lectures: • New in gastroenterology and hepatology and Coloproctology. 10.30 • Dysbacteriosis intestinecurrent status of the problem. Round Table. 10.45 Omeprazole VS Pantoprazole in gastroenterology 11.30 Acid disorders. The algorithm of the physician Chronic 阅读更多