FDA 20160516 Guidance Use of EHR Data in Clinical Investigations

BH160217 · 发表于 2016-5-19 10:10:14

欢迎您注册蒲公英

您需要登录才可以下载或查看，没有帐号？立即注册

x

玩的越来越高端了跟不上的节奏。。。This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations.

数据完整性同样体现于此。。
When EHRs are used as a source of data in clinical investigations, sponsors should ensure that the EHRs they use and the processes and policies for their use provide electronic source data that are attributable, legible, contemporaneous, original, and accurate (ALCOA)

胜利者 · 发表于 2016-5-19 11:02:58

沙发

sanjian0 · 发表于 2016-5-19 11:19:58

楼主能翻译下吗，正在学习中，英语现在还是有点吃力的，拜托了

slliy · 发表于 2016-5-19 11:21:01

国内要直接跟进？那还不如赶快抹脖子

BH160217 · 发表于 2016-5-19 12:49:48

sanjian0 发表于 2016-5-19 11:19
楼主能翻译下吗，正在学习中，英语现在还是有点吃力的，拜托了

draft 没必要仔细翻译看看了解下就行了

BH160217 · 发表于 2016-5-19 12:51:11

slliy 发表于 2016-5-19 11:21
国内要直接跟进？那还不如赶快抹脖子

没那么快瞅瞅那群损色。。。。

syhorchid · 发表于 2016-5-19 14:38:37

下载慢慢学习

[药品研发] FDA 20160516 Guidance Use of EHR Data in Clinical Investigations

欢迎您注册蒲公英

相关帖子