良好临床实践

良好临床实践

描述:

The tripartite harmonised ICH Guideline was finalised underStep 4 在五月 1996. 本良好临床实践文件描述了所有参与者在进行临床试验中的责任和期望, 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

欧洲联盟:

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