E6 (R3) moves beyond the ALCOAC data integrity requirements of R2 and focuses on the broader output requirement of data reliability - results should be able to be accepted with 'confidence', and in turn 'support good decision-making'. A beneficial side-effect of this lean, proportional risk-...
In the prior version of ICH E6 in Section 5.2. it was stated that sponsors may transfer responsibilities to CROs, and the transfer should be in writing, and any responsibilities not specifically transferred should be retained by the sponsor.2...
需要金币:*** 金币(10金币=人民币1元) E6(R2)-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6(R1)良好临床实践ICH-E6(R1)的综合附录.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry ...