Baidu
map

指南&解读指南

订阅

MedSci主页 / 所有栏目 / 指南&解读指南

FDA研究数据技术一致性指南 v4.5.1（2020年7月更新）

2020-07-08 美国食品和药品监督管理局 FDA

数据

本《研究数据技术一致性指南》提供了关于如何使用位于FDA数据标准目录(目录)中的FDA支持的数据标准提交标准化研究数据的规范、建议和一般考虑。该指南补充了《以电子格式提供监管报告》的行业指南，即：《标

中文标题：

FDA研究数据技术一致性指南 v4.5.1（2020年7月更新）

发布机构：

美国食品和药品监督管理局

发布日期：

2020-07-08

简要介绍：

本《研究数据技术一致性指南》提供了关于如何使用位于FDA数据标准目录(目录)中的FDA支持的数据标准提交标准化研究数据的规范、建议和一般考虑。该指南补充了《以电子格式提供监管报告》的行业指南，即：《标准化研究数据(e-研究数据)》指南。

本指南取代以前所有的《研究数据规范》文件(版本1.0 - 2.0)和《药品评价和研究中心研究数据常见问题文件(版本1.0 -1.1)》。

本指南共有八章，其内容目录如下：

1、 介绍

2、规划和提供标准化的研究数据

3、交换格式：电子提交

4、研究数据提交格式：临床和非临床

5、治疗领域标准

6、术语

7、电子提交格式

8、研究数据验证和可追溯性

附录A：数据标准和可互操作的数据交换

附录B：供提交的试验摘要(TS)参数——临床

附录C：供提交的试验摘要(TS)参数——非临床

附录D：经FDA评估过的其它文件

附录E：研究数据文件夹结构示例

术语表

如需要美国FDA于2020年7月发布的《研究数据技术一致性指南》（英文，共65页）

评论区 (6)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=924719, encodeId=694f924e19d1, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Feb 15 11:11:33 CST 2021, time=2021-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=921456, encodeId=cab99214565d, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jan 30 21:26:40 CST 2021, time=2021-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916360, encodeId=114f916360c8, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Wed Jan 13 21:45:22 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916084, encodeId=03a091608403, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Tue Jan 12 22:57:48 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=809263, encodeId=1b5b80926328, content=了解一下, beContent=null, objectType=guider, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Aug 15 22:34:14 CST 2020, time=2020-08-15, status=1, ipAttribution=)]
    2021-02-15 wxl882001

    了解

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=924719, encodeId=694f924e19d1, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Feb 15 11:11:33 CST 2021, time=2021-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=921456, encodeId=cab99214565d, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jan 30 21:26:40 CST 2021, time=2021-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916360, encodeId=114f916360c8, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Wed Jan 13 21:45:22 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916084, encodeId=03a091608403, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Tue Jan 12 22:57:48 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=809263, encodeId=1b5b80926328, content=了解一下, beContent=null, objectType=guider, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Aug 15 22:34:14 CST 2020, time=2020-08-15, status=1, ipAttribution=)]
    2021-01-30 wxl882001

    了解

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=924719, encodeId=694f924e19d1, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Feb 15 11:11:33 CST 2021, time=2021-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=921456, encodeId=cab99214565d, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jan 30 21:26:40 CST 2021, time=2021-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916360, encodeId=114f916360c8, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Wed Jan 13 21:45:22 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916084, encodeId=03a091608403, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Tue Jan 12 22:57:48 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=809263, encodeId=1b5b80926328, content=了解一下, beContent=null, objectType=guider, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Aug 15 22:34:14 CST 2020, time=2020-08-15, status=1, ipAttribution=)]
    2021-01-13 wxl882001

    了解

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=924719, encodeId=694f924e19d1, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Feb 15 11:11:33 CST 2021, time=2021-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=921456, encodeId=cab99214565d, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jan 30 21:26:40 CST 2021, time=2021-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916360, encodeId=114f916360c8, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Wed Jan 13 21:45:22 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916084, encodeId=03a091608403, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Tue Jan 12 22:57:48 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=809263, encodeId=1b5b80926328, content=了解一下, beContent=null, objectType=guider, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Aug 15 22:34:14 CST 2020, time=2020-08-15, status=1, ipAttribution=)]
    2021-01-12 wxl882001

    了解

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=924719, encodeId=694f924e19d1, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Feb 15 11:11:33 CST 2021, time=2021-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=921456, encodeId=cab99214565d, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Jan 30 21:26:40 CST 2021, time=2021-01-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916360, encodeId=114f916360c8, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Wed Jan 13 21:45:22 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916084, encodeId=03a091608403, content=了解, beContent=null, objectType=guider, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Tue Jan 12 22:57:48 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=809263, encodeId=1b5b80926328, content=了解一下, beContent=null, objectType=guider, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Sat Aug 15 22:34:14 CST 2020, time=2020-08-15, status=1, ipAttribution=)]
    2020-08-15 wxl882001

    了解一下

    0

Baidu
map
Baidu
map
Baidu
map