Use of Electronic Informed Consent使用电子知情同意书

一沙一叶

2016年12月14日，FDA颁布了一份指南《Use of Electronic Informed Consent使用电子知情同意书》
如文中所言：
This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.
这个指南推荐使用电子系统和程序，这些系统和程序可能使用多种电子媒体来获得关于某些受试人研究或者医药产品临床研究的“知情同意书”
This guidance provides recommendations on procedures that may be followed when using an eIC to help:
 Ensure protection of the rights, safety, and welfare of human subjects
 Facilitate the subject’s comprehension of the information presented during the eIC process
 Ensure that appropriate documentation of consent is obtained when electronic systems and processes that may employ multiple electronic media are used to obtain informed consent
 Ensure the quality and integrity of eIC data included in FDA applications and made available to FDA during inspections
使用eIC在以下方面会有所帮助：

确保保护受试人的权力、安全和福利；
方面受试人理解eIC过程中传递的信息；
在使用多种电子媒体来获得知情同意时，确保同意的文档获得
确保eIC数据的质量和完整性符合FDA法规要求并在FDA检查中可用

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