为您找到"
ICH-GCP 10.2 Roles & Responsibilities(2)
"相关结果约100,000,000个
1、 保护研究参与者的权利和安全 , 2、 遵守研究方案 ,以及 3、 准确、完整地报告研究数据 。 The following descriptions are intended to clarify roles and responsibilities that must be fulfilled in all CTN studies, not to define specific positions held by individuals. The position titles used here m...
Ⅱ、Briefly describe how these roles and responsibilities are fulfilled in clinical studies. Ⅲ、Discuss the roles and responsibilities of other individuals and groups involved in studies. 本单元将: 1、讨论GCP指南中概述的发起人和主要研究者的角色和责任。 2、简要描述这些角色和职责在临床研究中是如何履...
This topic is also discussed in the Roles and Responsibilities module. 角色和职责模块中也讨论了此主题。 Based on GCP guidelines, other Investigator responsibilities include (ICH GCP E6, 4.6): Ⅰ、Ensuring Investigational Product accountability Ⅱ、Assigning duties for Investigational Products to a pharma...
ix、Any other documents needed to fulfill the IRB's responsibilities. 2、 回顾和理解整个学习计划。为提供全面审查,IRB应获得以下文件 (完整研究计划中包含的信息示例): (1) 研究方案 和 方案修订 。 (2)研究人员拟使用的 书面知情同意书 和同意书更新。 (3)与参与者 招聘程序有关的文件 和 其他媒体 (...
(ICH GCP 5.1.1)该责任包括监督所有 QA系统以及由其他方 (即CRO或CRO的分包商)代表发起人执行或管理的任何试验相关功能(ICH GCP 5.2.2) Investigators and every member of the protocol team are expected to perform his or her duties diligently and thoroughly, thus ensuring that the trial is conducted ...
The consent document must state (ICH GCP 4.8.10): i、That the trial involves research. ii、The purpose of the trial. 同意书必须说明(ICH GCP 4.8.10): (1) 试验涉及研究 。 (2) 试验的目的 。 The consent document must state (ICH GCP 4.8.10): The trial treatment(s) and the ...
1、遗漏(即未按协议要求执行) 2、补充(即协议中不要求的任何行动) 3、协议中描述的任何程序的变更。 Protocol violations may occur due to human error. However, every attempt should be made to keep them at a minimum. Each violation and the action taken to correct the situation that led to the ...
1、参与者授权; 2、包含在有限的数据集中;或 3、作为取消识别数据发布。 Other instances where accounting is not required include for national security or intelligence purposes, and disclosure to correctional institutions or law enforcement officials. 其他不需要会计的情况包括出于 国家安全或情报目的 ,以及 ...
1.公司所得税(Corporate Income Tax) 加拿大联邦政府及10省3区均开征公司所得税。加拿大的所得税制度规定了开征所得税的两个基本概念,即收入来源和住所。 (1)收入来源 加拿大所得税法(包括联邦和省/区)规定了4种主要收入来源:经营(所得),财产(所得),工资和资本收益。 (2)公司住所 一个公司如果在加拿大注...