乌克兰的干细胞治疗

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

乌克兰的干细胞治疗

Clinical Research Associate/Clinical Research Coordinator

Responsibilities The CRA/CRC is responsible for the monitoring or auditing of all activities subject to the, “ICH 良好临床实践: 综合指南,” (地面控制点), supporting client programs administrated by Watermark ensure project data and summary statements are of known and documented quality. Requirements Will be expected to travel extensively to study 阅读更多…

乌克兰的干细胞治疗

GCP стандарт

Стандарт GCP («Good Clinical Practice», Надлежащая клиническая практика , ГОСТ Р 52379-2005) — международный стандарт этических норм и качества научных исследований, описывающий правила разработки, проведения, ведения документации и отчётности об исследованиях, которые подразумевают участие человека в качестве испытуемого (临床研究). Соответствие исследования этому стандарту говорит о публичном соблюдении: прав участников исследования правил 阅读更多…

干细胞疗法